Tamil Nadu has been co-opted into a multi-centric, randomised, emergency ‘Solidarity Trial’ to help identify treatment options for COVID-19 patients. Two centres — the Tamil Nadu Government Multi Super Speciality Hospital, Omandurar Estate, and the Rajiv Gandhi Government General Hospital — have been chosen for the purpose.
The study has four treatment arms, including Remdesivir, Hydroxychloroquine, Lopinavir with Ritonavir (anti-retrovirals), and Lopinavir with Ritonavir and Interferon Beta 1a, according to a letter written to the State government by Sheela Godbole, national co-ordinator, Solidarity-India. The trial programme has been developed to “fast-track the generation of quality global data to help identify treatment options for the COVID-19 disease”.
The drugs would be administered to critical patients, according to sources in the Health Department. The drugs are not meant for asymptomatic patients, according to a source, and there are certain prescriptions that the Indian Council of Medical Research (ICMR) has specified, which will be followed by the principal investigators of the study in Chennai. Remdesivir and Interferon will be shipped from the ICMR-National AIDS Research Institute, while the State will have to procure the other drugs.
The principal investigators and co-investigators in the two chosen institutions to co-ordinate the trial have also been identified, it is learnt. “We are ready to start as soon as the drugs arrive, possibly in a week’s time,” a Health Department official told The Hindu.
The criteria for patient enrolment on the Clinical Trials Registry of India (CTRI) are adults aged 18 or above; those not receiving any of the study drugs already; and people without known allergy or contraindications to any of the study drugs. They should not be transferred from the hospital to a non-study hospital within 72 hours. Patients with chronic liver or heart disease or any kind of concurrent medication, pregnant women and those who do not wish to participate in the study cannot be recruited.
“There are currently no available vaccines or treatments for COVID-19. Although there have been some suggestions for untested treatments that could be added to the usual care in hospitals, none has been known to help. The World Health Organisation is, therefore, organising a study in many countries, in which some of these untested treatments are compared with each other to discover whether any [of them] do help. The study treatments are Remdesivir, Hydroxychloroquine, Lopinavir plus Ritonavir, and Interferon-beta. Some are given as daily pills, and some as daily injections,” according to the CTRI website.
Meanwhile, the State is also scheduled to start a trial to determine the effectiveness of using convalescent plasma in the treatment of COVID-19. Four institutes — the Government Multi Super Speciality Hospital, Omandurar Estate, and the Rajiv Gandhi Government General Hospital in Chennai, and the government hospitals in Tirunelveli and Madurai — will be the centres for the trial, sources in the Health Department said.