Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Infectious Diseases
Enrollment Eligibility
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