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NCT04376034 · ClinicalTrials.gov registry record · Phase 3
Convalescent Plasma Collection and Treatment in Pediatrics and Adults
A Phase 3 study of COVID-19 and Corona Virus Infection, sponsored by West Virginia University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT04376034: Recruiting Phase 3 study of COVID-19 and Corona Virus Infection, sponsored by West Virginia University.
NCT04376034 is a Phase 3 study of COVID-19 and Corona Virus Infection that is actively recruiting participants, run by West Virginia University. The registered enrollment target is 240 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04376034, a Phase 3 study of COVID-19 and Corona Virus Infection, is actively recruiting participants, sponsored by West Virginia University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors. There are 3 basic arms to the study: mild, moderate and severe/critical severity. All 3 severity groups are eligible for enrollment, but mild severity will not be given plasma unless there is progression. Moderate severity will given up to 1 unit of plasma and severe/critical severity up to 2 units. There is no placebo group, however given the excepted issues of shortages of plasma, intention to treat will be used for analysis.
Primary Outcome
Time from meeting protocol-specified infusion criteria to the start of convalescent plasma infusion, measured in days.
Conditions Studied
Interventions
- OTHER Standard of Care
- BIOLOGICAL Convalescent Plasma 1 Unit
- BIOLOGICAL Convalescent Plasma 2 Units
Study Locations (1)
West Virginia
- WVU Medicine - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2020-04-16 |
| Est. Completion | 2021-03-30 |
| Phase | Phase 3 |
What NCT04376034 shows while recruiting
NCT04376034 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with COVID-19 appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT04376034 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT04376034 about?
NCT04376034 is a clinical study titled "Convalescent Plasma Collection and Treatment in Pediatrics and Adults". This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19 in accordance to collection guidelines for plasma and FDA IND requirement. This study will include up to 240 participants potentially rec...
What is the current status of trial NCT04376034?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2020-04-16. Estimated completion is 2021-03-30.
What conditions does trial NCT04376034 study?
This clinical trial studies the following conditions: COVID-19, Corona Virus Infection, Coronavirus, Virus Diseases, RNA Virus Infections.
What interventions are being tested in trial NCT04376034?
The interventions under investigation include: Standard of Care (OTHER), Convalescent Plasma 1 Unit (BIOLOGICAL), Convalescent Plasma 2 Units (BIOLOGICAL).
Who is sponsoring clinical trial NCT04376034?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04376034 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04376034's enrollment target sits among peer trials
240 151st of 298 higher than 147 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 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.
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