ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE)

NO_LONGER_AVAILABLE

Conditions studied: Critical COVID-19 With Respiratory Failure

In brief

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

Key facts

Study ID

NCT04453839

Run by

APR Applied Pharma Research s.a.

Last updated by the study team

2023-02-03

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Dignity Health-Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• Honor Health Shea Medical Center — Scottsdale, Arizona, United States
• Kaiser Permanente — Baldwin Park, California, United States
• University of California - Irvine — Irvine, California, United States
• Lawnwood Regional Medical Center — Ft. Pierce, Florida, United States
• Lakeland Regional Health — Lakeland, Florida, United States
• Miller School of Medicine / University of Miami Medical Center — Miami, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Baycare St. Joseph Hospital — Tampa, Florida, United States
• Southeast Georgia Health system — Brunswick, Georgia, United States
• Maui Health Systems — Wailuku, Hawaii, United States
• St. Anthony Regional Hospital — Carroll, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• St. Tammany Parish Hospital — Covington, Louisiana, United States
• Our Ladies of Lourdes Regional Hospital — Lafayette, Louisiana, United States
• St. Joseph Heritage Healthcare — Saint Joseph, Missouri, United States
• Great Plains Health — North Platte, Nebraska, United States
• Self Regional Healthcare — Greenwood, South Carolina, United States
• Hendrick Medical Center — Abilene, Texas, United States
• Baptist Hospitals of Southeast Texas — Beaumont, Texas, United States
• Medical City Denton — Denton, Texas, United States
• HR Health Institute for Research & Development — Edinburg, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Memorial Hermann Hospital Houston — Houston, Texas, United States
• Medical City McKinney — McKinney, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.