MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Trea... | NCT05780463

Status Module

Name	Class
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)	NETWORK
University of Copenhagen	OTHER
Medical Research Council	OTHER_GOV

Description Module

Detailed Description

This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of MP0420 in hospitalized patients infected with COVID-19.

This is a randomized, blinded, controlled sub-study of MP0420 plus current SOC against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo.

Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: participants without organ failure (severity stratum 1) and participants with organ failure (severity stratum 2).

An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. At the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5.

If MP0420 passes the futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm, or futility for the investigational agent. Participants will be followed for 18 months following randomization.

This trial will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MP0420 plus SOC	Experimental	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion	Drug: MP0420 Biological: Remdesivir
Placebo plus SOC	Placebo Comparator	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion	Drug: Placebo Biological: Remdesivir

Name	Type	Description	Arm Group Labels	Other Names
MP0420	Drug	MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains.	MP0420 plus SOC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Sustained Recovery	Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.	Through Day 90
Number of Participants With an Ordinal Outcome on Day 5	Ordinal outcome with 7 mutually exclusive categories	Status on Day 5

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Died From All Causes	All-cause mortality	Through Day 90
Number of Participants With a Safety Outcome Through Day 5	Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5

Eligibility Module

Name	Affiliation	Role
Jens Lundgren, Prof.	INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen	Principal Investigator
James Neaton, Prof.	INSIGHT Statistical and Data Management Center, University of Minnesota	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue		Tucson	Arizona	85719	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35939810	Result	ACTIV-3/TICO Study Group; Barkauskas C, Mylonakis E, Poulakou G, Young BE, Vock DM, Siegel L, Engen N, Grandits G, Mosaly NR, Vekstein AM, Rogers R, Shehadeh F, Kaczynski M, Mylona EK, Syrigos KN, Rapti V, Lye DC, Hui DS, Leither L, Knowlton KU, Jain MK, Marines-Price R, Osuji A, Overcash JS, Kalomenidis I, Barmparessou Z, Waters M, Zepeda K, Chen P, Torbati S, Kiweewa F, Sebudde N, Almasri E, Hughes A, Bhagani SR, Rodger A, Sandkovsky U, Gottlieb RL, Nnakelu E, Trautner B, Menon V, Lutaakome J, Matthay M, Robinson P, Protopapas K, Koulouris N, Kimuli I, Baduashvili A, Braun DL, Gunthard HF, Ramachandruni S, Kidega R, Kim K, Hatlen TJ, Phillips AN, Murray DD, Jensen TO, Padilla ML, Accardi EX, Shaw-Saliba K, Dewar RL, Teitelbaum M, Natarajan V, Laverdure S, Highbarger HC, Rehman MT, Vogel S, Vallee D, Crew P, Atri N, Schechner AJ, Pett S, Hudson F, Badrock J, Touloumi G, Brown SM, Self WH, North CM, Ginde AA, Chang CC, Kelleher A, Nagy-Agren S, Vasudeva S, Looney D, Nguyen HH, Sanchez A, Weintrob AC, Grund B, Sharma S, Reilly CS, Paredes R, Bednarska A, Gerry NP, Babiker AG, Davey VJ, Gelijns AC, Higgs ES, Kan V, Matthews G, Thompson BT, Legenne P, Chandra R, Lane HC, Neaton JD, Lundgren JD. Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial. Ann Intern Med. 2022 Sep;175(9):1266-1274. doi: 10.7326/M22-1503. Epub 2022 Aug 9.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MP0420 Plus SOC	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent

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: Trial H5 Protocol	Apr 9, 2021

Arm/Group Information

ID	Title	Description
BG000	MP0420 Plus SOC	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent
BG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.8± 14.9 BG00156.6± 16.6 BG00256.7± 15.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000100 BG001110 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00041 BG00138 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG00014 BG00115 BG002

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

Number of Participants With Sustained Recovery

Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.

Posted

Count of Participants

Participants

Through Day 90

ID	Title	Description
OG000	MP0420 Plus SOC	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Units	Counts
Participants	OG000247 OG001238

Title

Denominators

Categories

Title	Measurements
	OG000203 OG001190

Primary

Number of Participants With an Ordinal Outcome on Day 5

Ordinal outcome with 7 mutually exclusive categories

Posted

Count of Participants

Participants

Status on Day 5

ID	Title	Description
OG000	MP0420 Plus SOC	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Died From All Causes

All-cause mortality

Posted

Count of Participants

Participants

Through Day 90

ID	Title	Description
OG000	MP0420 Plus SOC	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Units	Counts
Participants	OG000

Secondary

Number of Participants With a Safety Outcome Through Day 5

Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5

Posted

Count of Participants

Participants

Through Day 5

ID	Title	Description
OG000	MP0420 Plus SOC	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Units	Counts
Participants	OG000

Secondary

Number of Participants With a Safety Outcome Through Day 28

Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28

Posted

Count of Participants

Participants

Through Day 28

ID	Title	Description
OG000	MP0420 Plus SOC	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Units	Counts
Participants	OG000

