Phase 3
Completed N=1,057
VIR-7831 for the Early Treatment of COVID-19 in Outpatients
Covid19
Source: ClinicalTrials.gov NCT04545060 ↗
Enrolled (actual)
1,057
Serious AEs
4.4%
Results posted
Nov 2022
Primary outcomePrimary: Number of Participants Who Had Progression of COVID-19 Through Day 29 — 6; 30 Participants — p=<0.001
◆ Published Evidence
Highly cited
1,083citations · ~217 / year
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab.
Summary
This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics.
Linked Publications (5)
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Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab.
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Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial.
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Antibody therapy reverses biological signatures of COVID-19 progression.
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Resistance analysis following sotrovimab treatment in participants with COVID-19 during the phase III COMET-ICE study.
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Assessment of symptoms in COMET-ICE, a phase 2/3 study of sotrovimab for early treatment of non-hospitalized patients with COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Progression of COVID-19 Through Day 29 |
6; 30 | <0.001 sig |
| SECONDARY Number of Participants With Adverse Events (AEs) |
133; 140 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
11; 35 | — |
| SECONDARY Number of Participants With Infusion-related Reactions (IRR) Including Hypersensitivity Reactions |
7; 6 | — |
| SECONDARY Number of Participants With Cardiac Events of Special Interest |
1; 0 | — |
| SECONDARY Number of Participants With Serum Anti-drug Antibody (ADA) to Sotrovimab |
65; 0 | — |
| SECONDARY Titers of Serum Anti-drug Antibody (ADA) to Sotrovimab |
40; 0; 80; 0; 10; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of VIR-7831 After IV Administration |
245.6 | — |
| SECONDARY Concentration at the Last Quantifiable Time Point (Clast) of VIR-7831 After IV Administration |
8.4 | — |
| SECONDARY Time to Reach the Maximum Concentration (Tmax) of VIR-7831 After IV Administration |
0.04 | — |
| SECONDARY Time of the Last Quantifiable Concentration (Tlast) of VIR-7831 After IV Administration |
161 | — |
| SECONDARY Area Under the Serum Concentration-time Curve Extrapolated From Zero to Infinity (AUCinf) of VIR-7831 After IV Administration |
5536.9 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From the Time of Dosing to the Time of the Last Measurable (Positive) Concentration (AUClast) of VIR-7831 After IV Administration |
4777.7 | — |
| SECONDARY Percentage of AUCinf Obtained by Extrapolation (%AUCexp) for VIR-7831 After IV Administration |
12.6 | — |
| SECONDARY Terminal Elimination Half-life (t1/2) of VIR-7831 After IV Administration |
56.5 | — |
| SECONDARY Apparent Volume of Distribution During the Elimination Phase (Vz) of VIR-7831 Following IV Administration |
7.52 | — |
| SECONDARY Apparent Volume of Distribution at Steady State (Vss) of VIR-7831 Following IV Administration |
6.93 | — |
| SECONDARY Clearance (CL) of VIR-7831 After IV Administration |
90.3 | — |
| SECONDARY Number of Participants Who Had Progression of COVID-19 |
13; 39 | <0.001 sig |
| SECONDARY Mean Change in FLU PRO Plus Total Score (AUC) |
-3.05; -1.98 | <0.001 sig |
| SECONDARY Time to Symptom Alleviation Using FLU-PRO Plus |
NA; NA | — |
| SECONDARY Change From Baseline in Viral Load in Nasal Secretions by qRT-PCR at Day 8 |
-2.589; -2.357 | 0.007 sig |
| SECONDARY Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 8 |
6; 20 | — |
| SECONDARY Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 15 |
6; 28 | — |
| SECONDARY Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 22 |
7; 28 | — |
| SECONDARY Number of Participants Who Progressed to Develop Severe and/or Critical Respiratory COVID-19 as Manifested by Requirement for and Method of Supplemental Oxygen Through Day 29 |
7; 28 | 0.002 sig |
| SECONDARY 29-day All-cause Mortality |
0; 2 | — |
| SECONDARY 60-day All-cause Mortality |
0; 4 | — |
| SECONDARY 90-day All-cause Mortality |
0; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Participant must be aged 18 years or older AND at high risk of progression of COVID-19 or ≥ 55 years old
- Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms
Exclusion Criteria
- Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours
- Symptoms consistent with severe COVID-19
- Participants who, in the judgement of the investigator are likely to die in the next 7 days
- Severely immunocompromised participants
Data sourced from ClinicalTrials.gov (NCT04545060) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.