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NCT04360096 · ClinicalTrials.gov registry record · Phase 2
Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19
A Phase 2 study, sponsored by APR Applied Pharma Research s.a..
- Terminated
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
NCT04360096: Clinical Trial Phase 2 study, sponsored by APR Applied Pharma Research s.a..
NCT04360096 is a Phase 2 study that was terminated before completion, run by APR Applied Pharma Research s.a.. The registered enrollment target is 144 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04360096, a Phase 2 study, was terminated before completion, sponsored by APR Applied Pharma Research s.a..
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
Study Summary
Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care. Patients with severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer. The primary outcome will be progression in severity of COVID-19 (i.e. critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.
Primary Outcome
Progression to Respiratory Failure is defined as the need for mechanical ventilation, non-invasive ventilation or high flow nasal oxygen
Interventions
- DRUG Placebo
- DRUG ZYESAMI™ (aviptadil acetate)
- DEVICE Nebulized administration of ZYESAMI™ or Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 2 |
Why NCT04360096 stopped before completion
NCT04360096 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04360096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04360096 about?
NCT04360096 is a clinical study titled "Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19". Brief Summary: SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported a...
What is the current status of trial NCT04360096?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2021-02-15. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT04360096?
The interventions under investigation include: Placebo (DRUG), ZYESAMI™ (aviptadil acetate) (DRUG), Nebulized administration of ZYESAMI™ or Placebo (DEVICE).
Who is sponsoring clinical trial NCT04360096?
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 NCT04360096's enrollment target sits among peer trials
144 500th of 2000 higher than 1,494 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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