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Covid-19: Results from India’s 12 molnupiravir clinical trials remain unpublished

BMJ 2022; 378 doi: https://doi.org/10.1136/bmj.o2063 (Published 19 August 2022) Cite this as: BMJ 2022;378:o2063
  1. Elisabeth Mahase
  1. The BMJ

The results of 12 clinical trials conducted in India looking at the efficacy of molnupiravir —an antiviral drug for covid-19—have not been published a year after completion, researchers have said.

Researchers from St George’s, Imperial College London, and the University of Liverpool looked at the availability of data from these trials as of July 2022 for a study released as a preprint.1 They found that, while some details of the findings had been revealed through press releases or conference abstracts, none of the results had been published in a journal or preprint service. This equates to missing data for 13 694 trial participants.

“Patient level data would help answer many of the unanswered questions around the molnupiravir trials; however, even summary data are largely absent,” the authors wrote.

In particular, questions remain over the efficacy of the drug. In October 2021, the MOVe-OUT trial first reported that it halved the risk of hospital admission or death by 50%, but when the full results were published in December 2021 they showed that hospital admissions and deaths were only around 30% lower in the molnupiravir group.2

Molnupiravir is a slightly modified version of a compound developed by Emory University in the US in 2003. During the pandemica it was tested as a covid-19 treatment and acquired by Merck Sharp and Dohme, who gave Indian manufacturers permission to produce the drug through voluntary licensing agreements in 2021. The Indian Central Drugs Standard Control Organisation went on to approve 12 molnupiravir trials, two of which were stopped early.

The UK was the first country to approve molnupiravir. In November 2021 the Medicines and Healthcare Products Regulatory Agency gave a temporary authorisation for the treatment of mild to moderate covid-19 in adults with at least one risk factor for severe illness.3

Meanwhile, in India the Council of Medical Research left molnupiravir off its January 2022 list of recommended covid-19 treatments.4

In response to the study’s findings, Till Bruckner, founder of TranspariMED, a non-profit organisation working to end evidence distortion in medicine, said, “Lawmakers worldwide urgently need to wake up and make it a legal requirement to publish all clinical trial results, without exceptions, as the UK is currently doing.”

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