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NCT04524507 · ClinicalTrials.gov registry record · Phase 2
Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT04524507: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT04524507 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04524507, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this research study is to find out if CCP is safe and to determine the safest and most effective level of anti-viral antibody when given to people admitted to the hospital with confirmed COVID-19 infection. Participants enrolled on this study will be transfused with 2 units of CCP through an IV. These units will be given one at a time 4 to 24 hours apart. Participants will be randomized to receive either 2 units with standard antibody levels as recommended by the FDA or 2 units with an antibody level higher than that recommended by the FDA. This study is experimental and CCP is investigational and has not been approved by the FDA for the treatment of COVID-19. The CCP is collected per FDA guidelines from persons recovered from COVID-19 infection. The plasma contains antibodies and possibly other properties that inhibit the virus. The investigators do not know if the level of antibodies present in the CCP will make a difference in how the participant's body is able to fight the infection and hope to learn that in this study.
Primary Outcome
Total number of SAE among all participants through Day 14; Definition of SAE per protocol and will only be included if related to COVID-19 Convalescent Plasma (CCP): 1. Death; 2. Life-threatening (immediate risk of death); 3. Prolongation of existing hospitalization; 4. Persistent or significant disability or incapacity; OR 5. Important medical events that may not result in death, be life threatening, or require intervention or escalation of care may be considered a serious adverse event when, b
Interventions
- BIOLOGICAL High-titer Convalescent COVID-19 Plasma (CCP1)
- BIOLOGICAL Standard-titer Convalescent COVID-19 plasma (CCP2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-08-27 |
| Est. Completion | 2021-06-04 |
| Phase | Phase 2 |
What the finished NCT04524507 record still lists
NCT04524507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which High-titer Convalescent COVID-19 Plasma (CCP1) is the first listed.
NCT04524507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04524507 about?
NCT04524507 is a clinical study titled "Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients". The purpose of this research study is to find out if CCP is safe and to determine the safest and most effective level of anti-viral antibody when given to people admitted to the hospital with confirmed COVID-19 infection. Participants enrolled on this study will be transfused with 2 units of CCP thr...
What is the current status of trial NCT04524507?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2020-08-27. Estimated completion is 2021-06-04.
What interventions are being tested in trial NCT04524507?
The interventions under investigation include: High-titer Convalescent COVID-19 Plasma (CCP1) (BIOLOGICAL), Standard-titer Convalescent COVID-19 plasma (CCP2) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04524507?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04524507's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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