Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure
Status:
Completed
Trial end date:
2021-02-22
Target enrollment:
Participant gender:
Summary
Novel Corona Virus (SARS-CoV-2) is known to cause Respiratory Failure, which is the hallmark
of Acute COVID-19, as defined by the new NIH/FDA classification. Approximately 50% of those
who develop Critical COVID-19 die, despite intensive care and mechanical ventilation.
Patients with Critical COVID-19 and respiratory failure, currently treated with high flow
nasal oxygen, non-invasive ventilation or mechanical ventilation will be treated with ZYESAMI
(aviptadil), a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) plus maximal
intensive care vs. placebo + maximal intensive care. Patients will be randomized to
intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
NeuroRx, Inc.
Collaborators:
Lavin Consulting, LLC Relief Therapeutics Holding SA