Study to assess the efficacy and safety of convalescent plasma in moderate COVID-19 disease

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: 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 disease CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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 OUTCOME: 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 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 < 93% on room air 4. Availability of matched donor plasma at the point of enrolment
Epistemonikos ID: a8b3160b40c47097b678a188d4e31ccedcaa4bef
First added on: Jun 24, 2020