drugset / Trial / NCT04425915

Efficacy of Convalescent Plasma Therapy in Patients With COVID-19

NCT04425915

Phase 3 Completed 400 enrolled Institute of Liver and Biliary Sciences, India
RandomizedParallel-groupOpen-labelTreatment

Summary

Currently, no effective treatments are available for the COVID-19. Scientists and Researchers are working on many aspects of treatment options for the development of vaccination and medication to combat this life-threatening problem. Convalescent plasma from recovered COVID-19 patients contains antibodies against COVID-19 which may be beneficial to severely sick COVID-19 patients. Investigator have recently concluded a pilot phase II open-label RCT on the efficacy of convalescent plasma in severe COVID 19 patients in which encouraging results were seen. Investigator plan to further study the efficacy and safety of convalescent plasma in COVID-19 severely sick patients through an RCT. Investigator will collect up to 500 ml Convalescent Plasma from the COVID-19 recovered persons after 14 days of clinical recovery with two consecutive SARS CoV-2 negative tests by PCR at least 24 hours apart. This plasma will be tested and frozen and stored. On requisition it will be thawed and sent to the treating center. Two doses of 250 ml convalescent plasma each will be transfused on two consecutive days to patients who fit the eligibility criteria (Severely sick COVID-19 patients) and are randomized to the convalescent plasma group along with the standard of care and the other group will receive standard of care alone. Data will be collected to study the benefits and adverse events related to convalescent plasma transfusion.

Timeline

Start
2020-06-14
Primary completion
2020-12-15
Completion
2020-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Convalescent Plasma Protein / enzyme biologic 250 ml Other

Indications