Adaptive COVID-19 Treatment Trial 4 (ACTT-4) | NCT04640168

Status Module

Description Module

Detailed Description

This study is an adaptive randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. New arms can be introduced according to scientific and public health needs. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. This adaptive platform is used to rapidly evaluate different therapeutics in a population of those hospitalized with moderate to severe COVID-19. The platform will provide a common framework sharing a similar population, design, endpoints, and safety oversight. New stages with new therapeutics can be introduced. One independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data in all stages to make recommendations about early study closure or changes to study arms.

ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone.

All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized).

The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29. The key secondary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir according to clinical status (8-point ordinal scale) at Day 15.

Contacts:

20-0006 Central Contact

Telephone: 1 (301) 7617948

Email: DMIDClinicalTrials@niaid.nih.gov

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remdesivir plus Baricitinib	Experimental	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.	Drug: Baricitinib Other: Placebo Drug: Remdesivir
Remdesivir plus Dexamethasone	Experimental	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.	Drug: Dexamethasone Other: Placebo Drug: Remdesivir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Baricitinib	Drug	Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name [1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl]acetonitrile. Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)	Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.	Day 1 through Day 29
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Race	Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.	Day 1 through Day 29
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Ethnicity	Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.	Day 1 through Day 29
The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) by Sex	Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Alanine Aminotransferase (ALT)	Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.	Days 1, 3, 5, 8, 11, 15 and 29

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized with symptoms suggestive of COVID-19.
Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures and understands and agrees to comply with planned study procedures.
Male or non-pregnant female adult > / = 18 years of age at time of enrollment.
Illness of any duration and has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay (e.g. NAAT, antigen test) in any respiratory specimen or saliva < / = 14 days prior to randomization.
Within the 7 days prior to randomization requiring new use of supplemental oxygen (or increased oxygen requirement if on chronic oxygen) and requires at the time of randomization low or high flow oxygen devices or use of non-invasive mechanical ventilation (ordinal scale category 5 or 6).
Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
Agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through Day 29.

Exclusion Criteria:

Prior enrollment in ACTT-3 or ACTT-4. Note: this includes subjects whose participation in ACTT was terminated early.
On invasive mechanical ventilation at the time of randomization (ordinal scale category 7).
Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours of randomization.
Positive test for influenza virus during the current illness (influenza testing is not required by protocol).
Subjects with a low glomerular filtration rate (eGFR), specifically:
1. Subjects with an eGFR 15-30 mL/min are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation.
2. All subjects with an eGFR <15 mL/min
3. All subjects on hemodialysis and/or hemofiltration at screening, irrespective of eGFR are excluded.
Neutropenia (absolute neutrophil count <700 cells/microliter, 0.7 x 10^3/microliter).
Lymphopenia (absolute lymphocyte count <200 cells/microliter, 0.20 x 10^3/microliter).
Received five or more doses of remdesivir including the loading dose, outside of the study as treatment for COVID-19.
Pregnancy or breast feeding (lactating women who agree to discard breast milk from Day 1 until two weeks after the last study product is given are not excluded).
Allergy to any study medication.
Received convalescent plasma or intravenous immunoglobulin [IVIg] for COVID-19, the current illness for which they are being enrolled.
Received any of the following in the two weeks prior to screening as treatment of COVID-19:
- More than one dose of baricitinib for the treatment of COVID-19;
- Other small molecule tyrosine kinase inhibitors (e.g. imatinib, gefitinib, acalabrutinib, etc.);
- monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], etc.);
- monoclonal antibodies targeting T-cells or B-cells as treatment for COVID-19. Note: receipt of anti-SARS-CoV-2 monoclonal antibody (mAb) prior to enrollment (e.g. bamlanivimab) for their current COVID-19 illness is not exclusionary
Use of probenecid that cannot be discontinued at study enrollment.
Received 6 mg or more of dexamethasone by mouth (po) or Intravenous (IV) (or equivalent for other glucocorticoids) in one day, on more than one day, in the 7 days prior to time of randomization. Note: 6 mg dexamethasone dose equivalents include 40 mg prednisone, 32 mg methylprednisolone and 160 mg hydrocortisone.
Received > / = 20 mg/day of prednisone po or IV (or equivalent for other glucocorticoids) for > / = 14 consecutive days in the 4 weeks prior to screening.
Have diagnosis of current active or latent tuberculosis (TB), if known, treated for less than 4 weeks with appropriate therapy (by history only, no screening required).
Serious infection (besides COVID-19), immunosuppressive state, or immunosuppressive medications that in the opinion of the investigator could constitute a risk when taking baricitinib or dexamethasone.
Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations including SARS-CoV-2 vaccine is allowed for all subjects.
Had a known Venous thromboembolism (VTE)(deep vein thrombosis [DVT] or pulmonary embolism [PE]) during the current COVID-19 illness.

