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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04360096
The ClinicalTrials.gov registry entry for NCT04360096 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is APR Applied Pharma Research s.a., which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04360096 reports 0 study locations.
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.
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