Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Aviptadil 150mcg with
Standard of Care: Patients will be treated with 12-hour infusions of Aviptadil at ascending doses on 3 successive days. Patients will receive 0.166 mcg/kg/hr on Da
Sponsors
Zuventus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Severe COVID-19 with respiratory failure 2. Physician determination that patient is on maximal conventional medical therapy 3. Without Mechanical ventilation or with mechanical ventilation < 7 days
Exclusion criteria
Exclusion criteria: 1. Age 2. Mechanical ventilation for more than 7 days. 3. Mean Arterial Pressure 4. Irreversible condition (other than COVID-19) with projected fatal course 5. Requirement of Extracorporeal membrane oxygenation (ECMO) 6. Current or recent (within 30 d) enrolment in another investigational trial of anti-IL6 drug; 7. Active diagnosis of Acquired immune deficiency syndrome; 8. Transplant patients currently immunosuppressed; 9. Chemotherapy-induced neutropenia (granulocyte count 10. Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4; 11. Recent myocardial infarction - within last 6 months and troponin > 0.5 12. Anuria (urine output 13. Severe liver disease with portal hypertension; 14. Recent stroke or head trauma within last 12 months 15. Increased intracranial pressure, or other serious neurologic disorder; 16. Liquid diarrhea more than 3/day; defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation 17. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of Respiratory FailureTimepoint: Day 0 through Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in chest x-rayTimepoint: Day 0, Day 7 and Day 28;Improvement in inflammatory markersTimepoint: Day 0 through Day 28;Improvement on WHO ordinal scaleTimepoint: Day 0 through Day 28;Multi-organ failure free daysTimepoint: Day 0 through Day 28;Number of patients reporting incidences of adverse eventsTimepoint: Day 0 through Day 14;Respiratory Distress (PaO2:FiO2 ratio) while on mechanical ventilationTimepoint: Day 0 through Day 28;SurvivalTimepoint: Day 0 through Day 28 and Day 60;Time on ventilationTimepoint: Day 0 through Day 28;Time to discharge aliveTimepoint: Day 0 through Day 28;Time to extubationTimepoint: Day 0 through Day 28;Time to ICU dischargeTimepoint: Day 0 through Day 28 | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Limited
Outcome results
None listed