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham School of Medicine - Infectious Disease		Birmingham	Alabama	35233	United States

PubMed Identifier	Type	Citation	Retractions
36442063	Derived	Potter GE, Bonnett T, Rubenstein K, Lindholm DA, Rapaka RR, Doernberg SB, Lye DC, Mularski RA, Hynes NA, Kline S, Paules CI, Wolfe CR, Frank MG, Rouphael NG, Deye GA, Sweeney DA, Colombo RE, Davey RT Jr, Mehta AK, Whitaker JA, Castro JG, Amin AN, Colombo CJ, Levine CB, Jain MK, Maves RC, Marconi VC, Grossberg R, Hozayen S, Burgess TH, Atmar RL, Ganesan A, Gomez CA, Benson CA, Lopez de Castilla D, Ahuja N, George SL, Nayak SU, Cohen SH, Lalani T, Short WR, Erdmann N, Tomashek KM, Tebas P. Temporal Improvements in COVID-19 Outcomes for Hospitalized Adults: A Post Hoc Observational Study of Remdesivir Group Participants in the Adaptive COVID-19 Treatment Trial. Ann Intern Med. 2022 Dec;175(12):1716-1727. doi: 10.7326/M22-2116. Epub 2022 Nov 29.
35617986

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course. Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name [1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl]acetonitrile. Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. Placebo: Placebo matching intravenous dexamethasone. Remdesivir: Drug remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 18, 2021	Feb 10, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)

Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.

The modified intention-to-treat (mITT) population includes all participants who were randomized. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.

Posted

Number

95% Confidence Interval

Proportion of participants

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Units	Counts
Participants	OG000515 OG001494

Title

Denominators

Categories

Title	Measurements
	OG0000.87(0.84 to 0.90) OG0010.88(0.84 to 0.90)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Chi-squared		0.909														Superiority

Secondary

Change From Baseline in Alanine Aminotransferase (ALT)

Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

Units/Liter (U/L)

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Aspartate Aminotransferase (AST)

Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

U/L

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in C-reactive Protein (CRP)

Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, the earliest post-treatment dose was used. Participants from sites reporting high sensitivity CRP were excluded.

Posted

Mean

95% Confidence Interval

milligrams/liter (mg/L)

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Creatinine

Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

mg/dL

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in D-dimer Concentration

Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The mITT population includes all participants by their randomized treatment assignment and baseline ordinal score. For any missing data, if results were available for visits before or after that visit, the average of the two nearest visits was imputed for all missing visits between them. If a participant died or was lost to follow-up, their last available observation was carried forward. If baseline was missing, another pre-treatment dose was used, or the earliest post-treatment dose was used.

Posted

Mean

95% Confidence Interval

mg/L fibrinogen-equivalent units (FEU)

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone

Secondary

Change From Baseline in Glucose

Blood to evaluate glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

mg/dL

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Hemoglobin

Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

grams/deciliter (g/dL)

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Platelets

Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

10^9 cells/liter

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Prothrombin International Normalized Ratio (INR)

Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

ratio

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Total Bilirubin

Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

mg/dL

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in White Blood Cell Count (WBC)

Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

10^9 cells/liter

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Neutrophils

Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

10^9 cells/liter

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Lymphocytes

Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

10^9 cells/liter

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Monocytes

Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

10^9 cells/liter

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Basophils

Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

10^9 cells/liter

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Change From Baseline in Eosinophils

Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.

