CONVALESCENT PLASMA THERAPY FOR COVID-19 PATIENTS: REGULATORY GUIDANCE ON COLLECTION, TESTING, PROCESSING, STORAGE, DISTRIBUTION, AND CLINICAL TRIALS
Convalescent Plasma Therapy for COVID-19
Convalescent plasma can be transfused to patients suffering from same infection or to prepare immunoglobulin concentrates. Plasma from recovered patients can be a valuable alternative during the COVID-19 pandemic for supporting its treatment within randomized clinical trial framework or case-control or observational studies of plasma transfusion and for preparing plasma-derived biological products. WHO Blood Regulators Network highlighted that a systematic approach for collection of convalescent plasma from patients recovered from COVID-19 can provide a useful intervention. Its safety and effectiveness are being assessed by structured clinical trials. The convalescent plasma therapy is still in experimental stage and is currently not included in interim clinical guidelines of WHO. However, an emergency investigational new drug application (eIND) process has been inducted so as to ensure availability of COVID-19 convalescent plasma to the patients with severe or life-threatening COVID-19 conditions. USFDA is regularly amending its guidance as new results and best practices are emerging. The write up provides an overview of convalescent plasma, from regulatory considerations viewpoint, systematic work flow protocol and a cross section of clinical trials underway.
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