Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Convalescent Plasma: 200 ml of ABO compatible plasma transfusion will be done to the subject randomized for the therapy
Control Intervention1: Standard care of treatment: control group
Sponsors
Max Super Speciality Hospital A Unit of Devki Devi Foundation
Eligibility
Inclusion 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 a. PaO2/ FiO2 b. Respiratory Rate > 24/min and SaO2 < 93% on room air
Exclusion criteria
Exclusion criteria: 1. Pregnant women 2. Breastfeeding women 3. Known hypersensitivity to blood products 4. Receipt of Pooled Immunoglobulin in last 30 days 6. Participating in any other clinical trial 7. Clinical status precluding infusion of blood products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a composite measure of the avoidance of - 1. Progression to severe ARDS (P/F ratio 100) and 2. All-cause Mortality at 28 daysTimepoint: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to symptom resolution-Fever,Shortness of Breath,Fatigue 2. Hospital length of stay 3. Change in SOFA pre and post transfusion 4. Duration of respiratory support required 5. Radiological improvement 6. Adverse events (AE) associated with transfusion 7. To measure the change in RNA levels (Ct values) of SARS-CoV-2 from RT-PCR [Time Frame: Days 0, 1, 3, and 7 after transfusion] 8. Levels of bio-markers pre and post transfusion 9. Need of Vasopressor use Timepoint: one year | — |
Countries
India
Contacts
Public ContactRajesh Saxena
Blood Bank, Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)
Outcome results
None listed