India has identified four dedicated COVID-19 hospitals at as many high-load Covid-19 cities to be a part of “Solidarity”, the World Health Organisation’s (WHO) international clinical trial to help find an effective treatment for novel coronavirus.
These hospitals are AIIMS in Jodhpur, Apollo Hospital in Chennai, B J Medical College and Civil Hospital in Ahmedabad and Chirayu Medical College and Hospital in Bhopal.
Under the trial, the effectiveness of four drugs and standard care on coronavirus patients will be compared. The four-drug regimes that will be tested on Covid-19 patients under the Solidarity Trial are -Remdesivir, Lopinavir, Hydroxychloroquine or Chloroquine and Interferon.
The international clinical trial has been launched by the WHO and its partners to help find an effective treatment for Covid-19. India is among 100 other countries participating in the trial.
“The Solidarity Trial will compare four treatment options against standard of care, to assess their relative effectiveness against Covid-19,” according to the world health agency.
It aims to rapidly discover whether any of the drugs in the trial slows down disease progression or improves survival. The trial has patients enrolled in multiple countries. “Other drugs can be added based on emerging evidence,” it says.
A scientist from the ICMR said that the research wing body plans “to initiate the trial at 20-25 clinical trial sites in many states across the country”.
“These sites are in various stages of being approved. The sites require approval from their institutional ethics committees, and have to be trained and updated with the Drug Controller General of India (DCGI) and Clinical Trials Registry-India (CTRI). Some sites are already registered, some are close to registration, and many more are in the process of obtaining approval from their ethics committee,” said the scientist.
She said that India will be testing all the four treatment options. Remdesivir, which is exclusively manufactured by Gilead in the US, and Interferon beta-1a, “have been donated by WHO for trial in India.”
“All four treatments will be tested. Patients who are willing to participate and provide their informed consent will be allotted randomly, through a computer programme, to any one of the four treatment options,” she added.
Chloroquine and hydroxychloroquine are very closely related and used to treat malaria and rheumatology conditions respectively. The ICMR has authorised hydroxychloroquine as prophylaxis (preventive treatment), recommending it for healthcare workers and those taking care of COVID-19 patients at home.
Remdesivir is a drug with antiviral properties that was manufactured by a US-based biotechnology company in 2014, to treat Ebola cases; it was also tried in patients of MERS and SARS, both caused by coronaviruses while Lopinavir/ Ritonavir is a licensed treatment for HIV. India first used the Lopinavir/ Ritonavir combination for treatment of an Italian couple who tested positive in Rajasthan. Interferon beta-1a is used to treat multiple sclerosis.
“By enrolling patients in multiple countries, the Solidarity trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence,” as per the WHO website.