India will be recruiting at least 1500 patients in about 30 hospitals across the country for the World Health Organisation’s (WHO) global solidarity trial for treatment of the coronavirus disease (Covid-19).
The Indian Council of Medical Research (ICMR), which is coordinating trials on behalf of the country has already begun fast-tracking the process of recruiting patients for the multi-country trial to compare four treatment options to assess their relative effectiveness against Covid-19.
The trials include four potential anti-viral drugs, remdesivir, chloroquine/hydroxychloroquine, lopinavir-ritonavir and lopinavir-ritonavir with interferon (β1a). By enrolling patients in multiple countries, the trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival.
“Right now, we are really following the numbers, so the trial sites will be in areas from where most cases are being reported. Nine of the sites have already been approved and four more sites are very close to being approved. Though 1500 patient is the initial number, there is no cap and we can always recruit more patients for the trial, if required,” said Dr Sheela Godbole, head, division of epidemiology, ICMR-National AIDS Research Institute (NARI), which is the nodal centre for coordinating the trials in India.
“Fast-tracking means trying to add as many sites as possible in a short span of time, and at the same time complying will all the local ethical and other regulations meant for such researches. The ethics committees are minutely looking at each application and approvals are being given after due diligence. Just because we are fast-tracking the process does not mean we will be compromising on quality,” she added.
{{/usCountry}}“Fast-tracking means trying to add as many sites as possible in a short span of time, and at the same time complying will all the local ethical and other regulations meant for such researches. The ethics committees are minutely looking at each application and approvals are being given after due diligence. Just because we are fast-tracking the process does not mean we will be compromising on quality,” she added.
{{/usCountry}}On March 28, ICMR announced that India will be participating in the WHO Solidarity trial, for which over 100 countries have requested participation to find effective therapeutics as soon as possible, via the trial.
“The participation of multiple clinical trial units or hospitals in multiple countries will ensure adequate enrolment of participants in the shortest possible time. This will help fast-track identification of correct treatment options for the Covid-19 disease,” said ICMR in a statement.
However, patients who give their consent to participate in the trial will not get to choose which arm of the trial they become a part of. It will be a randomized allocation of medicines for patients. All drugs to be tried in the trials, except for remdesivir, have already been in use in India for various other health conditions.
“It is meant to see how the medicines behave in early stages of disease and what is the effect as the disease progresses,” said Dr Godlbole.
“The results will be based on global enrollment, meaning the data from patients recruited from all countries will be analysed to reach a conclusion. It won’t be based on only what the results were among Indian patients. It will take some time,” she added.