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

NCT04453839 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2023-02-03

No results posted yet for this study

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

Conditions

  • Critical COVID-19 With Respiratory Failure

Interventions

DRUG

ZYESAMI (aviptadil acetate)

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

Sponsors & Collaborators

  • APR Applied Pharma Research s.a.

    lead OTHER

Principal Investigators

  • Jonathan C Javitt, MD, MPH · NRx Pharmaceuticals, Inc.

Eligibility

Min Age
12 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04453839 on ClinicalTrials.gov