India will soon roll out clinical trials on 750 hospitalised adult patients using repurposed drugs as part of the next phase of the World Health Organization’s Solidarity trial – Solidarity PLUS.
The trial aims to assess the effectiveness of new drugs in treating hospitalised Covid-19 patients.
The clinical trial will study two drugs which are already in use like Imatinib for treating certain cancers and infliximab used for diseases of the immune system, including Crohn’s disease and rheumatoid arthritis.
The WHO initiated the Solidarity trial in 2020 to estimate the impact of repurposed drugs on reducing deaths in hospitalized Covid-19 patients compared with the existing standard of care. India is among the 52 countries taking part in WHO’s Solidarity PLUS trial.
The WHO Solidarity PLUS Trial aims to evaluate three treatment arms -Artesunate, Infliximab and Imatinib, in addition to the local standard of care.
According to WHO, these drugs were chosen after careful consideration of potential drugs by an independent panel of experts. Based on available data, these drugs were selected for their potential to reduce mortality.
The drugs were donated by their respective manufacturers for the trial, through Letters of Agreement between WHO and the companies. The companies – Ipca, Johnson and Johnson and Novartis, have agreed to support access to the drugs at reasonable prices if they prove to be effective.
Artesunate produced by Ipca, is used to treat malaria. It will be administered intravenously for 7 days, using the standard dose recommended for the treatment of severe malaria.
Imatinib produced by Novartis will be administered orally, once daily, for 14 days. The dose used is the standard maintenance dose, which is at the lower end of the dose that patients with hematological malignancies are given over extended periods.
Infliximab produced by Johnson and Johnson will be administered intravenously as a single dose. The dose used is the standard dose that patients with Crohn’s Disease are given over extended periods.
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