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NCT04361253 · ClinicalTrials.gov registry record · Phase 3
Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy
A Phase 3 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
NCT04361253: Clinical Trial Phase 3 study, sponsored by Brigham and Women's Hospital.
NCT04361253 is a Phase 3 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 45 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04361253, a Phase 3 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
Study Summary
In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.
Primary Outcome
The primary outcome will be the MOS numerical score (score 0-9) where a score of 0 attributes to 'no clinical evidence of infection' and a score of 9 attributes to 'death'. The eligibility requirements for this trial select individuals at level 3 or higher on the modified scale, but the day 14 outcome can be any one of 10 levels.
Interventions
- BIOLOGICAL High-Titer COVID-19 Convalescent Plasma (HT-CCP)
- BIOLOGICAL Standard Plasma (FFP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-04-30 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 3 |
Why NCT04361253 stopped before completion
NCT04361253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which High-Titer COVID-19 Convalescent Plasma (HT-CCP) is the first listed.
NCT04361253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04361253 about?
NCT04361253 is a clinical study titled "Evaluation of SARS-CoV-2 (COVID-19) Antibody-containing Plasma thErapy". In this study, investigators will determine whether the early addition of HT-CCP to standard treatment improves the clinical outcome (as assessed by the Modified WHO Ordinal Scale) of patients with COVID-19 who are hospitalized but not yet in moderate or severe ARDS.
What is the current status of trial NCT04361253?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2020-04-30. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT04361253?
The interventions under investigation include: High-Titer COVID-19 Convalescent Plasma (HT-CCP) (BIOLOGICAL), Standard Plasma (FFP) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04361253?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04361253's enrollment target sits among peer trials
45 1870th of 2000 higher than 127 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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