Intramuscular and Intravenous VIR-7831 (Sotrovimab) for Mild/Moderate COVID-19.
Public ClinicalTrials.gov record NCT04913675. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients; Safety Substudy Assessing the Safety and Tolerability of Single Ascending Dose Monoclonal Antibody VIR-7831
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The COMET-TAIL main study evaluated efficacy, safety, and tolerability of IM sotrovimab versus IV sotrovimab in high-risk patients for the treatment of mild/moderate COVID-19. In the safety substudy, the aim was to evaluate the safety and tolerability of sotrovimab across a single ascending dose level and over different infusion times when given for the treatment of mild/moderate COVID-19 to participants at high risk of disease progression Main study was completed successfully. The safety sub-study was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.
Study identification
- NCT ID
- NCT04913675
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,065 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 9, 2021
- Primary completion
- Jul 18, 2022
- Completion
- Mar 23, 2023
- Last update posted
- Mar 6, 2024
2021 – 2023
United States locations
- U.S. sites
- 48
- U.S. states
- 15
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigative Site | Anniston | Alabama | 36207 | — |
| Investigative Site | Mesa | Arizona | 85210 | — |
| Investigative Site | Tucson | Arizona | 85712 | — |
| Investigative Site | Los Angeles | California | 90017 | — |
| Investigative Site | Rolling Hills Estates | California | 90274 | — |
| Investigative Site | Bradenton | Florida | 34208 | — |
| Investigative Site | Doral | Florida | 33126 | — |
| Investigative Site | Doral | Florida | 33166 | — |
| Investigative Site | Gainesville | Florida | 32607 | — |
| Investigative Site | Hialeah | Florida | 33012 | — |
| Investigative Site | Hialeah | Florida | 33013 | — |
| Investigative Site | Hialeah | Florida | 33016 | — |
| Investigative Site | Miami | Florida | 33032 | — |
| Investigative Site | Miami | Florida | 33125 | — |
| Investigative Site | Miami | Florida | 33126 | — |
| Investigative Site | Miami | Florida | 33135 | — |
| Investigative Site | Miami | Florida | 33144 | — |
| Investigative Site | Miami | Florida | 33155 | — |
| Investigative Site | Miami | Florida | 33175 | — |
| Investigative Site | Miami | Florida | 33176 | — |
| Investigative Site | Miami | Florida | 33180 | — |
| Investigative Site | North Miami Beach | Florida | 33169 | — |
| Investigative Site | Ormond Beach | Florida | 32174 | — |
| Investigative Site | Palmetto Bay | Florida | 33157 | — |
| Investigative Sites | Pembroke Pines | Florida | 33024 | — |
| Investigative Site | Pompano Beach | Florida | 33064 | — |
| Investigative Site | Tampa | Florida | 33614 | — |
| Investigative Site | Tampa | Florida | 33615 | — |
| Investigative Site | Atlanta | Georgia | 30318 | — |
| Investigative Site | Idaho Falls | Idaho | 83404 | — |
| Investigative Site | Mishawaka | Indiana | 46544 | — |
| Investigative Site | Sterling Heights | Michigan | 48126 | — |
| Investigative Site | Las Vegas | Nevada | 89113 | — |
| Investigative Site | The Bronx | New York | 10456 | — |
| Investigative Site | High Point | North Carolina | 27262 | — |
| Investigative Site | Mount Airy | North Carolina | 27030 | — |
| Investigative Site | Columbus | Ohio | 43215 | — |
| Investigative Site | Smithfield | Pennsylvania | 15478 | — |
| Investigative Site | Baytown | Texas | 77521 | — |
| Investigative Site | Forney | Texas | 75126 | — |
| Investigative Site | Houston | Texas | 77017 | — |
| Investigative Site | Houston | Texas | 77024 | — |
| Investigative Site | Houston | Texas | 77090 | — |
| Investigative Site | Laredo | Texas | 78041 | — |
| Investigative Site | Mesquite | Texas | 75149 | — |
| Investigative Site | Pharr | Texas | 78577 | — |
| Investigative Site | Kirkland | Washington | 98034 | — |
| Investigative Site | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04913675, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 6, 2024 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04913675 live on ClinicalTrials.gov.