The World Health Organization is launching a large-scale global clinical trial testing whether a trio of pre-existing drugs can be repurposed to treat those hospitalized with severe COVID-19. The project serves as the second phase of WHO’s Solidarity project, which last year found four common antiviral medications did not help hospitalized COVID-19 patients.
In March last year, within weeks of the initial global spread of SARS-CoV-2, the WHO announced a massive international trial testing several pre-existing antiviral drugs as potential treatments for COVID-19. Dubbed Solidarity, the world’s largest randomized controlled trial on COVID-19 therapeutics tested four drugs: remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon.
By the time the research concluded late in 2020, it had encompassed 405 hospitals across 30 countries and recruited over 11,000 participants. All four antiviral treatments tested were found to have little to no effect on overall mortality or duration of hospital stay.
Now the WHO has kicked off the second phase of its global research program, named Solidarity Plus. This project will investigate three pre-existing drugs – artesunate, imatinib and infliximab.
Last year, as we learned more and more about this novel virus and the disease it causes, an old immunosuppressive drug called dexamethasone was turning out to be the most useful pre-existing drugs to help severe COVID-19 patients.
It was discovered that when hospitalized patients begin to rapidly deteriorate it is due to the body’s natural immune defenses overreacting and triggering respiratory failure. So if an immunosuppressive drug can be administered at precise times before hospitalized patients really decline, then lives can be saved.
Importantly, these drugs do not help patients at earlier stages of disease. In fact, if immunosuppressive drugs are administered too early in the course of the disease it can make things much worse.
All three drugs being trialed share anti-inflammatory properties but act in very different ways. Infliximab, for example, is a monoclonal antibody treatment designed to inhibit an inflammatory protein called tumor necrosis factor alpha. It is commonly used to treat Crohn’s disease and rheumatoid arthritis.
Imatinib is a cancer drug known as a small molecule tyrosine kinase inhibitor, and artesunate is an anti-malarial drug with known anti-inflammatory effects.
Infliximab and artesunate are both intravenously delivered drugs, while imatinib is an oral medication. The trial is designed to run alongside local standard of care in any given region, and patients enrolled will be randomly allocated one of the interventions soon after initial admission with a positive COVID-19 diagnosis.
The new phase of Solidarity will be bigger than its 2020 predecessor, this time encompassing 600 hospitals across 52 countries. The project aims to enroll over 14,000 patients over the coming weeks and months.
“Finding more effective and accessible therapeutics for COVID-19 patients remains a critical need, and WHO is proud to lead this global effort,” says Director-General of the WHO, Tedros Adhanom Ghebreyesus. “I would like to thank the participating governments, pharmaceutical companies, hospitals, clinicians and patients, who have come together to do this in true global solidarity.”
Source: WHO
