Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
Public ClinicalTrials.gov record NCT04311697. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ZYESAMI (Aviptadil) for the Treatment of Critical COVID-19 With Respiratory Failure
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04311697
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 203 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 15, 2020 (Actual)
- Primary completion
- Feb 22, 2021 (Actual)
- Completion
- Feb 22, 2021 (Actual)
- Last update posted
- Jul 24, 2023
2020 – 2021
United States locations
- U.S. sites
- 10
- U.S. states
- 5
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Jude Medical Center | Fullerton | California | 92835 | — |
| University of California - Irvine | Irvine | California | 92697 | — |
| Miller School of Medicine / University of Miami Medical Center | Miami | Florida | 33136 | — |
| Baptist Hospital of Miami | Miami | Florida | 33176 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| Heartland/Mosaic Health | Saint Joseph | Missouri | 64506 | — |
| Hendrick Health | Abilene | Texas | 79601 | — |
| Texas Health Harris Methodist Hospital | Fort Worth | Texas | 76104 | — |
| Texas Health Hospital Frisco | Frisco | Texas | 75033 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04311697, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 24, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04311697 live on ClinicalTrials.gov.