Shortly after the multi-country outbreak of Monkeypox was declared, on 2-3 June 2022, the international scientific community, coordinated of the World Health Organization (WHO), met to identify knowledge gaps and research priorities. The experts concluded that since data on antivirals are only available from animal models, with remaining uncertainties about their efficacy, particularly against monkeypox, randomised trials with standard of care controls can be done, are needed, and are ethical. This led to the development of the CORE protocol for an international multi-country adaptive clinical trial to assess the safety and efficacy of treatments for monkeypox patients.
Following the declaration of the smallpox epidemic as a public health emergency of international concern, researchers and stakeholders around the world, in collaboration with the WHO R&D Blueprint for epidemics, are working to enhance the implementation of outbreak response actions and to coordinate the implementation of research priorities as an important component of the response.
ANRS | Emerging Infectious Diseases, the National Institute for Biomedical Research (INRB) in the Democratic Republic of Congo, and US NIAID/NIH, in collaboration with the WHO R&D Blueprint for epidemics, organised two consultations in June and July 2022, bringing together more than 500 experts to develop a common protocol. This CORE protocol is the result of these consultations and of the deliberations of several individual experts and various expert groups, including those coordinated by the WHO, in the spirit of a truly collaborative effort.
The core protocol developed will allow for the development of an international adaptive multi-country randomized, placebo-controlled, double-blinded trial of the safety and efficacy of treatments for patients with monkeypox virus disease.
It aims to facilitate the participation of clinical researchers, countries’ research institutions or regional networks that wish to contribute to the generation of missing data and reduce uncertainties regarding monkeypox treatments.
Any research institution interested in joining this international trial can contact the trial secretariat at the following address: email@example.com
For further information, please find below the relevant documents: