According to the WHO website, the Solidarity trial “will compare four treatment options against the standard of care, to assess their relative effectiveness against COVID-19”.
FOUR COVID-19 treatment centres, in Jodhpur, Ahmedabad, Chennai and Bhopal, have received regulatory approvals for taking part in “Solidarity” — the World Health Organisation’s (WHO) international clinical trial to help find an effective treatment for novel coronavirus — and more are set to follow.
Confirming this, Dr Sheela Godbole, Head, Division of Epidemiology, ICMR-National AIDS Research Institute, and National Coordinator of the WHO-India Solidarity Trial, told The Indian Express that the ICMR plans “to initiate the trial at 20-25 clinical trial sites in many states across India”.
“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,” she said.
The four which have been cleared so far are from cities that have reported a high case load: AIIMS in Jodhpur, Apollo Hospital in Chennai, B J Medical College and Civil Hospital in Ahmedabad and Chirayu Medical College and Hospital in Bhopal. The case count so far is 842 in Jodhpur, 2,644 in Chennai, 4,991 in Ahmedabad, and 605 in Bhopal.
According to the WHO website, the Solidarity trial “will compare four treatment options against the standard of care, to assess their relative effectiveness against COVID-19”.
The treatment options that have been selected are: Remdesivir; Lopinavir/ Ritonavir; Lopinavir/ Ritonavir with Interferon beta-1a; and Chloroquine or Hydroxychloroquine.
“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,” says the WHO website.
Dr Godbole confirmed 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,” she said.
“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,” Dr Godbole said.
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.
In China and France, small studies provided some indications of the possible benefit of chloroquine phosphate against pneumonia caused by COVID-19, but they need confirmation through randomised trials, the WHO has said.
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.
On May 1, the United States Food and Drug Administration (USFDA) authorised the emergency use of Remdesivir as an experimental drug to treat severe cases of COVID-19 who are hospitalised and need oxygen or ventilators.
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.
However, WHO has said that while there are indications from laboratory experiments that this combination may be effective, “studies done so far in COVID-19 patients have been inconclusive.”
Interferon beta-1a is used to treat multiple sclerosis.
The WHO website says that “over 100 countries are working together to find effective therapeutics as soon as possible, via the trial”. According to sources, the countries that have already enrolled in the multi-arm trial include Argentina, Brazil, Canada, Germany, Indonesia, Iran, Norway, Peru, Qatar, South Africa, Spain, Switzerland and Thailand.