NEW DELHI: The India Council of Medical Research (ICMR) in a study has found that Convalescent Plasma (CP) therapy is ineffective in reducing deaths from the novel coronavirus. To investigate the effectiveness of plasma therapy for COVID-19 treatment, ICMR conducted a study in 39 hospitals across India and revealed the CP therapy’s ineffectiveness. An open-label, parallel-arm, phase II, multicentre, and randomized controlled trial from April 22 to July 14 was conducted by the ICMR researchers and registered with the Clinical Trial Registry of India (CTRI).
In total, 1,210 patients (moderately ill confirmed COVID-19) were screened in 39 trial sites. Of these 39 trials sites, 29 used to be teaching public hospitals and 10 were private hospitals spread across 14 states and Union Territories representing 25 cities.
The study was conducted on randomly enrolled 464 participants who were hospitalized and moderately-ill confirmed COVID-19 patients. Out of these, around 235 participants were in the intervention arm and 229 subjects in the control arm. The study indicated that participants were randomized to either control or intervention arm. In the intervention arm, two doses of 200 ml CP was injected with a 24-hour gap. Composite primary result was noted in 44 (18.7 per cent) participants in the intervention arm and 41 (17.9 per cent) in the control arm. In 34 (13.6 per cent) participants under intervention arm and 31 (14.6 per cent) under control arm, mortality was recorded.
According to the findings of the study, CP was not linked to decrease in mortality or leading to severity in COVID-19. The trial is highly generalized and resembles the real-life setting of convalescent plasma therapy in laboratory conditions. The role of CP in the management of COVID-19 can be further clarified by a priori measurement of the amount of neutralizing antibody in donors and participants.