In a jolt to doctors managing Covid-19 patients, a WHO-supported international trial on Friday reported that none of the four repurposed medicines to treat Covid-19 including Remdesivir and Hydroxychloroquine actually helps reduce the 28-day mortality rate in hospital.
The medicines, Remdesivir, Hydroxychloroquine, Lopinavir (fixed-dose combination with Ritonavir) and Interferon, appeared to have little or no effect on hospitalised Covid-19 patients as indicated by overall mortality, initiation of ventilation and duration of hospital stay, concluded the WHO Solidarity trial consortium that includes researchers from 30 countries including India and was led by WHO chief scientist Soumya Swaminathan.
All the four medicines were originally meant for treating some other disease, but were repurposed for Covid-19 on the basis of a few laboratory studies and anecdotal evidence. In the absence of any medicine, doctors began using them and got mixed results.
As their usage expanded, the World Health Organisation decided to test the four regimen’s efficacy in a randomized control trial.
In 405 hospitals in 30 countries as many as 11,266 adults participated in the trial with 2,750 individuals receiving Remdesivir, 954 Hydroxychloroquine, 1,411 Lopinavir, 6,51 Interferon plus Lopinavir, 1,412 only Interferon, and 4,088 no drug.
The aim was to see if these medicines help reduce mortality in hospitalized patients after 28 days.
Two arms of the trial involving Hydroxychloroquine and Lopinavir were discontinued much before the closure of the study period as they were found useless. At the end of the trial, other two regimens were also found to be of no use.
“It has been decided to discontinue the interferon arm as its continued use is verging on the harm. The use of Remdesivir, however, would continue for some more time to see if there is any benefit in a few more subsets. But one thing is clear – the medicine has no benefit to improve mortality in Covid-19 patients,” K Srinath Reddy, president of the Public Health Foundation of India and one of the coauthors of the Solidarity trial study told DH.
Remdesivir was approved by the US Food and Drug Administration against Covid-19 on the basis of a US study, whose trial objectives were changed mid-course.
While the initial study was designed to check the medicine’s efficacy, it was decided later to change track and see whether the medicine would shorten the hospital stay for a Covid-19 patient. Carried out on 1,000 patients, the US study too demonstrated no effect on mortality.
India was an active participant in all the four arms of the solidarity trial with the involvement of 937 participants at 26 sites. “The interim results show that no study drug definitely reduced mortality or initiation of ventilation in hospitalized Covid-19 patients,” said ICMR director general Balram Bhargava.
While the study is yet to be published in a peer reviewed journal, a pre-print has been released disclosing the results.