WHO Launches Next Trial Phase to Test COVID-19 Drugs in Patients
The Solidarity PLUS trial will enroll hospitalized patients to test three potential COVID-19 drugs from Ipca, Novartis, and Johnson & Johnson.
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By - The World Health Organization (WHO) recently announced the next phase in its Solidarity trial, Solidarity PLUS, to test new COVID-19 drugs in hospitalized patients.
The trial will enroll patients to test three new therapies, artesunate, imatinib, infliximab. An expert panel selected the drugs for their potential in reducing risk of death in hospitalized coronavirus patients.
Solidarity PLUS is the largest global collaboration among WHO member states, involving researchers in over 600 hospitals in 52 countries, 16 more countries than the first phase of trials.
The trial expansion will allow researchers to test multiple treatments simultaneously in thousands of more patients using a single protocol.
“Finding more effective and accessible therapeutics for COVID-19 patients remains a critical need, and WHO is proud to lead this global effort,” Tedros Adhanom Ghebreyesus, MD, WHO Director-General, said in the announcement.
“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,” Ghebreyesus continued.
Artesunate, produced by Ipca, is currently used to treat malaria. In the trial, researchers will administer the drug intravenously for seven days using the standard dose recommended for severe malaria.
The WHO COVID-19 Therapeutics Advisory Group recommended evaluating the anti-inflammatory properties of artesunate.
Novartis developed a small-molecule tyrosine kinase inhibitor, imatinib, to treat certain cancers.
Early clinical data suggested that imatinib reverses pulmonary capillary leak.
And a randomized trial launched in the Netherlands found that the drug might elicit clinical benefit in hospitalized COVID-19 patients, in the absence of safety issues.
In the Solidarity PLUS trial, patients will receive imatinib once daily for a total of 14 days. The standard maintenance dose for the drug falls at the lower end of the dose patients with hematological malignancies are given over extended periods.
And Johnson & Johnson produced infliximab, a TND alpha inhibitor and chimeric monoclonal antibody to treat immune system diseases.
Anti-TND biologics have elicited benefits in individuals living with certain autoimmune inflammatory conditions for over 20 years. In previous trials, these biologics have demonstrated favorable efficacy and safety in restricting broad spectrum inflammation.
These studies included elderly individuals, the population most vulnerable to COVID-19.
Ipca, Novartis, and Johnson & Johnson donated their treatments to the study as potential COVID-19 drugs.
Previously, researchers evaluated four drugs in the Solidarity trial. The results showed that remdesivir, hydroxychloroquine, lopinavir, and interferon had little or no effect on hospitalized patients with COVID-19.
Through the Solidarity PLUS trial, researchers globally can use their expertise and resources to contribute to global COVID-19 research.
