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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 is a Early Phase 1 study that has completed, run by The Christ Hospital. The registered enrollment target is 22 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04355897
The ClinicalTrials.gov registry entry for NCT04355897 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Christ Hospital, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Convalescent COVID 19 Plasma is the first listed.
NCT04355897 reports 0 study locations.
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.
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