A multi-centric study funded by the Indian Council of Medical Research (ICMR) found that the use of convalescent plasma therapy in coronavirus-infected patients does not help in reducing mortality or progression to severe COVID-19.
The convalescent plasma therapy involves taking antibodies from the blood of a COVID-19 recovered person and transfusing into an active coronavirus patient in order to help kick-start the immune system.
The 'open-label parallel-arm phase II multicentre randomized controlled trial' (PLACID trial) was conducted between April 22 and July 14 across 39 Indian public and private hospitals. The trial was registered with the Clinical Trial Registry of India (CTRI) for the purpose and was conducted to find the effectiveness of convalescent plasma (CP) for the treatment of COVID-19.
Study methodology
A total of 1,210 patients (moderately ill confirmed COVID-19) admitted across 39 trial sites were screened. Of these, 29 were public hospitals and 10 were private hospitals spread across 14 states and Union Territories representing 25 cities.
The study was conducted on 464 participants who were hospitalized and moderately ill confirmed COVID-19 patients, and these 464 patients were randomly enrolled.
Out of which, about 235 participants were put in the intervention arm, while 229 subjects were in the control arm.
According to the study, participants were randomised to either control or intervention arm. Two doses of 200 ml CP was transfused 24 hours apart in the intervention arm.
"Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively," study mentioned.
Findings of the study
"The PLACID trial results indicate that there was no difference in 28-day mortality or progression to severe disease among moderately ill COVID-19 patients treated with CP along with BSC compared to BSC alone," the study said.
"The CP was not associated with a reduction in mortality or progression to severe COVID-19," the study said, adding this trial has high generalisability and approximates real-life setting of CP therapy in settings with limited laboratory capacity.
A prior measurement of neutralising antibody titres in donors and participants may further clarify the role of CP in the management of COVID-19, it said.
CP as a passive source of neutralising antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases.
Although CP is a safe therapeutic modality, plasmapheresis, plasma storage and NAb measurement are all resource-intensive processes, with a limited number of institutes in the country having the capacity to undertake these activities in a quality-assured manner.
CP therapy has received regulatory approval for use in patients in different countries. This has resulted in its widespread adoption in real-world clinical practice, where it is being used to treat COVID-19 patients with a wide spectrum of disease severity.
(With agency inputs)
