drugset / Trial / NCT04346446

Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients

NCT04346446

Phase 2 Completed 29 enrolled Institute of Liver and Biliary Sciences, India
RandomizedParallel-groupOpen-labelTreatment

Summary

Currently, no effective treatments are available for the COVID-19 pandemic, which is related to more than 70,000 deaths all over the world. 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 COVID019 infected patients. We have planned a randomized controlled trial to assess the efficacy of this therapy in COVID-19 infected sick patients. We will collect up to 500 ml Convalescent Plasma from the COVID-19 infected recovered patient after 14 days of clinical and radiological recovery with two consecutive COVID-19 negative tests by PCR. We will further test the sample from the collected plasma for COVID-19 specific antibodies and their titer. This plasma will be frozen and sent to the treating center (MAMC). 200-600 ml of convalescent plasma will be transfused to patients who fit the eligibility criteria and are randomized to the convalescent plasma group. This will be done in severely sick patients. Data will be collected for the benefit and adverse events related to convalescent plasma transfusion.

Timeline

Start
2020-04-20
Primary completion
2020-05-30
Completion
2020-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Convalescent Plasma Protein / enzyme biologic 200 ml Other
Subject Convalescent Plasma Protein / enzyme biologic 600 ml Other
Comparator Random Donor Plasma Unknown 200 ml Other
Comparator Random Donor Plasma Unknown 600 ml Other

Indications