VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Tr... | NCT05780281

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 VIR-7831 in hospitalized patients infected with COVID-19.

This is a randomized, blinded, controlled sub-study of VIR-7831 plus current standard of care (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 VIR-7831 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
VIR-7831 plus SOC	Experimental	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion	Biological: VIR-7831 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	Biological: Placebo Biological: Remdesivir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VIR-7831	Biological	VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1.	VIR-7831 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
34928698	Result	ACTIV-3/TICO Bamlanivimab Study Group; Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U, Brown SM, Knowlton KU, Self WH, Files DC, Jain MK, Benfield T, Bowdish ME, Leshnower BG, Baker JV, Jensen JU, Gardner EM, Ginde AA, Harris ES, Johansen IS, Markowitz N, Matthay MA, Ostergaard L, Chang CC, Goodman AL, Chang W, Dewar RL, Gerry NP, Higgs ES, Highbarger H, Murray DD, Murray TA, Natarajan V, Paredes R, Parmar MKB, Phillips AN, Reilly C, Rupert AW, Sharma S, Shaw-Saliba K, Sherman BT, Teitelbaum M, Wentworth D, Cao H, Klekotka P, Babiker AG, Davey VJ, Gelijns AC, Kan VL, Polizzotto MN, Thompson BT, Lane HC, Neaton JD. Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial. Ann Intern Med. 2022 Feb;175(2):234-243. doi: 10.7326/M21-3507. Epub 2021 Dec 21.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	VIR-7831 Plus SOC	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. 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 H2 Protocol	Nov 20, 2020

Arm/Group Information

ID	Title	Description
BG000	VIR-7831 Plus SOC	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. 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
	BG00061.0± 15.8 BG00159.5± 14.7 BG00260.2± 15.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00075 BG00175 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00030 BG00132 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG0007 BG0019 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	VIR-7831 Plus SOC	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. 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	OG000182 OG001178

Title

Denominators

Categories

Title	Measurements
	OG000160 OG001151

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	VIR-7831 Plus SOC	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. 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	VIR-7831 Plus SOC	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. 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	VIR-7831 Plus SOC	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. 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

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	VIR-7831 Plus SOC	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. 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

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	VIR-7831 Plus SOC	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. 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	VIR-7831 Plus SOC	VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831: VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1. Remdesivir: Antiviral agent	14	182	10	182	39	182
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	13	178	12	178	41	178

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hemolytic anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Anaphylactic reaction	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Cytokine release syndrome	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
COVID-19 pneumonia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Transaminases increased	Investigations	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Hepatic enzyme increased	Investigations	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Hypercalcemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Hyperglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Presyncope	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Suicidal ideation	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Nephrolithiasis	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected182 at risk EG0010 events0 affected178 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Organizing pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hemolytic anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Iron deficiency anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Pancytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Angina pectoris	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Arrhythmia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Atrial flutter	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Bradycardia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0011 events1 affected178 at risk
Cardio-respiratory arrest	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Cardiogenic shock	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Pericardial effusion	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0011 events1 affected178 at risk
Retroperitoneal hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0011 events1 affected178 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Fatigue	General disorders	Non-systematic Assessment	EG0004 events4 affected182 at risk EG0016 events6 affected178 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0012 events2 affected178 at risk
Hepatitis	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Clostridium difficile colitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Gastroenteritis viral	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0012 events1 affected178 at risk
Pneumonia staphylococcal	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Septic shock	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected182 at risk EG0010 events0 affected178 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0013 events3 affected178 at risk
Pneumonia bacterial	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0011 events1 affected178 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Blood glucose increased	Investigations	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Diabetes mellitus	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Hyperglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0012 events2 affected178 at risk
Hypernatremia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Hypoglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Decreased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Back Pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0011 events1 affected178 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0012 events1 affected178 at risk
Ageusia	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Anosmia	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Cerebrovascular accident	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0011 events1 affected178 at risk
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Delirium	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0014 events4 affected178 at risk
Mental status changes	Psychiatric disorders	Non-systematic Assessment	EG0005 events5 affected182 at risk EG0013 events3 affected178 at risk
Anxiety disorder	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0003 events3 affected182 at risk EG0010 events0 affected178 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0011 events1 affected178 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events4 affected182 at risk EG0014 events3 affected178 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00013 events10 affected182 at risk EG00115 events13 affected178 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0008 events7 affected182 at risk EG0018 events6 affected178 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events1 affected182 at risk EG0011 events1 affected178 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0012 events2 affected178 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG0007 events6 affected182 at risk EG0013 events3 affected178 at risk
Hypovolemic shock	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Orthostatic hypotension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Shock	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected182 at risk EG0011 events1 affected178 at risk
Thrombosis	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0011 events1 affected178 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 at risk
Superficial vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected182 at risk EG0010 events0 affected178 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
C000711967	sotrovimab
C000606551	remdesivir