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WHO Solidarity Trial: An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care

“SOLIDARITY” is an international clinical trial of an investigational medicinal product as required under Directive 2001/20/EC and SI 190 of 2004, to determine safety and efficacy of a range of investigational medicinal products in the treatment of COVID-19. This is a WHO trial aimed at saving lives in a global public health and economic crisis (pandemic). By enrolling patients in multiple countries, the SOLIDARITY trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.
The primary objective of this large international randomised trial is to provide reliable
estimates on the efficacy and safety of these treatments on in-hospital mortality. The secondary
objectives are to assess the impact on hospital duration and the requirement for mechanical ventilation
or intensive care therapy. No specific sample size is specified for the SOLIDARITY trial due to the nature of the public health emergency.