WHO’s clinical trial Solidarity is entering a new phase with three new candidate drugs

The World Health Organization (WHO) has announced the next phase of its solidarity trial: Solidarity PLUS will enroll hospitalized patients to test three new drugs in hospitalized patients with COVID-19.

These therapies – artesunate, imatinib and infliximab – were selected by an independent expert body because of their potential in reducing the risk of death in hospitalized patients with COVID-19. They are already used for other indications: artesunat is used for severe malaria, imatinib for certain cancers, and infliximab for immune system diseases like Crohn’s disease and rheumatoid arthritis.

These drugs were donated by the manufacturers for testing.

“Finding more effective and affordable therapies for patients with COVID-19 remains a critical need, and the WHO is proud to lead this global effort,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “I would like to thank the participating governments, pharmaceutical companies, hospitals, clinicians and patients who have come together in true global solidarity.”

The Solidarity PLUS experiment is the platform that represents the largest global cooperation among WHO member states. It involves thousands of researchers in more than 600 hospitals in 52 countries, 16 countries more than the first phase of the study. This allows the study to evaluate multiple treatments at the same time using a single protocol, recruiting thousands of patients to generate reliable estimates of the drug’s effect on mortality — even moderate effects.

It also allows the addition of new treatments and the rejection of ineffective treatments during testing.

Earlier, four drugs were evaluated in the study. The results showed that remdesivir, hydroxychloroquine, lopinavir, and interferon had little or no effect on hospitalized patients with COVID-19.

Through the Solidarity PLUS survey, researchers around the world have the opportunity to use their expertise and resources to contribute to the global COVID-19 research.

About drugs

Artesunate
Produced by Ipca, it is used to treat malaria. In the study, it will be administered intravenously over 7 days, using the standard dose recommended for the treatment of severe malaria.

Artesunate is a derivative of artemisinin, an antimalarial drug extracted from the plant Artemisia annua. Artemisinin and its derivatives have been widely used in the treatment of malaria and other parasitic diseases for more than 30 years and are considered very safe. The WHO Advisory Group for COVID-19 Therapy recommended an assessment of the anti-inflammatory properties of artesunate.

Imatinib

Manufactured by Novartis, it is used to treat certain types of cancer.
In the study, it 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 given to patients with haematological malignancies over longer periods.

Imatinib is a small molecule tyrosine kinase inhibitor, formulated as an oral chemotherapy drug used to treat certain types of cancer. Experimental and early clinical data suggest that imatinib reverses pulmonary capillary leakage. A randomized clinical trial conducted in the Netherlands reported that imatinib could bring clinical benefit in hospitalized patients with COVID-19, in the absence of safety issues.

Infliximab

It is produced by Johnson and Johnson and is used to treat diseases of the immune system.
In the study, it will be administered intravenously as a single dose. The dose used is the standard dose that Crohn’s disease patients receive over long periods of time.