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NCT04779879 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19
A Phase 2 study of COVID-19, sponsored by Vir Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 354
- Enrollment target
- 20
- Study locations
NCT04779879: Completed Phase 2 study of COVID-19, sponsored by Vir Biotechnology.
NCT04779879 is a Phase 2 study of COVID-19 that has completed, run by Vir Biotechnology. The registered enrollment target is 354 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04779879, a Phase 2 study of COVID-19, has completed, sponsored by Vir Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 354 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, signifi
Conditions Studied
Interventions
- BIOLOGICAL Sotrovimab (Gen1)
- BIOLOGICAL Sotrovimab (Gen2)
Study Locations (20)
Florida
- Investigative Site - Ft. Pierce
- Investigative Site - Gainesville
- Investigative Site - Hialeah
- Investigative Site - Miami
- Investigative Site - Miami
- Investigative Site - Miami
- Investigative Site - Miami
- Investigative Site - Orlando
- Investigative Site - Pembroke Pines
- Investigative Site - Tampa
California
- Investigative Site - Bakersfield
- Investigative Site - Northridge
Ontario
- Investigative Site - Sarnia
- Investigative Site - Toronto
Alabama
- Investigative Site - Anniston
Georgia
- Investigative Site - Columbus
Illinois
- Investigative Site - Winfield
Maryland
- Investigative Site - Rockville
New York
- Investigative Site - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2021-02-18 |
| Est. Completion | 2022-04-06 |
| Phase | Phase 2 |
What the finished NCT04779879 record still lists
NCT04779879 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Sotrovimab (Gen1) is the first listed.
NCT04779879 names 20 study sites across 9 states, led by Florida, California, Ontario.
Frequently Asked Questions
What is clinical trial NCT04779879 about?
NCT04779879 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Second Generation VIR-7831 Material in Non-hospitalized Participants With Mild to Moderate COVID-19". This is a phase 2 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 (Sotrovimab) Generation 1 (Gen1) or VIR-7831 (Sotrovimab) Generation 2 (Gen2) and will be assessed for safety, tolerability, and pharmacokinetics.
What is the current status of trial NCT04779879?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 354 participants. The study started on 2021-02-18. Estimated completion is 2022-04-06.
What conditions does trial NCT04779879 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04779879?
The interventions under investigation include: Sotrovimab (Gen1) (BIOLOGICAL), Sotrovimab (Gen2) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04779879?
This trial is sponsored by Vir Biotechnology, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04779879 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04779879's enrollment target sits among peer trials
354 132nd of 298 higher than 167 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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