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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 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04524507
The ClinicalTrials.gov registry entry for NCT04524507 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which High-titer Convalescent COVID-19 Plasma (CCP1) is the first listed.
NCT04524507 reports 0 study locations.
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.
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