Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications
Status:
Active, not recruiting
Trial end date:
2021-08-09
Target enrollment:
Participant gender:
Summary
The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has
been declared to be a pandemic by the World Health Organization (WHO), Caused by the severe
acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 1,781,127
cases and 108,994 deaths globally (till 12th April, 2020), affecting 199 countries and 2
international conveyances. US FDA has recently approved Convalescent Plasma from patients
recovered from COVID 19 for the treatment of severe or life threatening COVID-19 infections.
In a small case series, five critically ill COVID-19 patients with ARDS were treated with
convalescent plasma containing neutralizing antibodies. Infusion of plasma was followed by
improvement in clinical status in all five patients, with no deaths and the study reported
that three patients were discharged, whilst two continued to be stable on mechanical
ventilation. We designed this phase II, open label, randomized clinical trial with the
primary objective to assess the safety and efficacy of the therapy in the second stage.