A clinical trial of Intravenous Aviptadil along with standard treatment in severe COVID-19 Patients with respiratory failure.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/04/033118
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
1.Severe COVID-19 with respiratory failure
2.Physician determination that patient is on maximal conventional medical therapy
3.Without Mechanical ventilation or with mechanical ventilation < 7 days
1.Age <18 years
2.Mechanical ventilation for more than 7 days.
3.Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol
4.Irreversible condition (other than COVID-19) with projected fatal course
5.Requirement of Extracorporeal membrane oxygenation (ECMO)
6.Current or recent (within 30 d) enrolment in another investigational trial of anti-IL6 drug;
7.Active diagnosis of Acquired immune deficiency syndrome;
8.Transplant patients currently immunosuppressed;
9.Chemotherapy-induced neutropenia (granulocyte count <1000/mm3);
10.Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4;
11.Recent myocardial infarction - within last 6 months and troponin > 0.5
12.Anuria (urine output < 50 ml/d) or other signs of multi-organ failure
13.Severe liver disease with portal hypertension;
14.Recent stroke or head trauma within last 12 months
15.Increased intracranial pressure, or other serious neurologic disorder;
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
17.Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method