CTRI/2021/06/034373OtherPhase 3
A Randomized, Double blind, Placebo controlled Multi-centric, PhaseIII Clinical Trial to Evaluate the Efficacy and Safety of Aviptadil forInjection 500 mcg/vial in Treatment of Subjects Hospitalized withRespiratory failure/acute respiratory distress syndrome associatedwith severe Coronavirus Disease (COVID-19)
Trial Snapshot
- Phase
- Phase 3
- Status
- Other
- Enrollment
- 74
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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:
- •Ã¯â??· SpO2 <90% on room air
- •Ã¯â??· Severe respiratory distress
- •Ã¯â??· Respiratory rate more than 30 per minute
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 <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.
Investigators
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