Study Summary
This trial is testing a new antibody drug to see if it is effective and safe for treating mild to moderate COVID-19 in non-hospitalized high-risk patients. There is also a safety substudy to assess the safety and tolerability of a single dose of the drug.
Eligible Conditions
- Coronavirus
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 50 Secondary · Reporting Duration: up to Week 36
Day 29
Intramuscular serum concentration (IM) in Main Study
Intravenous serum concentration (IV) in Main Study
Up to 24 Weeks
Serum concentration at end of intravenous infusion (IV)
Up to 24 weeks
Incidence (if applicable) of serum anti-drug antibody (ADA) to sotrovimab
Incidence (if applicable) of serum anti-drug antibody (ADA) to sotrovimab in Main Study
Occurence of of adverse events (AEs)
Occurence of of adverse events (AEs) In Main Study
Occurrence of adverse events of special interest (AESI)
Occurrence of adverse events of special interest (AESI) in Main Study
Disease
Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs) in Main Study
Progression of COVID-19 in Main Study
Titers (if applicable) of serum anti-drug antibody (ADA) to sotrovimab
Titers (if applicable) of serum anti-drug antibody (ADA) to sotrovimab in Main Study
Up to Day 29
Proportion of participants who have progression of COVID-19
Proportion of participants who progress to develop severe and/or critical respiratory corona virus disease- 2019 (COVID-19) as manifest by requirement for and method of supplemental oxygen
Up to Day 8
Change from baseline in viral load by quantitative reverse transcription- polymerase chain reaction (qRT-PCR)
Change from baseline in viral load by quantitative reverse transcription- polymerase chain reaction (qRT-PCR) in Main Study
Coronaviridae
Mean area under the curve of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) viral load in nasal secretions as measured by qRT-PCR in Main Study
Proportion of participants with a persistently high SARS-CoV-2 viral load at Day 8 by qRT-PCR
Proportion of participants with a persistently high SARS-CoV-2 viral load at Day 8 by qRT-PCR in Main Study
at Day 29
Intramuscular serum concentration (IM)
Intravenous serum concentration (IV)
up to 24 weeks
%AUCextrap (intramuscular injection)
%AUCextrap (intravenous infusion)
AUCinf (intramuscular injection)
AUCinf (intravenous infusion)
AUClast (intramuscular injection)
AUClast (intravenous infusion)
CL/F (intramuscular injection)
CL/F (intravenous infusion)
Clast (intramuscular injection)
Clast (intravenous infusion)
Cmax (intramuscular injection)
Cmax (intravenous infusion)
Intramuscular injection
Tlast (intravenous infusion)
Tmax (intramuscular injection)
Tmax (intravenous infusion)
Vz/F (intramuscular injection)
Vz/F (intravenous infusion)
t1/2 (intramuscular injection)
t1/2 (intravenous infusion)
up to Week 12
Occurrence of adverse events (AEs) in Safety Sub-study
Occurrence of adverse events of special interest (AESIs) in Safety Sub-study
Occurrence of disease related events (DREs) in Safety Sub-study
up to Week 24
Incidence and titers (if applicable) of serum anti-drug antibody (ADA) and neutralizing antibody (if applicable) to sotrovimab in Safety Sub-study
Intravenous serum concentration (IV) in Safety Sub-Study
up to Week 36
Occurrence of serious adverse events (SAEs) in Safety Sub-study
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
5 Treatment Groups
VIR-7831 (Sotrovimab) 500mg IV
1 of 5
VIR-7831 (Sotrovimab) 500mg IM
1 of 5
VIR-7831 (Sotrovimab)
1 of 5
VIR-7831 (Sotrovimab) 250mg IM
1 of 5
Safety Substudy VIR 7831 (Sotrovimab)
1 of 5
Active Control
Experimental Treatment
1200 Total Participants · 5 Treatment Groups
Primary Treatment: VIR-7831 sotrovimab · No Placebo Group · Phase 3
VIR-7831 (Sotrovimab) 500mg IM
Biological
Experimental Group · 1 Intervention: VIR-7831 · Intervention Types: BiologicalVIR-7831 (Sotrovimab)
Biological
Experimental Group · 1 Intervention: VIR-7831 sotrovimab · Intervention Types: BiologicalVIR-7831 (Sotrovimab) 250mg IM
Biological
Experimental Group · 1 Intervention: VIR-7831 · Intervention Types: BiologicalSafety Substudy VIR 7831 (Sotrovimab)
Biological
Experimental Group · 1 Intervention: VIR-7831 · Intervention Types: BiologicalVIR-7831 (Sotrovimab) 500mg IV
Biological
ActiveComparator Group · 1 Intervention: VIR-7831 · Intervention Types: BiologicalTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotrovimab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 36
Who is running the clinical trial?
Vir Biotechnology, Inc.Lead Sponsor
23 Previous Clinical Trials
11,733 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,648 Previous Clinical Trials
7,944,752 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You 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 7 days from onset of symptoms.
Who else is applying?
What state do they live in?
| Florida | 40.0% |
| Texas | 40.0% |
| North Carolina | 20.0% |
How old are they?
| 65+ | 25.0% |
| 18 - 65 | 75.0% |
What site did they apply to?
| Investigative Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 50.0% |
| Met criteria | 50.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
References
- Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.
- Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- 2021. "Intramuscular VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19. Substudy: Intravenous Single Ascending Dose VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04913675.
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Conditions
Cancer Related
Treatments