Secondary

Number of Participants With a Safety Outcome Through Day 90

Death, SAE, clinical organ failure, serious infections through Day 90

Posted

Count of Participants

Participants

Through Day 90

ID	Title	Description
OG000	MP0420 Plus SOC	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MP0420 Plus SOC	MP0420 600 mg solution (4 vials of 15 mg/mL); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion MP0420: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains. Remdesivir: Antiviral agent	30	247	14	247	65	247
EG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent	35	238	18	238	79	238

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0011 events1 affected238 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hemorrhoids	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Pancreatitis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Abdominal wall hematoma	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Injection site haematoma	General disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Gallbladder polyp	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Hypertransaminasemia	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Anastomotic ulcer	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Chilblains	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Thermal burn	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Hyperglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hodgkins's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Toxic encephalopathy	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Confusion state	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0012 events2 affected238 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Toe amputation	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0012 events2 affected238 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0002 events2 affected247 at risk EG0013 events3 affected238 at risk
Anemia of chronic disease	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0012 events2 affected238 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0004 events4 affected247 at risk EG0013 events3 affected238 at risk
Bradycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Cardiac arrest	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Mitral valve stenosis	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Right ventricular failure	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Sinus tachycardia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0012 events2 affected238 at risk
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0012 events1 affected238 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0012 events2 affected238 at risk
Hemorrhoids	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Pancreatitis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Abdominal wall hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0012 events2 affected238 at risk
Fatigue	General disorders	Non-systematic Assessment	EG00012 events11 affected247 at risk EG00115 events15 affected238 at risk
Generalized oedema	General disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Oedema	General disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0011 events1 affected238 at risk
Pain	General disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0003 events3 affected247 at risk EG0013 events3 affected238 at risk
Swelling face	General disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Non-cardiac chest pain	General disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0013 events3 affected238 at risk
Multiple organ dysfunction syndrome	General disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Cholecystitis acute	Hepatobiliary disorders	Non-systematic Assessment	EG0002 events1 affected247 at risk EG0010 events0 affected238 at risk
Ischemic hepatitis	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hypertransaminasemia	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0011 events1 affected238 at risk
Bacteraemia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0012 events2 affected238 at risk
Herpes zoster	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Mastoiditis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Otitis externa	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0012 events2 affected238 at risk
Pneumonia staphylococcal	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Pneumonia viral	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Sepsis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected247 at risk EG0013 events3 affected238 at risk
Sepsis shock	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0012 events2 affected238 at risk
Staphylococcal bacteremia	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected247 at risk EG0010 events0 affected238 at risk
Streptococcal bacteremia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Urinary tract infection bacterial	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Klebsiella sepsis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Staphylococcal infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Klebsiella bacteremia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Pneumonia bacterial	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0013 events3 affected238 at risk
Oral herpes	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Acinetobacter sepsis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
COVID-19 pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0012 events2 affected238 at risk
Acidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hyperglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 events3 affected247 at risk EG0014 events4 affected238 at risk
Hyperkalemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0012 events2 affected238 at risk
Hypervolemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected247 at risk EG0010 events0 affected238 at risk
Hyponatremia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Polydipsia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Decreased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0004 events4 affected247 at risk EG0013 events3 affected238 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hematoma muscle	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Cerebral ischaemia	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0011 events1 affected238 at risk
Loss of consciousness	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Ischemic stroke	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Intensive care unit acquired weakness	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Agitation	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Confusion state	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Delirium	Psychiatric disorders	Non-systematic Assessment	EG0002 events2 affected247 at risk EG0010 events0 affected238 at risk
Depressed mood	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Mental status changes	Psychiatric disorders	Non-systematic Assessment	EG0005 events5 affected247 at risk EG0017 events7 affected238 at risk
Polyuria	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Renal failure	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0011 events1 affected238 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0008 events7 affected247 at risk EG0017 events7 affected238 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected247 at risk EG0012 events2 affected238 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events4 affected247 at risk EG0017 events7 affected238 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0005 events5 affected247 at risk EG0015 events5 affected238 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00031 events27 affected247 at risk EG00127 events26 affected238 at risk
Dyspnea exertional	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0018 events8 affected238 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events1 affected247 at risk EG0013 events2 affected238 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0007 events7 affected247 at risk EG0014 events4 affected238 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events4 affected247 at risk EG0016 events4 affected238 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events2 affected247 at risk EG0016 events6 affected238 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0011 events1 affected238 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Organizing pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected247 at risk EG0010 events0 affected238 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hematoma	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0014 events4 affected238 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG00011 events10 affected247 at risk EG0018 events8 affected238 at risk
Hypovolemic shock	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected247 at risk EG0011 events1 affected238 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0004 events4 affected247 at risk EG0015 events4 affected238 at risk

ID	Term
D000086382	COVID-19
D003333	Coronaviridae Infections
D018352	Coronavirus Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D030341	Nidovirales Infections
D045169	Severe Acute Respiratory Syndrome

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C000715987	ensovibep
C000606551	remdesivir