Posted

Mean

95% Confidence Interval

10^9 cells/liter

Days 1, 3, 5, 8, 11, 15 and 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)

Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.

The safety population includes all participants with available data post baseline, analyzed as treated.

Posted

Number

percentage of participants

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants Reporting Serious Adverse Events (SAEs)

An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

The safety population includes all participants with available data post baseline, analyzed as treated.

Posted

Number

percentage of participants

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Days of Invasive Mechanical Ventilation / Extracorporeal Membrane Oxygenation (ECMO)

Duration of invasive ventilation/ECMO was measured in days among participants who required invasive ventilation, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

The analysis population is restricted to randomized participants who were on invasive ventilation.

Posted

Median

Inter-Quartile Range

Days

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Days of Non-invasive Ventilation/High Flow Oxygen

Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

The analysis population is restricted to randomized participants who were not on noninvasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.

Posted

Median

Inter-Quartile Range

Days

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Duration of Supplemental Oxygen Use

Duration of supplemental oxygen use was measured in days among participants who were on oxygen at baseline, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

The analysis population is restricted to randomized participants who were on oxygen at baseline.

Posted

Median

Inter-Quartile Range

Days

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Desirability of Outcome Ranking (DOOR) at Day 15

Desirability of Outcome Ranking (DOOR) based on ordinal scale: 1) Recovered (category 1, 2 or 3 on ordinal scale); 2) Improved (> / = 1 category improvement of ordinal scale compared with baseline) & no serious adverse event (SAE); 3) Improved (> / = 1 category improvement of the ordinal scale compared with baseline) & SAE (related or unrelated); 4) No change in ordinal scale from baseline & no SAE; 5) No change in ordinal scale from baseline & SAE (related or unrelated); 6) Worsening (> / = 1 category worse in ordinal scale from baseline); 7) Death.

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 through Day 15

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Desirability of Outcome Ranking (DOOR) at Day 29

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Duration of Hospitalization

Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.

The modified intent-to-treat (ITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Median

Inter-Quartile Range

Days

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Number of Participants With Discontinuation or Temporary Suspension of Study Product Administration

Discontinuation or temporary suspension of study product administration, including participants who died or were discharged, was evaluated for each study product/placebo.

The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Count of Participants

Participants

Day 1 through Day 10

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

14-day Participant Mortality

The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.

The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

Proportion of participants

Day 1 through Day 15

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

28-day Participant Mortality

The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.

The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

Proportion of participants

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, participant is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.

The mITT population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 1

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001

Secondary

Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 3

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 5

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 8

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 11

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 15

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 22

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

percentage of participants

Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Percentage of Participants Meeting Criteria for Each of the 8 Ordinal Scale Categories

The ordinal scale categories are defined as: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

Percentage of participants

Day 15

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001

Secondary

The Proportion of Participants Not Meeting Criteria for One of the Three Most Severe Ordinal Scale Categories at Any Time.

The three most severe ordinal scale categories are: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices.

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Number

95% Confidence Interval

Proportion of participants

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Time to an Improvement of One Category From Baseline Using an Ordinal Scale

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. Time to improvement by at least one category was determined for each participant.

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Median

95% Confidence Interval

Days

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Time to an Improvement of Two Categories From Baseline Using an Ordinal Scale

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use. Time to improvement by at least two categories was determined for each participant.

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Median

95% Confidence Interval

Days

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Secondary

Time to Recovery

Day of recovery is defined as the first day on which the participant satisfies one of the following three ordinal scale categories: 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, but has new or increased limitation on activities and/or new or increased requirement for home oxygen over baseline, pre-COVID-19 status; 1) Not hospitalized, patient is back to their baseline, pre-COVID-19 status, that is, no new or increased limitations on activities and no new or increased oxygen use.

