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NCT04311697 · ClinicalTrials.gov registry record · Phase 2
Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
A Phase 2 study, sponsored by APR Applied Pharma Research s.a..
- Completed
- Registry status
- Phase 2
- Development phase
- 203
- Enrollment target
NCT04311697: Completed Phase 2 study, sponsored by APR Applied Pharma Research s.a..
NCT04311697 is a Phase 2 study that has completed, run by APR Applied Pharma Research s.a.. The registered enrollment target is 203 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04311697, a Phase 2 study, has completed, sponsored by APR Applied Pharma Research s.a..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 203 participants
- Enrollment target
Study Summary
Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-19 and respiratory failure, currently treated with high flow nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with ZYESAMI (aviptadil), a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal intensive care vs. placebo + maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.
Primary Outcome
Participant is Alive and Free of Respiratory Failure (without subsequent relapse over 7 days) determined as no longer requiring acute care or more than low flow oxygen
Interventions
- DRUG Aviptadil by intravenous infusion + standard of care
- DRUG Normal Saline Infusion + standard of care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2020-05-15 |
| Est. Completion | 2021-02-22 |
| Phase | Phase 2 |
What the finished NCT04311697 record still lists
NCT04311697 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 2 interventions - of which Aviptadil by intravenous infusion + standard of care is the first listed.
NCT04311697 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04311697 about?
NCT04311697 is a clinical study titled "Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure". Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those who develop Critical COVID-19 die, despite intensive care and mechanical ventilation. Patients with Critical COVID-...
What is the current status of trial NCT04311697?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 203 participants. The study started on 2020-05-15. Estimated completion is 2021-02-22.
What interventions are being tested in trial NCT04311697?
The interventions under investigation include: Aviptadil by intravenous infusion + standard of care (DRUG), Normal Saline Infusion + standard of care (DRUG).
Who is sponsoring clinical trial NCT04311697?
This trial is sponsored by APR Applied Pharma Research s.a., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04311697's enrollment target sits among peer trials
203 301st of 2000 higher than 1,700 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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