Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

• Status: Completed
• Trial end date: 2021-02-22
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeuroRx, Inc.
• Collaborators: Lavin Consulting, LLC; Relief Therapeutics Holding SA
• Treatments: Phentolamine; Vasoactive Intestinal Peptide

Criteria

Inclusion Criteria:

• Critical COVID-19 with respiratory failure

• Physician determination that patient is on maximal conventional medical therapy

Exclusion Criteria:

1. Pregnancy (pregnant women may apply for open label treatment under compassionate care IND

2. Age <18 years

3. Mechanical ventilation for more than 7 days in primary cohort. Mechanical ventilation>21 days in the exploratory cohort

4. Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol

5. Irreversible condition (other than COVID-19) with projected fatal course

6. ECMO

7. Current or recent (within 30 d) enrollment in another investigational trial of anti-IL6 drug;

8. Active diagnosis of Acquired immune deficiency syndrome;

9. Transplant patients currently immunosuppressed;

10. Chemotherapy-induced neutropenia (granulocyte count <1000/mm3);

11. Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4;

12. Recent myocardial infarction - within last 6 months and troponin > 0.5

13. Anuria (urine output < 50 ml/d) or other signs of multi-organ failure

14. Severe liver disease with portal hypertension;

15. Recent stroke or head trauma within last 12 months

16. Increased intracranial pressure, or other serious neurologic disorder;

17. 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