Meanwhile, a multi-center study funded by the Indian Council for Medical Research (ICMR) has found that the use of convalescent plasma therapy in coronavirus-infected patients does not help reduce mortality or progression to severe Covid-19. The ‘open parallel arm phase II multicenter randomized controlled trial’ (PLACID trial) was conducted in 39 public and private hospitals in India between April 22 and July 14 to investigate the efficacy of convalescent plasma (PC ) for the treatment of COVID. -19, it said. Convalescent plasma (CP) therapy involves taking antibodies from the blood of a person who has recovered from COVID-19 and transfusing those antibodies into an active coronavirus patient to help reactivate the immune system to fight infection. A total of 464 participants (moderately ill COVID-19 patients admitted to hospitals) were enrolled for the study, which has not yet been peer-reviewed and has appeared on medRxiv, a preprint server.
The National Working Group for COVID-19, a committee formed by the ICMR to respond to the pandemic, has reviewed and approved this study, he said. The Clinical Management Protocols for COVID-19 issued by the Union Ministry of Health on June 27 allowed the use of convalescent plasma (off-label) for the treatment of patients infected by coronavirus in a moderate stage of the disease under ” investigational therapies “. This authorization has been paralleled by questionable practices such as donor calls on social media and the sale of PCs on the black market at exorbitant prices in India, according to the study.
Additionally, although CP is a safe therapeutic modality, plasmapheresis, plasma storage, and NAb measurement are resource-intensive processes, and a limited number of institutes in the country have the capacity to perform these activities with quality assurance. . “CP was not associated with reduced mortality or progression to severe COVID-19,” the study said, adding that this trial is highly generalizable and approximates the real-life setting of CP therapy in environments with limited laboratory capacity. A prior measurement of neutralizing antibody titers in donors and participants may further clarify the role of PC in managing COVID-19, he said.
The study trial included 464 moderately ill coronavirus-infected hospitalized patients, of whom 235 received convalescent plasma along with best standard care, while 229 received only standard care, according to the study. Those in the intervention arm received two 200 ml doses of CP, transfused 24 hours apart, in addition to the BSC (best standard of care). The two units of plasma were preferably collected from different donors depending on ABO availability and compatibility to increase the chances of receiving CP with NAb, he said. “Results from the PLACID trial 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 central implementation team at the ICMR was responsible for study design, study coordination, data analysis, data interpretation, and report writing, depending on the study. Patient enrollment, data collection and actual conduct of the study were done in public and private hospitals independently, and ICMR researchers had no role in this, he added.
Convalescent plasma (CP) as a passive source of neutralizing and immunomodulatory antibodies is a centuries-old therapeutic option used for the management of viral diseases. According to the study, only two randomized controlled trials on PC use in COVID-19 have been published, one in China and one in the Netherlands.
Both were stopped prematurely, the China study due to inadequate patient enrollment and the Netherlands study due to the need to redesign the trial based on interim findings. In both studies, no mortality benefit was seen, and the Dutch study generated uncertainties regarding the antibody status of patients prior to transfusion as a potential factor in identifying suitable candidates for PC therapy.
This uncertainty in published evidence is reflected in a recent systematic review, which remained undecided on both the safety and effectiveness of CP as a therapeutic option in hospitalized patients for COVID-19. Meanwhile, CP therapy has received regulatory approval for use in patients in different countries. This has led to its widespread adoption in real-world clinical practice, where it is used to treat COVID-19 patients with a broad spectrum of disease severity.
“Given these uncertainties, we conducted the current study to determine the effectiveness of PC use in moderately ill COVID-19 patients admitted to hospitals across India to limit progression to severe disease and determine adverse effects associated with short term, “the study said. All participants or their family members or legally authorized representatives received information about the trial in a language they were comfortable with, and written informed consent was obtained prior to recruitment of the participants, she said.
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