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NCT04319731 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure
A Early Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT04319731: Completed Early Phase 1 study, sponsored by University of Utah.
NCT04319731 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04319731, a Early Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and fibrosis in patients with a variety of medical conditions. The investigators hypothesize that using nebulized and/or intravenous purified (acellular) amniotic fluid will reduce both inflammation in patients hospitalized for in SARS CoV-2 (COVID19)-associated respiratory failure, potentially leading to a decrease in respiratory support.
Primary Outcome
Days alive and off mechanical ventilation at day 60. Measured only among patients who receive invasive mechanical ventilation.
Interventions
- BIOLOGICAL Human Amniotic Fluid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-03-20 |
| Est. Completion | 2020-06-09 |
| Phase | Early Phase 1 |
What the finished NCT04319731 record still lists
NCT04319731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Human Amniotic Fluid is the first listed.
NCT04319731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04319731 about?
NCT04319731 is a clinical study titled "A Pilot Study of Human Amniotic Fluid for COVID19 Associated Respiratory Failure". The purpose of this study is to test the effect of purified (acellular) amniotic fluid as a treatment for SARS CoV-2 (COVID19)-associated respiratory failure. Past use of human amniotic products (i.e., membrane and fluid) is FDA-approved for tissue injury and has been used to reduce inflammation and...
What is the current status of trial NCT04319731?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2020-03-20. Estimated completion is 2020-06-09.
What interventions are being tested in trial NCT04319731?
The interventions under investigation include: Human Amniotic Fluid (BIOLOGICAL).
Who is sponsoring clinical trial NCT04319731?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04319731's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 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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