India will roll out this month the next phase of the World Health Organization’s Solidarity trial – Solidarity PLUS – which aims to assess the effectiveness of new drugs in treating hospitalised Covid-19 patients.
The India trial will study two drugs – Imatinib and Infliximab – which are already in use for other conditions. Imatinib is used for treating certain cancers while infliximab is used for diseases of the immune system, including Crohn’s disease and rheumatoid arthritis.
“The trials are likely to begin soon as we have received the drugs,” said a senior official, adding that it would be sometime this month.
India is among the 52 countries taking part in WHO‘s Solidarity PLUS trial. This collaboration for Covid-19 research is also studying the effectiveness of another drug – Artesunate, which is used for treatment of severe malaria. The trials in some other countries will include this third drug.
“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 WHO had earlier said as it shortlisted the drugs. Novartis‘ Imatinib is used to treat certain cancers. It will be administered orally, once daily, for 14 days.
Infliximab, produced by Johnson and Johnson, is used to treat diseases of the immune system. It 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. “The drugs were donated by their respective manufacturers for the trial through letters of agreement between WHO and the companies,” WHO said. “The companies – Johnson and Johnson and Novartis – have agreed to support access to the drugs at reasonable prices if they prove to be effective.”
In India, the trial is expected to be done on some 750 adult patients who are in hospital with definite moderate or severe form of Covid-19, the disease caused by the SARS-CoV-2 virus. The duration of the study will be 18 months.
The WHO initiated the Solidarity trial in 2020 to estimate the impact of repurposed drugs on reducing deaths in hospitalised Covid-19 patients compared with the existing standard of care.