A clinical trial of Intravenous Aviptadil along with standard treatment in Subjects Hospitalized with Respiratory failure/acute respiratory distress syndrome associatedwith severe Coronavirus Disease (COVID-19).
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/06/034373
- Lead Sponsor
- MSN Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 74
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 <90% on room air
ïâ??· Severe respiratory distress
ïâ??· Respiratory rate more than 30 per minute
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 <1000/mm3);
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 < 50 ml/d) or other signs of multi-organ failure;
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 <65mmHg) that cannot be managed with pressors
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recovery from Respiratory failure or ARDS by day 28 <br/ ><br>(Recovery is defined as being able to maintain a physiologic <br/ ><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/ ><br>(Recovery is defined as being able to maintain a physiologic <br/ ><br>oxygen saturation (SaO2) without the need for mechanical ventilation, non-invasive ventilation, or high-flow Nasal Oxygen above 20L/min)
- Secondary Outcome Measures
Name Time Method Change in inflammatory marker cytokines IL-6 and TNF Alpha <br/ ><br>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 <br/ ><br>scale (as recommended by WHO)Timepoint: Day 0 to Day 28;Survival Rate in severe COVID-19 patients with respiratory <br/ ><br>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