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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 is a Phase 2 study that has completed, run by APR Applied Pharma Research s.a.. The registered enrollment target is 203 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04311697
The ClinicalTrials.gov registry entry for NCT04311697 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 203 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 2 interventions - of which Aviptadil by intravenous infusion + standard of care is the first listed.
NCT04311697 reports 0 study locations.
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.
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