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NCT04355897 · ClinicalTrials.gov registry record · Early Phase 1
CoVID-19 Plasma in Treatment of COVID-19 Patients
A Early Phase 1 study, sponsored by The Christ Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
NCT04355897: Completed Early Phase 1 study, sponsored by The Christ Hospital.
NCT04355897 is a Early Phase 1 study that has completed, run by The Christ Hospital. The registered enrollment target is 22 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04355897, a Early Phase 1 study, has completed, sponsored by The Christ Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The investigatores propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease as reflected by the presence of elevated hsTPN. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illness. Investigators hypothesize that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality and a key secondary objective to reduce the requirement for and/or duration of mechanical ventilation. Finally, as the hospital mortality for patients requiring mechanical ventilation is very high (50 to 80%), these patients will be eligible for COVID19 CP treatment as well, even in the absence of elevated hsTPN. Although considerable overlap of these populations has been observed (elevated hsTPN and requirement for mechanical ventilation) there is not 100% redundancy and it is hopeful that COVID19 CP may provide benefit to these critically ill patients.
Primary Outcome
Reduce mortality of high risk COVID 19 disease compared with historic precedent cohorts (35-50%)
Interventions
- BIOLOGICAL Convalescent COVID 19 Plasma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-04-28 |
| Est. Completion | 2020-08-12 |
| Phase | Early Phase 1 |
What the finished NCT04355897 record still lists
NCT04355897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Convalescent COVID 19 Plasma is the first listed.
NCT04355897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04355897 about?
NCT04355897 is a clinical study titled "CoVID-19 Plasma in Treatment of COVID-19 Patients". The investigatores propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in patients requiring hospitalization for symptomatic "high risk" COVID19 disease as reflected by the presence of elevated hsTPN. Supportive data exist for use of convalescen...
What is the current status of trial NCT04355897?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2020-04-28. Estimated completion is 2020-08-12.
What interventions are being tested in trial NCT04355897?
The interventions under investigation include: Convalescent COVID 19 Plasma (BIOLOGICAL).
Who is sponsoring clinical trial NCT04355897?
This trial is sponsored by The Christ Hospital, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04355897's enrollment target sits among peer trials
22 1104th of 2000 higher than 872 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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