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India starts enrolling covid-19 patients for test of new drugs

The ICMR said that this being an adaptive protocol, new drugs may be added to the trial or discontinued based on findings from interim analysis and recommendations of the Data Safety Monitoring Board. (REUTERS)Premium
The ICMR said that this being an adaptive protocol, new drugs may be added to the trial or discontinued based on findings from interim analysis and recommendations of the Data Safety Monitoring Board. (REUTERS)

  • In this study, adults recently hospitalized, or already in hospital, with definite moderate or severe covid-19 would be given infliximab as a single IV infusion or two tablets imatinib once a day for 14 days

NEW DELHI : India, which is taking part in the World Health Organization’s (WHO's) Solidarity PLUS trial, has started enrolling hospitalized covid-19 patients to test new drugs imatinib and infliximab for treatment of coronavirus.

The Indian Council of Medical Research (ICMR), through ICMR-National AIDS Research Institute, Pune, is coordinating the trial with at least 15 participating trial sites on over 750 patients. The trial is titled “An international randomized trial of additional treatments for covid-19 in hospitalized patients who are all receiving the local standard of care SOLIDARITY TRIAL PLUS" or “WHO-India (ICMR) SOLIDARITY trial plus".

In this study, adults recently hospitalized, or already in hospital, with definite moderate or severe covid-19 would be given infliximab as a single IV infusion or two tablets imatinib once a day for 14 days. The ICMR said that this being an adaptive protocol, new drugs may be added to the trial or discontinued based on findings from interim analysis and recommendations of the Data Safety Monitoring Board (DSMB).

“The ICMR has also sought maximum of 75 Lakh per occurrence and an aggregate insurance of 20 crore through interested insurance companies. It has sought clinical trial insurance for professional indemnification for 250 investigators physicians and nurses, compensation for ‘Trial related injuries’ for study participants as per New Drugs and Clinical Trials Rules, 2019, and medical management for adverse events related to study drugs and not natural disease progression," said a spokesperson of ICMR. The duration of the study will be 1.5 years (10-12 months of study and post study wrap up).

India is among the 52 countries taking part in the WHO Solidarity PLUS trial that is enrolling hospitalized covid-19 patients to test three new drugs—artesunate, imatinib and infliximab. These drugs are already in use for other conditions. Artesunate is used for severe malaria, imatinib for certain cancers, and infliximab for diseases of the immune system such as Crohn’s disease and rheumatoid arthritis.

Selected by an independent expert panel for their potential in reducing the risk of death in hospitalized covid-19 patients, the drugs were donated for the trial by their manufacturers.

Artesunate, produced by Ipca, will be administered intravenously for seven days, following the standard dose recommended for the treatment of severe malaria. Imatinib, produced by Novartis, will be administered orally, once daily, for 14 days. A randomized clinical trial performed in the Netherlands reported that imatinib might confer clinical benefit in hospitalized covid-19 patients, in the absence of safety issues.

Infliximab, produced by Johnson and Johnson, will be administered intravenously as a single dose. Infliximab is a TNF alpha inhibitor, a chimeric monoclonal antibody that recognizes human TNF alpha. Anti-TNF biologics have been approved for the treatment of certain autoimmune inflammatory conditions for more than 20 years, demonstrating favourable efficacy and safety in restricting broad spectrum inflammation, including in elderly populations who are most clinically vulnerable to covid-19.

The Solidarity PLUS trial is a platform trial that represents the largest global collaboration among WHO member states. The WHO announced the trial earlier this month. It involves thousands of researchers in over 600 hospitals in 52 countries, 16 more countries than the first phase of trials. This allows the trial to assess multiple treatments at the same time using a single protocol, recruiting thousands of patients to generate robust estimates on the effect a drug may have on mortality—even moderate effects.

It also allows new treatments to be added and ineffective treatments to be dropped throughout the course of the trial. Previously, four drugs were evaluated by the trial. The results showed that remdesivir, hydroxychloroquine, lopinavir and interferon had little or no effect on hospitalized patients with covid-19.

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