COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53211

Dr Bhupesh Dewan

Bhupesh.Dewan@zuventus.com

2021-04-26

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Severe COVID-19 with respiratory failure <br/ >2. Physician determination that patient is on maximal conventional medical therapy <br/ >3. Without Mechanical ventilation or with mechanical ventilation < 7 days

1. Age <18 years <br/ >2. Mechanical ventilation for more than 7 days. <br/ >3. Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol <br/ >4. Irreversible condition (other than COVID-19) with projected fatal course <br/ >5. Requirement of Extracorporeal membrane oxygenation (ECMO) <br/ >6. Current or recent (within 30 d) enrolment in another investigational trial of anti-IL6 drug, <br/ >7. Active diagnosis of Acquired immune deficiency syndrome, <br/ >8. Transplant patients currently immunosuppressed, <br/ >9. Chemotherapy-induced neutropenia (granulocyte count <1000/mm3), <br/ >10. Cardiogenic shock, congestive heart failure - NYHA Class 3 or 4, <br/ >11. Recent myocardial infarction - within last 6 months and troponin > 0.5 <br/ >12. Anuria (urine output < 50 ml/d) or other signs of multi-organ failure <br/ >13. Severe liver disease with portal hypertension, <br/ >14. Recent stroke or head trauma within last 12 months <br/ >15. Increased intracranial pressure, or other serious neurologic disorder, <br/ >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 <br/ >17. Pregnant or lactating women

2

Zuventus Healthcare Limited

18

90

India

Critical disease at enrollment

8: Critical disease at enrollment

150

Resolution of Respiratory FailureTimepoint: Day 0 through Day 28

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "", "treatment_id": 155, "treatment_name": "Aviptadil (vasoactive intestinal peptide)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]