Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Convalescent plasma: Convalescent plasma, 2 doses of 200 mL each, from recovered COVID-19 patient.
Control Intervention1: Usual care for COVID-19 disease: Usual care for COVID-19 diseas
Sponsors
Indian Council Of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients admitted with RT-PCR confirmed COVID-19 illness. 2. Age > 18 years 3. Has any of the two a. PaO2/ FiO2: 200-300 b. Respiratory Rate > 24/min and SaO2 4. Availability of matched donor plasma at the point of enrolment
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 5. Critically ill patients: a. P/F ratio b. Shock 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) or 2. All-cause Mortality at 28 days Timepoint: 28 days from intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to symptom resolution a. Fever b. Shortness of Breath c. Fatigue Timepoint: 1,3,5,7,14 days;5. Duration of respiratory support required a. Duration of Invasive Mechanical Ventilation b. Duration of Non-Invasive Timepoint: 5. Duration of respiratory support required a. Duration of Invasive Mechanical Ventilation b. Duration of Non-Invasive ;Adverse events (AE) associated with transfusionTimepoint: Adverse events (AE) associated with transfusion;Change in oxygen requirement post transfusionTimepoint: 0,1,3,5,7,14;Change in SOFA pre and post transfusionTimepoint: 0,1,3,5,7,14;Correlation between IgG antibody in donor plasma and recipient plasma after transfusion.Timepoint: 0, 1,3,7;Correlation between viral neutralization titer and Elisa antibody assay in donor plasmaTimepoint: Correlation between viral neutralization titer and Elisa antibody assay in donor plasma;Length of hospital stayTimepoint: Length of hospital stay;Levels of bio-markers (CRP, IL6, Ferritin) pre and post transfusionTimepoint: 0, 3;Need of Vasopressor useTimepoint: Need of Vasopressor use;Pre and post transfusion antibody titers (IgG) in recipient plasma Timepoint: 0,3,7 days;Radiological improvementTimepoint: 0,3,7 days;To measure the change in RNA levels (Ct values) of SARS-CoV-2 from RT-PCR transfusion]Timepoint: Days 0, 3, and 7 | — |
Countries
India
Contacts
Public ContactDr Anup Agarwal
Indian Council of Medical Research
Outcome results
None listed