Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19
Public ClinicalTrials.gov record NCT04360096. 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
Inhaled ZYESAMI™ for the Treatment of Severe COVID-19
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04360096
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 144 participants
Conditions and interventions
Conditions
Interventions
- ZYESAMI™ (aviptadil acetate) Drug
- Placebo Drug
- Nebulized administration of ZYESAMI™ or Placebo Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years to 85 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
- Feb 14, 2021
- Primary completion
- Dec 14, 2021
- Completion
- Dec 30, 2021
- Last update posted
- Feb 2, 2023
2021
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Jude Medical Center | Fullerton | California | 92835 | — |
| University of California - Irvine | Irvine | California | 92697 | — |
| University of Miami Leonard M. Miller School of Medicine (UMMSM) | Miami | Florida | 33136 | — |
| Advent Health Research Institute | Orlando | Florida | 32803 | — |
| Northwestern Medical Group | Winfield | Illinois | 60190 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| Great Plains Health | North Platte | Nebraska | 69101 | — |
| University Medical Center | Las Vegas | Nevada | 89102 | — |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | — |
| Kettering Health Network | Kettering | Ohio | 45429 | — |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | — |
| Self Regional Healthcare | Greenwood | South Carolina | 29646 | — |
| University of Texas San Antonio Medical Arts and Research Center | San Antonio | Texas | 78229 | — |
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 NCT04360096, 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 Feb 2, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04360096 live on ClinicalTrials.gov.