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NCT04432272 · ClinicalTrials.gov registry record · Phase 2
ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)
A Phase 2 study, sponsored by Corewell Health East.
- Terminated
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT04432272 is a Phase 2 study that was terminated before completion, run by Corewell Health East. The registered enrollment target is 71 participants.
The verdict
NCT04432272, a Phase 2 study, was terminated before completion, sponsored by Corewell Health East.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90 (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected with COVID-19 and recovered. The use of this blood product to treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not yet approved it to be sold commercially. This is a human blood product collected by licensed blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor criteria and must also meet all criteria set by the FDA for being a donor of COVID-19 convalescent plasma. A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar studies are being done at other centers, but they are not directly related to this study. Participants will be assigned to a study group depending on how sick they are. * Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on a ventilator * Group B: Those who require a ventilator to preserve their life. Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood samples will be taken prior to and one hour after the transfusion to measure participant antibodies against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) and a nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure antibody levels to determine if the plasma caused the antibody level to rise. Similarly, blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after the transfusion while the part
Interventions
- BIOLOGICAL COVID-19 convalescent plasma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2020-07-16 |
| Est. Completion | 2020-11-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04432272
The ClinicalTrials.gov registry entry for NCT04432272 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corewell Health East, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which COVID-19 convalescent plasma is the first listed.
NCT04432272 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04432272 about?
NCT04432272 is a clinical study titled "ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)". The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90 (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of blood that is left when all the blood cells have been removed. Convalescent means it is taken from people who were infected ...
What is the current status of trial NCT04432272?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2020-07-16. Estimated completion is 2020-11-28.
What interventions are being tested in trial NCT04432272?
The interventions under investigation include: COVID-19 convalescent plasma (BIOLOGICAL).
Who is sponsoring clinical trial NCT04432272?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
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