October 17, 2020: The interim analysis of World Health Organisation (WHO)'s Solidarity Trial has revealed that four repurposed drugs for COVID-19--remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on reducing mortality, initiation of ventilation and duration of hospital stay, said medRxiv on Friday, a preprint server, and findings are under review for publication in a medical journal.
The trial was conducted from March 22 to October 4. The aim of the study was to see the effects of these treatments on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalised patients.
The mortality findings contain most of the randomized evidence on remdesivir and interferon, and are consistent with meta-analyses of mortality in all major trials.
According to the findings, the trial was undertaken in 405 hospitals in 30 countries and 11,266 adults were randomized, with 2,750 allocated remdesivir, 954 hydroxychloroquine, 1,411 lopinavir, 651 interferon plus lopinavir, 1,412 only interferon, and 4,088 no study drug.
Previously, the trial arms for hydroxychloroquine and lopinavir were discontinued as primarily results had shown no benefit.
"These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay," the study said.
"Other uses of the drugs, for example in treatment of patients in the community or for prevention, would have to be examined using different trials," it said.
Meanwhile, Indian Council of Medical Research (ICMR) also issued a statement on Solidarity Therapeutics Trial, conducted under the aegis of the World Health Organization (WHO) in which it is an active partner.
"The trial tested four repurposed drugs: remdesivir, interferon b1a, lopinavir/ritonavir and hydroxychloroquine. Interim analysis showed that no benefits of Remdesivir in any groups of COVID-19 (asymptomatic /mild / moderate /severe /critical) patients," said ICMR.
ICMR has succeeded in conducting this large randomized controlled study even during a pandemic situation and earlier lockdown. This study reliably answers critical public health questions concerning therapeutics, it said.
Earlier, ICMR conducted PLACID trial for convalescent plasma indicating no benefit of it in COVID treatment.
This was a well-coordinated national effort, led by ICMR-National AIDS Research Institute (NARI), Pune, with Dr Sheela Godbole, Scientist F, at the helm.
"The trial comprised 26 actively randomizing sites with 937 participants in India. We are grateful to the trial participants and their families for contributing to these crucial findings," said Dr Samiran Panda, Head, ICMR-Division of Epidemiology and Communicable Diseases (ECD), and Director, ICMR-NARI.
The Solidarity Trial is the world's largest global randomized controlled trial in a pandemic situation for COVID -19 therapeutics, spanning 30 countries. India contributed one tenth of the participants in the trial, said ICMR.
STORY HIGHLIGHTS
October 17, 2020: The interim analysis of WHO's Solidarity Trial has revealed that four repurposed drugs for COVID-19 appeared to have little or no effect on reducing mortality.
October 17, 2020: The interim analysis of World Health Organisation (WHO)'s Solidarity Trial has revealed that four repurposed drugs for COVID-19--remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on reducing mortality, initiation of ventilation and duration of hospital stay, said medRxiv on Friday, a preprint server, and findings are under review for publication in a medical journal.
The trial was conducted from March 22 to October 4. The aim of the study was to see the effects of these treatments on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalised patients.
The mortality findings contain most of the randomized evidence on remdesivir and interferon, and are consistent with meta-analyses of mortality in all major trials.
According to the findings, the trial was undertaken in 405 hospitals in 30 countries and 11,266 adults were randomized, with 2,750 allocated remdesivir, 954 hydroxychloroquine, 1,411 lopinavir, 651 interferon plus lopinavir, 1,412 only interferon, and 4,088 no study drug.
Previously, the trial arms for hydroxychloroquine and lopinavir were discontinued as primarily results had shown no benefit.
"These remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay," the study said.
"Other uses of the drugs, for example in treatment of patients in the community or for prevention, would have to be examined using different trials," it said.
Meanwhile, Indian Council of Medical Research (ICMR) also issued a statement on Solidarity Therapeutics Trial, conducted under the aegis of the World Health Organization (WHO) in which it is an active partner.
"The trial tested four repurposed drugs: remdesivir, interferon b1a, lopinavir/ritonavir and hydroxychloroquine. Interim analysis showed that no benefits of Remdesivir in any groups of COVID-19 (asymptomatic /mild / moderate /severe /critical) patients," said ICMR.
ICMR has succeeded in conducting this large randomized controlled study even during a pandemic situation and earlier lockdown. This study reliably answers critical public health questions concerning therapeutics, it said.
Earlier, ICMR conducted PLACID trial for convalescent plasma indicating no benefit of it in COVID treatment.
This was a well-coordinated national effort, led by ICMR-National AIDS Research Institute (NARI), Pune, with Dr Sheela Godbole, Scientist F, at the helm.
"The trial comprised 26 actively randomizing sites with 937 participants in India. We are grateful to the trial participants and their families for contributing to these crucial findings," said Dr Samiran Panda, Head, ICMR-Division of Epidemiology and Communicable Diseases (ECD), and Director, ICMR-NARI.
The Solidarity Trial is the world's largest global randomized controlled trial in a pandemic situation for COVID -19 therapeutics, spanning 30 countries. India contributed one tenth of the participants in the trial, said ICMR.