A clinical trial for validating therapeutic efficacy of convalescent plasma in severe COVID-19 disease
Phase 2
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025209
- Lead Sponsor
- Council of Scientific and Industrial Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
Patients admitted with RNA PCR proven COVID-19 with
severe disease (fever or suspected respiratory infection, plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 < 90% at room air)
with Mild ARDS (200 mmHg < PaO2/FiO2 <= 300 mmHg, with PEEP or CPAP >=5 cm H2O, or non-ventilated)
or Moderate ARDS (100 mmHg < PaO2/FiO2 <=200 mmHg, with PEEP >=5 cm H2O, or non-ventilated)
within 5 to 10 days from initial presentation.
Exclusion Criteria
1. Pregnant mothers
2. Patients with age less than 18 years
3. Admitted late after 10 days of initial presentation
4. Patients refusing consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2. To compare â??all causeâ?? mortality <br/ ><br>3. To identify the immune correlates for response to plasma therapy. <br/ ><br>Timepoint: 1. Discharge <br/ ><br>2. Discharge/death <br/ ><br>3. Day 0, Day 3, Day 7 after admission
- Secondary Outcome Measures
Name Time Method 1. To compare recovery from ARDS in both groups <br/ ><br>2. To compare time taken to negative viral RNA PCR <br/ ><br>3. Adverse reaction to plasma therapyTimepoint: At discharge/death