New Delhi: Two Indian patients have joined the trials for remdesivir — an experimental drug scientists believe could hold the answer to treating Covid-19 — as India volunteered to participate in the World Health Organization’s Solidarity trial for developing vaccines and testing drugs for the coronavirus.
“I am very happy that India has joined Solidarity trials. First two patients were randomised from India over the last few days … There are now about 11 countries which have started enrolling patients,” Dr Soumya Swaminathan, chief scientist at WHO said in conversation with ThePrint’s Editor-in-Chief, Shekhar Gupta at the digital event Off The Cuff on 25 April.
Given the multi-national efforts going into the trial, which was launched on 18 March, the WHO named it ‘Solidarity’. The trial will compare untested treatment options to assess their effectiveness against Covid-19.
The trial has registered about 1,650 patients from countries such as Indonesia, Malaysia, Philippines, Norway, Italy, Spain, Canada, France and Switzerland. “In fact, Iran has enrolled the majority of patients,” said Dr Swaminathan.
According to the scientist, remdesivir was included in the ongoing trials because “it is a broad spectrum antiviral drug which prevents the replication mechanism of the coronavirus”.
The World Health Organization (WHO) is facilitating access to thousands of treatment courses for the trial through donations from a number of drug manufacturers.
“The greater the number of participating countries, the faster the results will be generated,” WHO said on its website.
Apart from remdesivir, treatment options including anti-HIV drugs lopinavir and ritonavir, lopinavir and ritonavir with Interferon beta-1a, and chloroquine or hydroxychloroquine will be tested.
Due to the pressure Covid-19 has been exerting on health systems across the world, WHO considered the need for speed and scale in conducting trials.
“While randomized clinical trials normally take years to design and conduct, the Solidarity Trial will reduce the time taken by 80 per cent,” WHO said on its website.
“Enrolling patients in one single randomized trial will help facilitate the rapid worldwide comparison of unproven treatments. This will overcome the risk of multiple small trials not generating the strong evidence needed to determine the relative effectiveness of potential treatments,” it said.
Patients are enrolled when those with Covid-19 are admitted to participant hospitals and are willing to join this study. Eligibility is limited to adult patients.
Eligible patients will be asked to sign consent forms to show they understand the possible risks and benefits and consent to joining the study. The medical team responsible for each patient will check whether any of the study treatments would definitely be unsuitable, according to the WHO.
The remdesivir answer
Remdesivir is an investigational broad-spectrum antiviral drug, which is not approved anywhere globally for any use. Manufactured by US company Gilead Sciences, it is currently the subject of at least five trials on coronavirus patients.
“The limited preclinical data on remdesivir in MERS and SARS indicate that remdesivir may have potential activity against COVID-19,” Gilead Sciences stated on its website.
Gilead Sciences’ claim about the drug’s potential efficacy against the disease has been endorsed by WHO.
“There is only one drug right now that we think may have real efficacy, and that’s remdesivir,” said WHO assistant director-general Bruce Aylward at a Beijing press briefing.
According to the UN health body, remdesivir was previously tested as an Ebola treatment. It also generated promising results in animal studies for the Middle East Respiratory Syndrome (MERS-CoV) and severe acute respiratory syndrome (SARS) — both caused by coronaviruses — suggesting it may have some effect on patients with Covid-19.