ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE)
Public ClinicalTrials.gov record NCT04453839. 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) Intermediate Population Expanded Access Protocol
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Patients with Critical COVID-19 and respiratory failure who are ineligible for enrollment in NCT04311697, who live more than 50 miles from an existing collaborating research center, or who are already hospitalized and cannot safely be transferred to a collaborating research facility may be considered for expanded access by the sponsor. Treating physicians must complete FDA Form 3396 and receive a letter of authorization from NeuroRx, along with local IRB authorization. Please refer to FDA guidance for Individual Patient Expanded Access https://www.fda.gov/media/91160/download
Study identification
- NCT ID
- NCT04453839
- Recruitment status
- No Longer Available
- Study type
- Expanded access
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Feb 3, 2023
United States locations
- U.S. sites
- 25
- U.S. states
- 12
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dignity Health-Mercy Gilbert Medical Center | Gilbert | Arizona | 85297 | — |
| Honor Health Shea Medical Center | Scottsdale | Arizona | 85260 | — |
| Kaiser Permanente | Baldwin Park | California | 91706 | — |
| University of California - Irvine | Irvine | California | 92697 | — |
| Lawnwood Regional Medical Center | Ft. Pierce | Florida | 34950 | — |
| Lakeland Regional Health | Lakeland | Florida | 33805 | — |
| Miller School of Medicine / University of Miami Medical Center | Miami | Florida | 33136 | — |
| Baptist Hospital of Miami | Miami | Florida | 33176 | — |
| Baycare St. Joseph Hospital | Tampa | Florida | 33607 | — |
| Southeast Georgia Health system | Brunswick | Georgia | 31520 | — |
| Maui Health Systems | Wailuku | Hawaii | 96793 | — |
| St. Anthony Regional Hospital | Carroll | Iowa | 51401 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| St. Tammany Parish Hospital | Covington | Louisiana | 70433 | — |
| Our Ladies of Lourdes Regional Hospital | Lafayette | Louisiana | 70508 | — |
| St. Joseph Heritage Healthcare | Saint Joseph | Missouri | 64506 | — |
| Great Plains Health | North Platte | Nebraska | 69101 | — |
| Self Regional Healthcare | Greenwood | South Carolina | 29646 | — |
| Hendrick Medical Center | Abilene | Texas | 79601 | — |
| Baptist Hospitals of Southeast Texas | Beaumont | Texas | 77701-4689 | — |
| Medical City Denton | Denton | Texas | 76210 | — |
| HR Health Institute for Research & Development | Edinburg | Texas | 78539 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Memorial Hermann Hospital Houston | Houston | Texas | 77030 | — |
| Medical City McKinney | McKinney | Texas | 75609 | — |
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 NCT04453839, 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 3, 2023 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04453839 live on ClinicalTrials.gov.