Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications
COVID 19
About this trial
This is an interventional treatment trial for COVID 19
Eligibility Criteria
Inclusion Criteria:
1. Patients admitted with RT-PCR confirmed COVID-19 illness. 2. Age > 18 years 3. Written informed consent 4. Has any of the two
- PaO2/ FiO2 <300
- Respiratory Rate > 24/min and SaO2 < 93% on room air
Or In case of Severe or immediately life-threatening COVID-19, for example:
a. Severe disease is defined as: i. dyspnea, ii. respiratory frequency ≥ 30/min, iii. blood oxygen saturation ≤ 93%, iv. partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v. lung infiltrates > 50% within 24 to 48 hours b. Life-threatening disease is defined as: i. respiratory failure, ii. septic shock, and/or iii. multiple organ dysfunction or failure
Exclusion Criteria:
- 1. Pregnant women 2. Breastfeeding women 3. Known hypersensitivity to blood products 4. Receipt of Pooled Immunoglobulin in last 30 days 5. Participating in any other clinical trial 6. Clinical status precluding infusion of blood products
Sites / Locations
- Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Test Arm
Control Arm
50 subjects will be randomized in this arm. Patients in the test group will receive convalescent plasma.
50 subjects will be randomized in this arm and will be treated according to the standard care. The Ministry of Health and Welfare has issued detailed guidelines for the management of sCOVID-19 based on varying grades of severity. For the management of ARDS or sepsis, the respective guidelines issued by ARDSNet and Surviving Sepsis campaign will be followed. Other institutional protocols for supportive management will be implemented.