Status:
NO_LONGER_AVAILABLE
ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE)
Lead Sponsor:
APR Applied Pharma Research s.a.
Conditions:
Critical COVID-19 With Respiratory Failure
Eligibility:
All Genders
12-100 years
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...
Detailed Description
5\. INTRODUCTION 5.1 Executive Summary ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP), a ubiquitous, naturally synthesized human peptide with extensively documente...
Eligibility Criteria
Inclusion
- Critical COVID-19 with Respiratory Failure
Exclusion
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04453839
Last Update
February 3 2023
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Dignity Health-Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
2
Honor Health Shea Medical Center
Scottsdale, Arizona, United States, 85260
3
Kaiser Permanente
Baldwin Park, California, United States, 91706
4
University of California - Irvine
Irvine, California, United States, 92697