ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE)
SAMICARE
1 other identifier
expanded_access
N/A
1 country
25
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 1, 2020
CompletedFebruary 3, 2023
January 1, 2022
June 27, 2020
February 2, 2023
Conditions
Interventions
Patients will be treated with 12 hour infusions of ZYESAMI at ascending doses of 50/100/150 pmol/kg/hr on 3 or more successive days
Eligibility Criteria
You may qualify if:
- Critical COVID-19 with Respiratory Failure
You may not qualify if:
- Patients who are eligible for enrollment in RLF-100\_001 are excluded from this protocol and live within 50 miles of a study site for NCT04311697 cannot be enrolled unless already admitted to an ICU and ineligible for transfer
- Mean Arterial Pressure \< 65 mm Hg with use of pressor per ICU protocol
- Irreversible condition (other than COVID-19) with projected fatal course
- ECMO
- Chemotherapy-induced neutropenia (granulocyte count \<1000/mm3);
- Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4;
- Liquid Diarrhea more than 3x/day; defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Dignity Health-Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Honor Health Shea Medical Center
Scottsdale, Arizona, 85260, United States
Kaiser Permanente
Baldwin Park, California, 91706, United States
University of California - Irvine
Irvine, California, 92697, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950, United States
Lakeland Regional Health
Lakeland, Florida, 33805, United States
Miller School of Medicine / University of Miami Medical Center
Miami, Florida, 33136, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Baycare St. Joseph Hospital
Tampa, Florida, 33607, United States
Southeast Georgia Health system
Brunswick, Georgia, 31520, United States
Maui Health Systems
Wailuku, Hawaii, 96793, United States
St. Anthony Regional Hospital
Carroll, Iowa, 51401, United States
University of Louisville
Louisville, Kentucky, 40202, United States
St. Tammany Parish Hospital
Covington, Louisiana, 70433, United States
Our Ladies of Lourdes Regional Hospital
Lafayette, Louisiana, 70508, United States
St. Joseph Heritage Healthcare
Saint Joseph, Missouri, 64506, United States
Great Plains Health
North Platte, Nebraska, 69101, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Hendrick Medical Center
Abilene, Texas, 79601, United States
Baptist Hospitals of Southeast Texas
Beaumont, Texas, 77701-4689, United States
Medical City Denton
Denton, Texas, 76210, United States
HR Health Institute for Research & Development
Edinburg, Texas, 78539, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Memorial Hermann Hospital Houston
Houston, Texas, 77030, United States
Medical City McKinney
McKinney, Texas, 75609, United States
Related Links
- Intravenous Aviptadil Is Associated with Increased Recovery and Survival in Patients with COVID-19 Respiratory Failure: Results of a 60-Day Randomized Controlled Trial
- Brief Report: Rapid Clinical Recovery From Critical Coronavirus Disease 2019 With Respiratory Failure in a Pregnant Patient Treated With IV Vasoactive Intestinal Peptide
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jonathan C Javitt, MD, MPH
NRx Pharmaceuticals, Inc.
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2020
First Posted
July 1, 2020
Last Updated
February 3, 2023
Record last verified: 2022-01