Solidarity trial

The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness. The trial was announced 18 March 2020, and as of 6 August 2021, 12,000 patients in 30 countries had been recruited to participate in the trial. In May, the WHO announced an international coalition for simultaneously developing several candidate vaccines to prevent COVID-19 disease, calling this effort the Solidarity trial for vaccines. The treatments being investigated are remdesivir, lopinavir/ritonavir combined, lopinavir/ritonavir combined with interferon-beta, and hydroxychloroquine or chloroquine. Hydroxychloroquine or chloroquine investigation was discontinued in June 2020 due to concluding that it provided no benefit. The trial intends to rapidly assess thousands of COVID-19 infected people for the potential efficacy of existing antiviral and anti-inflammatory agents not yet evaluated specifically for COVID-19 illness, a process called "repurposing" or "repositioning" an already-approved drug for a different disease. The Solidarity project is designed to give rapid insights to key clinical questions: Do any of the drugs reduce mortality? Do any of the drugs reduce the time a patient is hospitalized? Do the treatments affect the need for people with COVID-19-induced pneumonia to be ventilated or maintained in intensive care? Could such drugs be used to minimize the illness of COVID-19 infection in healthcare staff and people at high risk of developing severe illness? Enrolling people with COVID-19 infection is simplified by gathering informed consent, and capturing data on an online clinical trial platform (Castor EDC). After the trial staff determine the drugs available at the hospital, the platform randomizes the hospitalized subject to one of the trial drugs or to the hospital standard of care for treating COVID-19.