A healthcare worker collects swab samples from a woman at a testing site for COVID-19 in Mumbai, … [+]
While the U.S. Food and Drug Administration authorized emergency use of convalescent plasma therapy to treat Covid-19 patients, new findings from a randomized control trial conducted by India’s government found that plasma therapy does not reduce death rates and doesn’t stop the progression of the disease. The findings, which have not yet been peer-reviewed, were published online this week in the pre-print server Medrxiv.
“We were hoping for more promising results with this therapy. Had it shown beneficial effects, it would have been a great addition to the treatment protocols,” said Dr. Varsha Godbole, professor and head of department of medicine at GMERS medical college in Vadodara, Gujarat, India’s western state, which was one of the centers in the trial. India now has a total of 4.46 million cases, second highest in the world following the U.S and has recorded 75,062 Covid-19 deaths.
Plasma therapy involves removing blood plasma from patients who have recovered from Covid-19 and injecting it into patients with severe cases of the virus with the rationale that the transfusion can kick start an immune response in the recipients to fight off the infection and prevent its progression.
A total of 464 “moderately ill” Covid-19 patients were enrolled in the trial across 39 hospitals in India. Among them, 235 patients received plasma therapy, two doses of 200 milliliters plasma transfused 24 hours apart, in addition to the standard of care. The control group of 229 patients received just the standard of care.
At the end of the trial, 34 patients in the convalescent plasma therapy group had died as compared to 31 deaths in the control arm, which was not a statistically significant difference. Meanwhile, 17 patients from both the groups progressed to severe disease, showing that the therapy did not help in curtailing the infection. There were no major adverse effects reported.
“Convalescent plasma was not associated with reduction in mortality or progression to severe Covid-19,” the study, conducted by the Indian Council of Medical Research, concluded.
Even before the results of the trial, the therapy had gained immense popularity in India. Following the publication of the results of the trial, some doctors said they will continue using the therapy after a careful screening of patients. Dr. Om Srivastava, a Mumbai-based infectious disease specialist, who had led the trial at one of the centers said a blanket conclusion that plasma therapy doesn’t work is premature.
The trial, he said, only looked at “moderately ill patients” and didn’t include patients in the initial stages of the viral infection. “I think plasma therapy works very well in the early stage, in the first five to seven days. If you select your patients correctly then there is a benefit,” said Dr. Srivastava, adding that there need to be further analysis about comorbidities among patients who received the therapy and how that may have impacted the findings.
But, Dr. Abdul S. Ansari, director of critical care services at Mumbai’s Nanavati Super Speciality Hospital, said he would not use the therapy for mildly ill Covid-19 patients. “For me, one of the takeaway messages from the trial is to avoid plasma therapy for mildly ill patients. I will use it in moderately ill patients only after careful biochemical assessments.”