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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: Clinical Trial Phase 2 study, sponsored by Corewell Health East.
NCT04432272 is a Phase 2 study that was terminated before completion, run by Corewell Health East. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Count of group A participants (non-intubated participants requiring \>6 L supplemental oxygen to maintain oxygen saturation \>92% at time of study entry and who are admitted \<14 days) who remain un-intubated
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 |
Why NCT04432272 stopped before completion
NCT04432272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which COVID-19 convalescent plasma is the first listed.
NCT04432272 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04432272's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 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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