Trial Outcomes & Findings for VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) (NCT NCT05780281)

Last Updated: 2023-12-27

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

367 participants

Primary outcome timeframe

Through Day 90

Results posted on

2023-12-27

Participant Flow

Subjects were enrolled from 43 sites in 4 countries (Denmark, Switzerland, Poland, USA). The first subject was enrolled on 16 Dec 2020 and the last subject was enrolled on 1 Mar 2021. The list of sites provided in the Contacts/Locations section includes all sites for all sub-studies under the master protocol (NCT04501978).

Of 363 subjects enrolled, 360 received all or part of their assigned treatment.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	184	183
Overall Study COMPLETED	182	178
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VIR-7831 Plus SOC n=182 Participants * 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	Placebo Plus SOC n=178 Participants * 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	Total n=360 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 15.8 • n=93 Participants	59.5 years STANDARD_DEVIATION 14.7 • n=4 Participants	60.2 years STANDARD_DEVIATION 15.3 • n=27 Participants
Sex: Female, Male Female	75 Participants n=93 Participants	75 Participants n=4 Participants	150 Participants n=27 Participants
Sex: Female, Male Male	107 Participants n=93 Participants	103 Participants n=4 Participants	210 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=93 Participants	32 Participants n=4 Participants	62 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	152 Participants n=93 Participants	146 Participants n=4 Participants	298 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Asian	7 Participants n=93 Participants	9 Participants n=4 Participants	16 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	40 Participants n=93 Participants	37 Participants n=4 Participants	77 Participants n=27 Participants
Race/Ethnicity, Customized White	117 Participants n=93 Participants	109 Participants n=4 Participants	226 Participants n=27 Participants
Race/Ethnicity, Customized Other	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Only ethnicity reported	13 Participants n=93 Participants	15 Participants n=4 Participants	28 Participants n=27 Participants

PRIMARY outcome

Timeframe: Through Day 90

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

Outcome measures

Outcome measures
Measure	VIR-7831 Plus SOC n=182 Participants * 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	Placebo Plus SOC n=178 Participants * 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
Number of Participants With Sustained Recovery	160 Participants	151 Participants

PRIMARY outcome

Timeframe: Status on Day 5

Ordinal outcome with 7 mutually exclusive categories

Outcome measures

Outcome measures
Measure	VIR-7831 Plus SOC n=181 Participants * 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	Placebo Plus SOC n=178 Participants * 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
Number of Participants With an Ordinal Outcome on Day 5 7 = Death	0 Participants	1 Participants
Number of Participants With an Ordinal Outcome on Day 5 5 = Non-invasive ventilation or high flow oxygen	10 Participants	14 Participants
Number of Participants With an Ordinal Outcome on Day 5 4 = Supplement oxygen (≥4 L/min or ≥4 L/min above baseline, but not high flow oxygen)	19 Participants	20 Participants
Number of Participants With an Ordinal Outcome on Day 5 6 = Invasive ventilation, ECMO, mechanical circulatory support, new renal replacement therapy	2 Participants	3 Participants
Number of Participants With an Ordinal Outcome on Day 5 3 = Supplement oxygen (<4 L/min or <4 L/min above baseline, but not high flow oxygen)	42 Participants	42 Participants
Number of Participants With an Ordinal Outcome on Day 5 2 = Limiting symptoms due to COVID-19, but not need of new or increased oxygen from baseline	66 Participants	58 Participants
Number of Participants With an Ordinal Outcome on Day 5 1 = No limiting symptoms due to COVID-19	42 Participants	40 Participants

SECONDARY outcome

Timeframe: Through Day 90

All-cause mortality

Outcome measures

Outcome measures
Measure	VIR-7831 Plus SOC n=182 Participants * 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	Placebo Plus SOC n=178 Participants * 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
Number of Participants Who Died From All Causes	14 Participants	13 Participants

SECONDARY outcome

Timeframe: Through Day 5

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

Outcome measures

Outcome measures
Measure	VIR-7831 Plus SOC n=182 Participants * 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	Placebo Plus SOC n=178 Participants * 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
Number of Participants With a Safety Outcome Through Day 5	36 Participants	44 Participants

SECONDARY outcome

Timeframe: Through Day 28

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

Outcome measures

Outcome measures
Measure	VIR-7831 Plus SOC n=182 Participants * 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	Placebo Plus SOC n=178 Participants * 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
Number of Participants With a Safety Outcome Through Day 28	51 Participants	58 Participants

SECONDARY outcome

Timeframe: Through Day 90

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

Outcome measures

Outcome measures
Measure	VIR-7831 Plus SOC n=182 Participants * 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	Placebo Plus SOC n=178 Participants * 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
Number of Participants With a Safety Outcome Through Day 90	42 Participants	48 Participants

Adverse Events

VIR-7831 Plus SOC

Serious events: 10 serious events

Other events: 39 other events

Deaths: 14 deaths

Placebo Plus SOC

Serious events: 12 serious events

Other events: 41 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Additional Information

Greg Grandits

University of Minnesota

Phone: 651-528-9491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	VIR-7831 Plus SOC n=182 participants at risk * 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	Placebo Plus SOC n=178 participants at risk * 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
Blood and lymphatic system disorders Hemolytic anemia	0.55% 1/182 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.	0.00% 0/178 • 90 days Only Grade 3 or 4 AEs were collected.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.55% 1/182 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.	0.00% 0/178 • 90 days Only Grade 3 or 4 AEs were collected.
Immune system disorders Anaphylactic reaction	0.55% 1/182 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.	0.00% 0/178 • 90 days Only Grade 3 or 4 AEs were collected.
Immune system disorders Cytokine release syndrome	0.55% 1/182 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.	0.00% 0/178 • 90 days Only Grade 3 or 4 AEs were collected.
Infections and infestations COVID-19 pneumonia	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Investigations Transaminases increased	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Investigations Hepatic enzyme increased	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Metabolism and nutrition disorders Dehydration	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Metabolism and nutrition disorders Hypercalcemia	0.55% 1/182 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.	0.00% 0/178 • 90 days Only Grade 3 or 4 AEs were collected.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Nervous system disorders Presyncope	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Nervous system disorders Syncope	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Psychiatric disorders Suicidal ideation	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Renal and urinary disorders Nephrolithiasis	0.55% 1/182 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.	0.00% 0/178 • 90 days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 2/182 • Number of events 2 • 90 days Only Grade 3 or 4 AEs were collected.	0.00% 0/178 • 90 days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.55% 1/182 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.	0.00% 0/178 • 90 days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.55% 1/182 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.	0.00% 0/178 • 90 days Only Grade 3 or 4 AEs were collected.
Respiratory, thoracic and mediastinal disorders Organizing pneumonia	0.00% 0/182 • 90 days Only Grade 3 or 4 AEs were collected.	0.56% 1/178 • Number of events 1 • 90 days Only Grade 3 or 4 AEs were collected.