Pharmacy Magazine – The World Health Organization (WHO) has announced the next phase in its Solidarity trial: Solidaritas PLUS will enroll inpatients to test three new drugs in hospitalized COVID-19 patients.
These therapies – artesunate, imatinib, and infliximab – were selected by an independent panel of experts for their potential to reduce the risk of death in hospitalized COVID-19 patients. They are already used for other indications: artesunate is used for severe malaria, imatinib for certain cancers, and infliximab for immune system diseases such as Crohn’s disease and rheumatoid arthritis.
These drugs are donated for trials by their manufacturers.
“Finding more effective and accessible therapies for COVID-19 patients remains a critical need, and WHO is proud to lead this global effort,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.
“I want to thank the participating governments, pharmaceutical companies, hospitals, doctors and patients, who have come together to do this in true global solidarity.”
The Solidarity PLUS trial is a platform trial that represents the largest global collaboration among WHO Member States. It involved thousands of researchers in more than 600 hospitals in 52 countries, 16 more than the first phase of the trial. This allows the trial to assess multiple treatments at the same time using a single protocol, recruiting thousands of patients to produce robust estimates of the drug’s effect on mortality – even a moderate effect.
It also allows new treatments to be added and ineffective treatments to be canceled during the trial period.
Previously, four drugs were evaluated by the trial. The results showed that remdesivir, hydroxychloroquine, lopinavir, and interferon had little or no effect in hospitalized COVID-19 patients.
Through the Solidarity PLUS trial, researchers around the world have the opportunity to use their expertise and resources to contribute to global COVID-19 research.
Artesunat
Manufactured by Ipca, it is used to treat malaria. In the trial, it will be given intravenously for 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 herb Artemisia annua. Artemisinin and its derivatives have been used extensively in the treatment of malaria and other parasitic diseases for more than 30 years, and are considered very safe. The WHO COVID-19 Therapeutic Advisory Group recommends evaluating the anti-inflammatory properties of artesunate.
Imatinib
Manufactured by Novartis, it is used to treat certain cancers.
In the trial, it would be given orally, once daily, for 14 days. The dose used is the standard maintenance dose, which is the lowest dose for patients with hematological malignancies given for a long period of time.
Imatinib is a small molecule tyrosine kinase inhibitor, formulated as an oral chemotherapy drug used to treat certain types of cancer. Experimental and preliminary clinical data suggest that imatinib reverses pulmonary capillary leakage. A randomized clinical trial conducted in the Netherlands reported that imatinib can provide clinical benefit in hospitalized COVID-19 patients, without any safety concerns.
Infliximab
Manufactured by Johnson and Johnson, it is used to treat diseases of the immune system.
In the experiment, it will be given intravenously as a single dose. The dose used is the standard dose given to patients with Crohn’s disease for a long time.
Infliximab is a TNF alpha blocker, a chimeric monoclonal antibody that recognizes human TNF alpha. Anti-TNF biologics have been approved for the treatment of certain autoimmune inflammatory conditions for more than 20 years, demonstrating favorable efficacy and safety in limiting broad-spectrum inflammation, including in the elderly population most clinically susceptible to COVID-19.
Source
WHO’s Solidarity clinical trial enters a new phase with three new candidate drugs https://www.who.int/news/item/11-08-2021-who-s-solidarity-clinical-trial-enters-a-new-phase-with-three-new-candidate-drugs
–
