ICMR is Setting up Trial Sites for WHO ‘Solidarity’ Programme

Indian Council of Medical Research (ICMR) is busy setting up clinical trial sites and enrolling COVID-19 patients as part of its efforts to contribute to the much-hyped, WHO-led ‘solidarity trial’, which envisages comparing the effectiveness of various medicines and drug cocktails against the pandemic based on results collated from participating countries.

ICMR is India’s apex body for biomedical research.

“Currently we are in the process obtaining all the regulatory approvals like those from the Drugs Controller General of India and the Institutional Ethics Committees,” said Dr Sheela Godbole, Principal Investigator of the ‘Solidarity Trials’ in India, offering the latest updates about India’s proposed participation in these trials. She did not disclose details about the sites chosen for the trials. Dr Godbole is a scientist at ICMR’s National AIDS Research Institute (NARI), Pune.

The ‘Solidarity’ programme, according to WHO’s own definition, is an international clinical trial by the organization and its partners to help find an effective treatment for COVID-19. The WHO website says, “The Solidarity trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival.” A section of the media has erroneously reported that India had already joined the ‘Solidarity’ trials.

Some weeks ago, ICMR’s chief epidemiologist Dr Raman Gangakhedkar, now a familiar face on TV, had announced that India would join the WHO-steered trials. The trials will be done across four categories: Remdesivir; Lopinavir/Ritonavir; Lopinavir/Ritonavir with Interferon Beta, and Hydroxychloroquine. Remdesivir is an anti-viral drug manufactured by Gilead Sciences Inc to treat Ebola. Lopinavir/Ritonavir is a combination drug for the treatment and prevention of HIV/AIDS. In the absence of any approved treatments for MERS, a combination of Lopinavir, Ritonavir and Interferon Beta is commonly used to treat the viral disease. Hydroxychloroquine is an anti-malarial drug. All these combinations are being tried by hospitals around the world to save lives from COVID-19 on a compassionate basis.

Once ICMR secures all required approvals, the WHO will ship all drugs and combinations to India. While most others are already stocked here, Remdesivir is not sold in India. Open had earlier carried a report quoting an American health-oriented website how COVID-19 patients who were being treated with Remdesivir “in a closely watched clinical trial” saw “rapid recoveries” in fever and respiratory symptoms. The report also said nearly all patients in this trial were discharged in less than a week, signalling that the Gilead drug could become the first approved treatment to fight the COVID-19 pandemic. “It is based on video footage and is not yet published in a scientific journal. If rightly reported, the news is certainly encouraging. It however does not seem to be a randomised trial with a control arm,” Dr Godbole told Open. She added, “The WHO Solidarity trial is one of a few other clinical trials where Remdesivir is being tested in a randomized controlled clinical trial setting.”

ICMR has already given approvals to four proposals from the Kerala government to fight COVID-19. The state secured ICMR’s nod for its protocol for a convalescent serum therapy, which involves using the blood plasma of Covid-19 patients to treat new cases. ICMR had also granted approval for the state’s plans to acquire Interferon Alpha, do a seroprevalence study to verify community transmission, and monitor acute respiratory infections. Interferon Alpha, popularly known as the ‘Cuban wonder drug’, is an inhalational drug while Interferon Beta is a drug in injectable form.

Open had reported earlier that this seroprevalence study entails doing antibody tests to detect if someone had been infected with COVID-19 without being aware of it. If the random trials establish any such case, it means that community spread has already occurred in the area where antibodies to SARS-COV-2 virus were found in a person’s blood. This test is called “serological enzyme-linked immunosorbent assay”, also called ELISA. The report also said that scientists at the Achutha Menon Centre for Health Science Studies at Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, will monitor any marked rise in pneumonia or respiratory infections across the state thanks to ICMR’s approval. All these results will be shared to a main centre through phone apps.

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