Convalescent Plasma was not associated with reduction in mortality or progression to severe Covid-19, suggests a study by Indian Council of Medical Research published in MedRxiv, a preprint server for health sciences. ICMR officials told The Indian Express that the study, published on September 8, has not been peer-reviewed and preferred not to comment.
While use of convalescent plasma as a treatment modality for Covid-19 has received authorisation for off-label use in India, the aim of ICMR’s PLACID trial was to investigate its effectiveness for treatment of Covid-19.
The PLACID trial results indicate that there was no difference in the 28-day mortality or progression to severe disease among moderately-ill Covid-19 patients treated with convalescent plasma along with basic standard care compared to basic standard care alone.
Convalescent plasma therapy uses blood from people who have recovered from an illness to help others recover. Blood donated by people who have recovered from Covid-19 has antibodies to the virus that causes it. The donated blood is processed to remove blood cells, leaving behind liquid (plasma) and antibodies. These can be given to people with Covid-19 to boost their ability to fight the virus.
ICMR’s plasma therapy study, PLACID, is the first and largest randomised control trial to be completed in the world and according to the study paper, two earlier studies from China and the Netherlands could not be completed.
The randomised controlled was registered with Clinical Trial Registry of India (CTRI) and conducted in 39 tertiary care hospitals across the country. Between April 22 and July 14, a total of 464 participants were enrolled—235 and 229 in the intervention and control arms, respectively.
Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in the intervention and control arm, respectively.
Convalescent plasma therapy has received regulatory approval for use in patients in different countries, leading to its wide adoption.