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NCT04362176 · ClinicalTrials.gov registry record · Phase 3
Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults
A Phase 3 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 974
- Enrollment target
NCT04362176: Completed Phase 3 study, sponsored by Vanderbilt University Medical Center.
NCT04362176 is a Phase 3 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 974 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04362176, a Phase 3 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 974 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordinal Clinical Progression Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
Primary Outcome
Outcome measured clinical status of the participant defined by the Covid-19 7-point Ordinal Clinical Progression Outcomes Scale: This scale reflects a range from baseline to death as follows: 1. Not hospitalized with resumption of normal activities. 2. Not hospitalized, but unable to resume normal activities. 3. Hospitalized, not on supplemental oxygen. 4. Hospitalized, on supplemental oxygen. 5. Hospitalized, on nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both 6. Hos
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL pathogen reduced SARS-CoV-2 convalescent plasma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 974 participants |
| Start Date | 2020-04-24 |
| Est. Completion | 2021-08-06 |
| Phase | Phase 3 |
What the finished NCT04362176 record still lists
NCT04362176 is an interventional study that assigns participants to a tested intervention. The registered 974 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04362176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04362176 about?
NCT04362176 is a clinical study titled "Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults". The purpose of this study is to test the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting. The effect of convalescent plasma will be compared to placebo on clinical outcomes, measured using the COVID-19 7-point Ordi...
What is the current status of trial NCT04362176?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 974 participants. The study started on 2020-04-24. Estimated completion is 2021-08-06.
What interventions are being tested in trial NCT04362176?
The interventions under investigation include: Placebo (BIOLOGICAL), pathogen reduced SARS-CoV-2 convalescent plasma (BIOLOGICAL).
Who is sponsoring clinical trial NCT04362176?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04362176's enrollment target sits among peer trials
974 328th of 2000 higher than 1,672 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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