According to the results of the PLACID (PLAsma Convalescent InDia) trial, convalescent plasma in COVID-19 patients doesn’t forestall progression to severe disease or mortality. This study results from the Indian Council of Medical Research (ICMR) study in India. It is the first randomized controlled trial for plasma in COVID-19 patients completed worldwide. This study, conducted at 39 centers across India, involved 464 hospitalized and moderately ill COVID-19 patients. These patients received supplemental oxygen but were not critically ill with organ damage from April 22 to July 14.
With the results posted on the preprint server, unfortunately the results don’t align with the U.S. Food and Drug Administration, which recently and controversially issued an emergency use authorization.
Hugely Popular in India, it Leads to Black Market
Clinical investigator and study coauthor Pankaj Malhotra, clinical hematologist at the Postgraduate Institute of Medical Education and Research (PGIMER) in Chandigarh, reported that the use of convalescent plasma is incredibly popular in India now as the pandemic worsens in that country; total cases now are at 5,212,686. In fact, The Scientist’s Alakananda Dasgupta reports the Indian Health Ministry recommended the off-label use of convalescent plasma in COVID-19 patients who evidence no improvement despite the standard of care.
In fact, Malhotra hopes that these clinical trial results may actually slow down or even stop a huge illegal trade in convalescent plasma in India.
Experts Chime In
The Scientist quoted Arturo Casadevall, an immunologist, saying, “It’s the first RCT that was completed for convalescent plasma and I think that is a significant accomplishment.” The Scientist reports that an RCT was halted prematurely in China due to insufficient numbers of cases while one in the Netherlands was discontinued as antibody titers in recipients were actually comparable to those of donors, which raised questions about the benefits of this investigational product.
U.S. Clinical Trials
The Scientist reports that there are over 20 clinical trials involving convalescent plasma across the United States, however none have completed. TrialSite reported extensively on the Mayo Clinic-led national U.S. Expanded Access Program for COVID-19 convalescent plasma that actually led to the FDA’s EUA; however, this data didn’t derive from a randomized controlled trial.
Furthermore, the ICMR study reveals that convalescent plasma does improve symptoms and oxygenation as well as leads to expedited viral clearance in patients according to the trial results. Michael Joyner led the Mayo Clinic study (the one that led to the EUA by the FDA) and complimented the Indian investigators, “the authors, the Indian research council and the country deserve a lot of credit for doing this trial under very difficult circumstances,” according to Alakananda Dasgupta. Dr. Joyner noted, “I think that’s most impressive. So, high compliments there.”
Call to Action: Follow the link to The Scientist to read the entire article.