ICMR share the Global acceptance of the study on Effectiveness of Plasmatherapy in COVID-19.
Convalescent plasma was not associated with a reduction in progression to severe COVID-19 or all cause mortality.
British Medical Journal (BMJ) highly appreciates the Research on Plasmatherapy, continuous using in different places in India on COVID-19
Objectives of the Trial was-
To investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India.
Open label, parallel arm, phase II, multicentre, randomised controlled trial.
39 public and private hospitals across India.
464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19.
235 were assigned to convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm).
Interventions Participants in the intervention arm received two doses of 200 mL convalescent plasma, transfused 24 hours apart. The presence and levels of neutralising antibodies were not measured a priori; stored samples were assayed at the end of the study.
Main outcome measure Composite of progression to severe disease (PaO2/FiO2 <100 mm Hg) or all cause mortality at 28 days post-enrolment.
Progression to severe disease or all cause mortality at 28 days after enrolment occurred in 44 (19%) participants in the intervention arm and 41 (18%) in the control arm (risk difference 0.008 (95% confidence interval −0.062 to 0.078); risk ratio 1.04, 95% confidence interval 0.71 to 1.54).
Convalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality.
“This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.”- Study reveals.
Also added-“this did not translate into a reduction in 28 day mortality or progression to severe disease. Areas of future research could include effectiveness of convalescent plasma among neutralising antibody negative patients and the use of convalescent plasma with high neutralising antibody titres.
The challenge will be to find both suitable patients and suitable plasma donors. Additionally, this challenge could limit the use of convalescent plasma to a small subset of patients.”
Trial registration Clinical Trial Registry of India CTRI/2020/04/024775.