WHO's Solidarity clinical trial enters a new phase with three new candidate
drugs <https://worldhealthorganization.cmail19.com/t/d-l-aljnc-jyyhckyty-r/>
Solidarity PLUS trial for promising drugs will roll out in 52 countries, an
unprecedented global collaboration for COVID-19 R&D
11 August 2021
Reading time: 2 min (622 words)
The World Health Organization (WHO) has announced the next phase in its
Solidarity trial: Solidarity PLUS will enroll hospitalized patients to test
three new drugs in hospitalized COVID-19 patients.
These therapies - artesunate, imatinib and infliximab ? were selected by an
independent expert panel for their potential in reducing 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 diseases of the immune system such as Crohn?s
Disease and rheumatoid arthritis.
These drugs were donated for the trial by their manufacturers.
?Finding more effective and accessible therapeutics 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 would like to thank
the participating governments, pharmaceutical companies, hospitals,
clinicians 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 involves thousands of
researchers in over 600 hospitals in 52 countries, 16 more countries than
the first phase of trials. This allows the trial to assess multiple
treatments at the same time using a single protocol, recruiting thousands
of patients to generate robust estimates on the effect a drug may have on
mortality--even moderate effects.
It also allows new treatments to be added and ineffective treatments to be
dropped throughout the course of the trial.
Previously, four drugs were evaluated by the trial. The results
<https://worldhealthorganization.cmail19.com/t/d-l-aljnc-jyyhckyty-y/> showed
that remdesivir, hydroxychloroquine, lopinavir and interferon had little or
no effect on hospitalized patients with COVID-19.
Through the Solidarity PLUS trial, researchers across the world have an
opportunity to use their expertise and resources to contribute to global
COVID-19 research.
About the drugs
*Artesunate*
Produced by Ipca, is used to treat malaria. In the trial, it will be
administered 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
extensively used in the treatment of malaria and other parasitic diseases
for over 30 years, and are regarded as being very safe. The WHO COVID-19
Therapeutics Advisory Group recommended evaluating the anti-inflammatory
properties of artesunate.
*Imatinib*
Produced by Novartis, is used to treat certain cancers.
In the trial, 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 patients with haematological malignancies are given over extended
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
leak. A randomized clinical trial performed in the Netherlands reported
that imatinib might confer clinical benefit in hospitalized COVID-19
patients, in the absence of safety issues.
*Infliximab*
Produced by Johnson and Johnson, is used to treat diseases of the immune
system.
In the trial, 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.
Infliximab is a TNF alpha inhibitor, a chimeric monoclonal antibody that
recognizes human TNF alpha. Anti-TNF biologics have been approved for
treatment of certain autoimmune inflammatory conditions for more than 20
years, demonstrating favourable efficacy and safety in restricting broad
spectrum inflammation, including in elderly populations who are most
clinically vulnerable to COVID-19.
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· For more information on the trial, see the trial registry
https://www.isrctn.com/ISRCTN18066414
<https://worldhealthorganization.cmail19.com/t/d-l-aljnc-jyyhckyty-j/>
· For more information about WHO research activities during the
pandemic visit the R&D Blueprint website
https://www.who.int/teams/blueprint/covid-19
<https://worldhealthorganization.cmail19.com/t/d-l-aljnc-jyyhckyty-t/>