Apex medical research body ICMR has said that 9 hospitals have so far been approved to conduct randomised controlled clinical trials under the WHO’s ‘Solidarity Trial’ to find an effective treatment for the novel coronavirus disease.
Four treatment protocols — Remdesivir, a combination of Lopinavir and Ritonavir, Hydroxychloroquine, and Lopinavir and Ritonavir with Interferon beta-1a — will be evaluated during the clinical trials across the selected hospitals, which include the AIIMS in Jodhpur, Apollo Hospital in Chennai, the Ahmedabad-based B J Medical College and Civil Hospital, and the Chirayu Medical College and Hospital in Bhopal.
“The required regulatory and ethical approvals have already been obtained and the trial has begun with recruiting COVID-19 patients in the country. Till now, nine hospitals have been approved. The plan is to enroll at least 20 to 30 clinical sites across India,” said Dr Sheela Godbole, head of the Epidemiology division at the ICMR-National AIDS Research Institute.
She is also the national coordinator for the World Health Organization’s ‘Solidarity Trial’ in India.
The Indian Council for Medical Research (ICMR) has fast tracked the roll out of the global ‘Solidarity Trial’ launched by the WHO to help find an effective treatment for COVID-19, the apex health research body said in a statement.
‘Solidarity’ is an international clinical trial to compare four treatment options against standard of care to assess their relative effectiveness against the coronavirus.
By enrolling patients in multiple countries, the ‘Solidarity Trial’ aims to rapidly discover whether any of the drugs slows the disease’s progression or improve survival.
Importantly, this initiative provides for both speed and scale, the statement said. Speaking about India’s participation in the global endeavour, Dr Balram Bhargava, secretary at the Department of Health Research and Director General ICMR, said the health research body is working relentlessly to implement scientific interventions to combat the COVID-19 pandemic.
“The decision to join the WHO ‘Solidarity Trial’ is an important step in this endeavour. The ICMR-National AIDS Research Institute is the national coordination site for the trial in India.
Four potential anti-viral agents, Remdesivir, Chloroquine/Hydroxychloroquine, Lopinavir-Ritonavir and Lopinavir-Ritonavir with Interferon (beta-1a) are to be evaluated in the trial,” he said.
“We want as many patients to be quickly enrolled in the randomised controlled clinical trial so that results also can come out as soon as possible,” Godbole said.
However, the sample size has to be at least 1,500 in total from all clinical sites.
Welcoming India’s participation in the WHO global trial, Dr Henk Bekedam, WHO representative to India, said, “We congratulate the government of India, particularly the ICMR, for joining the global ‘Solidarity Trial’.”
“Through this collaboration, Indian researchers and institutions will participate in a global initiative to find effective treatment options for COVID-19,” he said.
“India plays a critical role in both research as well as in manufacturing once trials conclude successfully. WHO India is extending the required support to conduct the trial in India,” Bekedam said.
The ‘Solidarity Trial’ provides simplified procedures to enable even overloaded hospitals to participate.