Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Aviptadil for Injection 500 mcg/vial and standard of care (SOC): Subjects will be treated with investigational product Aviptadil by IV
infusion over 12 hours in escalating doses from 5
Sponsors
MSN Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects having age 18 years to 60 years. 2. Subject and/or his/her legally accepted representative willing to give written informed consent. 3. Subjects having Critical COVID-19 with ARDS/respiratory failure requiring either mechanical ventilation, non-invasive ventilation, or high flow rate nasal cannula at minimum 20L flow and 50% FIO2. (Severe cases of COVID-19 as per MoH & FW guidelines on ââ?¬Å?Clinical Management Protocol: COVID-19ââ?¬? as updated from time to time. Case of severe COVID-19 defined as presence of clinical features of pneumonia (fever, cough, dyspnea and/ or hypoxia) with any of the following: ïâ??· SpO2 ïâ??· Severe respiratory distress ïâ??· Respiratory rate more than 30 per minute
Exclusion criteria
Exclusion criteria: 1. Subject with history of hypersensitivity to Aviptadil or to any of the excipient. 2. Subjects on Mechanical ventilation for more than 7 days. 3. Transplant subjects currently immunosuppressed; 4. Subjects with Chemotherapy-induced neutropenia (granulocyte count 5. Subjects with Cardiogenic shock; congestive heart failure ââ?¬â?? NYHA Class 3 or 4; 6. Subjects with Recent myocardial infarction ââ?¬â?? within last 6 months and troponin > 0.5. 7. Subjects with anuria (urine output 8. Irreversible condition (other than COVID-19) with projected fatal course. 9. Requirement of Extracorporeal membrane oxygenation (ECMO) 10. Severe liver disease with portal hypertension; 11. Recent stroke or head trauma within last 12 months 12. Increased intracranial pressure, or other serious neurologic disorder; 13. 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. 14. Hypotension (i.e. Mean Arterial Pressure 15. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. 16. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. 17. Subjects with history of HIV and or Hepatitis B and or Hepatitis C. 18. Suspected inability or unwillingness to comply with the study procedures. 19. Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patientââ?¬•s safety and efficacy of the drug. 20. Participation in any clinical study during last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery from Respiratory failure or ARDS by day 28 (Recovery is defined as being able to maintain a physiologic oxygen saturation (SaO2) without the need for mechanical ventilation, non-invasive ventilation, or high-flow Nasal Oxygen above 20L/min)Timepoint: Recovery from Respiratory failure or ARDS by day 28 (Recovery is defined as being able to maintain a physiologic oxygen saturation (SaO2) without the need for mechanical ventilation, non-invasive ventilation, or high-flow Nasal Oxygen above 20L/min) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in inflammatory marker cytokines IL-6 and TNF Alpha levels from baseline toTimepoint: Days 3 (following the end of infusion),7, 14, 28 or discharge, whichever is earlier;Improvement in PaO2:FiO2 ratioTimepoint: Day 0 through Day 28;Proportion of patients with 2-point decrease in ordinal scale (as recommended by WHO)Timepoint: Day 0 to Day 28;Survival Rate in severe COVID-19 patients with respiratory failureTimepoint: 7 days with follow up through 28 days maximum;Time to discharge aliveTimepoint: Day 0 to Day 28;Time to ICU dischargeTimepoint: Day 0 to Day 28 | — |
Countries
India
Contacts
Public ContactK Ravinder Reddy
Biosite Research Private Limited
Outcome results
None listed