The modified intention-to-treat (mITT) population includes all participants who were randomized, classified by their randomized treatment assignment.

Posted

Median

Inter-Quartile Range

Days

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.

Primary

Posted

Number

95% Confidence Interval

Proportion of participants

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone

Primary

The modified intention-to-treat (mITT) population includes all participants who were randomized and for whom ethnicity was reported. mITT participants were classified by their randomized treatment assignment and their baseline ordinal score, which is not necessarily equivalent to the disease severity stratum to which the participant was randomized at enrollment. One participant was excluded from mITT analyses due to a baseline ordinal score of 4.

Posted

Number

95% Confidence Interval

Proportion of participants

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone

Primary

Posted

Number

95% Confidence Interval

Proportion of participants

Day 1 through Day 29

ID	Title	Description
OG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
OG001	Remdesivir Plus Dexamethasone

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0011 events1 affected482 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected503 at risk EG0013 events3 affected482 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Arrhythmia	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0011 events1 affected482 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Bradycardia	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Cardiac arrest	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected503 at risk EG0012 events2 affected482 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected503 at risk EG0010 events0 affected482 at risk
Myocardial infarction	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0012 events2 affected482 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0012 events2 affected482 at risk
Retinal artery occlusion	Eye disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Colitis	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0011 events1 affected482 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected503 at risk EG0017 events7 affected482 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
COVID-19	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Cellulitis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Fungal sepsis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Gastroenteritis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Pneumonia	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0008 events8 affected503 at risk EG0013 events3 affected482 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected503 at risk EG0013 events3 affected482 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Sepsis	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0004 events3 affected503 at risk EG0014 events4 affected482 at risk
Septic shock	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0006 events6 affected503 at risk EG0012 events2 affected482 at risk
Urinary tract infection	Infections and infestations	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Glomerular filtration rate decreased	Investigations	MedDRA (24.0)	Systematic Assessment	EG0002 events2 affected503 at risk EG0012 events2 affected482 at risk
Haemoglobin decreased	Investigations	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Hepatic enzyme increased	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Transaminases increased	Investigations	MedDRA (24.0)	Systematic Assessment	EG0001 events1 affected503 at risk EG0011 events1 affected482 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected503 at risk EG0013 events3 affected482 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (24.0)	Systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0003 events3 affected503 at risk EG0010 events0 affected482 at risk
Dizziness	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Ischaemic neuropathy	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Seizure	Nervous system disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Delirium	Psychiatric disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Substance use disorder	Psychiatric disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0009 events9 affected503 at risk EG0014 events4 affected482 at risk
Renal failure	Renal and urinary disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected503 at risk EG0010 events0 affected482 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected503 at risk EG0010 events0 affected482 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00012 events12 affected503 at risk EG00116 events16 affected482 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected503 at risk EG0014 events4 affected482 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0000 events0 affected503 at risk EG0011 events1 affected482 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0011 events1 affected482 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0011 events1 affected482 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00010 events10 affected503 at risk EG0018 events8 affected482 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG0005 events5 affected503 at risk EG00110 events10 affected482 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (24.0)	Non-systematic Assessment	EG00052 events52 affected503 at risk EG00140 events40 affected482 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0010 events0 affected482 at risk
Hypotension	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0002 events2 affected503 at risk EG0010 events0 affected482 at risk
Shock	Vascular disorders	MedDRA (24.0)	Non-systematic Assessment	EG0001 events1 affected503 at risk EG0012 events2 affected482 at risk

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Title	Description
BG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
BG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Remdesivir Plus Baricitinib	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; 4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and dexamethasone placebo administered as an intravenous injection daily while hospitalized for up to a 10-day total course.	28	516	95	503	16	503
EG001	Remdesivir Plus Dexamethasone	200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 10-day total course; baricitinib placebo administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course; and 6 mg of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course.	34	494	94	482	34	482

ID	Term
C000596027	baricitinib
D003907	Dexamethasone
C000606551	remdesivir