Updated: October 16, 2020 7:46:49 pm
“Solidarity” is an international initiative for clinical trials launched by the WHO, together with its partners, to help find an effective treatment for Covid-19. (Representative image / AP)
The World Health Organization (WHO) released on Thursday (October 15) the interim results of the Solidarity Therapeutics Trial, the world’s largest randomized control trial of Covid-19 therapies, involving more than 11,300 people in 405 hospitals in 30 countries around the world.
The massive trial “has generated conclusive evidence on the effectiveness of repurposed drugs for the treatment of Covid-19,” the WHO said in an official statement.
What do the provisional results of the Solidarity trial indicate?
Results from the trial, which was coordinated by WHO, indicate that none of the four reused drug regimens have an impact on the mortality of severely ill Covid patients.
The document ‘Antiviral Drugs Repurposed for COVID-19; interim results from the WHO SOLIDARITY ‘trial, uploaded as preprint on medRxiv, concludes: “These regimens of Remdesivir, Hydroxychloroquine, Lopinavir, and Interferon appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, baseline of ventilation and duration of hospital stay. The mortality findings contain most of the randomized evidence for Remdesivir and Interferon, and are consistent with the mortality meta-analyzes in all the main trials. “
The results of the trial are under review for publication in a medical journal, the WHO said.
What exactly is the Solidarity Trial?
“Solidarity” is an international initiative for clinical trials launched by the WHO, together with its partners, to help find an effective treatment for Covid-19. The multi-cluster / country trial looked at four drugs or drug combinations: remdesivir, hydroxychloroquine (HCQ), ritonavir / lopinavir, and lopinavir / ritonavir / interferon beta 1a.
The trial of the HCQ arm was halted for a time in May after the WHO announced it would no longer assign patients after a study published in The Lancet medical journal cast doubt on the safety of the malaria drug in Covid patients. -19. . The Lancet subsequently retracted the study and apologized.
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According to the WHO, “the [Solidarity] study, covering more than 30 countries, analyzed the effects of these [four kinds of] Treatments on overall mortality, onset of ventilation, and length of hospital stay in hospitalized patients. Other uses of the drugs, for example in treating patients in the community or for prevention, should be examined through different trials. “
India was one of the countries where the Solidarity Trial took place. Four hospitals in Jodhpur, Ahmedabad, Chennai and Bhopal received the first regulatory approvals for the trial.
WHO had previously said that “by enrolling patients in multiple countries, the Solidarity Trial aims to quickly discover whether any of the drugs slows disease progression or improves survival. Other medications may be added based on emerging evidence …
“More than 400 hospitals in 35 countries are actively recruiting patients and nearly 3,500 patients have been enrolled from 17 countries. Overall, more than 100 countries have joined the trial or expressed interest in doing so, and WHO is actively supporting 60 of them, ”he said in a statement this summer.
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How did the other branches of the judgment proceed?
The remdesivir arm was widely described for many weeks as the most promising, although the results sometimes seemed contradictory. Developed by Gilead Sciences Inc, remdesivir is a broad-spectrum antiviral that was previously tested in humans with Ebola virus disease and has also shown promise as a drug against MERS and SARS, both caused by coronavirus.
The other two arms (in addition to HCQ and remdesivir) treated with a combination of the drugs ritonavir and lopinavir, and one arm tested the combination along with an additional substance, interferon beta 1a, which belongs to a class of substances known as cytokines that They are secreted by immune cells to signal other cells to act against an acute or impending infection.
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Ritonavir and liponavir are second-line anti-HIV drugs, known as HIV protease inhibitors, that have been used for some time. They strengthen the immune system, which reduces the chances that an HIV positive person will develop complications such as tuberculosis.
So what is the conclusion of the trial?
Essentially, no drug or combination of the four (remdesivir, HCQ, lopinavir, interferon, or interferon plus lopinavir) reduces mortality in Covid-19 patients. The trial has not provided conclusive evidence that these drugs reduce the chances that ventilation is required or that the time in hospital is reduced, compared to patients who were not treated with these drugs.
The study authors have called the results “unpromising.” Although not entirely unexpected, their findings are a serious blow to countries like India where both remdesivir and HCQ are part of the routine anti-Covid-19 drug regimen.
As of Friday (October 16) afternoon, 11 lakh people had died from Covid-19 around the world. The United States and India, the two countries with the highest number of cases, had more than 1.53 million infected people between them; however, the number of deaths in the US (2.17 lakh) was much higher than in India (1.12 lakh).
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