COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57078

K Ravinder Reddy

aditi.datta@biositeindia.com

2021-06-24

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Male or female subjects having age 18 years to 60 years. <br/ >2. Subject and/or his/her legally accepted representative willing to give written informed consent. <br/ >3. Subjects having Critical COVID-19 with ARDS/respiratory failure requiring either mechanical ventilation, non-invasive <br/ >ventilation, or high flow rate nasal cannula at minimum 20L flow and 50% FIO2. <br/ >(Severe cases of COVID-19 as per MoH & FW guidelines on â??Clinical Management Protocol: COVID-19â?? as updated from <br/ >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: <br/ >ï?· SpO2 <90% on room air <br/ >ï?· Severe respiratory distress <br/ >ï?· Respiratory rate more than 30 per minute

1. Subject with history of hypersensitivity to Aviptadil or to any of the excipient. <br/ >2. Subjects on Mechanical ventilation for more than 7 days. <br/ >3. Transplant subjects currently immunosuppressed, <br/ >4. Subjects with Chemotherapy-induced neutropenia <br/ >(granulocyte count <1000/mm3), <br/ >5. Subjects with Cardiogenic shock, congestive heart failure â?? NYHA Class 3 or 4, <br/ >6. Subjects with Recent myocardial infarction â?? within last 6 months and troponin > 0.5. <br/ >7. Subjects with anuria (urine output < 50 ml/d) or other signs of multi-organ failure, <br/ >8. Irreversible condition (other than COVID-19) with projected fatal course. <br/ >9. Requirement of Extracorporeal membrane oxygenation (ECMO) <br/ >10. Severe liver disease with portal hypertension, <br/ >11. Recent stroke or head trauma within last 12 months <br/ >12. Increased intracranial pressure, or other serious neurologic disorder, <br/ >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. <br/ >14. Hypotension (i.e. Mean Arterial Pressure <65mmHg) that cannot be managed with pressors <br/ >15. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. <br/ >16. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. <br/ >17. Subjects with history of HIV and or Hepatitis B and or Hepatitis C. <br/ >18. Suspected inability or unwillingness to comply with the study procedures. <br/ >19. Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patientâ??s safety and efficacy of the drug. <br/ >20. Participation in any clinical study during last three months.

2

MSN Laboratories Private Limited

18

60

India

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

152

Recovery from Respiratory failure or ARDS by day 28 <br/ >(Recovery is defined as being able to maintain a physiologic <br/ >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 <br/ >(Recovery is defined as being able to maintain a physiologic <br/ >oxygen saturation (SaO2) without the need for mechanical ventilation; non-invasive ventilation; or high-flow Nasal Oxygen above 20L/min)

| Declared number of arm (5.0) differs from found arms (6.0)

Phase 3

[{"arm_notes": "", "treatment_id": 154, "treatment_name": "Aviptadil", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]