ISARIC Observational Cohort Study / Low-Intervention Clinical Trial

ISARIC and partners are executing a multi-centre, multi-country study to document the effects of disease and treatment in patients with monkeypox. The study is derived from an Expanded Use Protocol currently underway in the Central African Republic and is being implemented across Europe. Please return to this site for updated information and study documents.

ISARIC-WHO Clinical Characterisation Protocol and Case Report Form

The Clinical Characterisation Protocol (CCP) is designed to accelerate a research response to any severe or potentially severe acute infection of public health interest. The protocol and case report form enable data and biological samples to be collected rapidly, in a globally-harmonised manner. All institutions planning to collect detailed clinical data and/or samples to characterise monkeypox cases are invited to adapt and/or implement these resources at their sites.

This form is designed to supplement the WHO Monkeypox minimum dataset case reporting form with detailed clinical data.

Expanded access protocol for the use of tecovirimat for the treatment of monkeypox infection in Central African Republic

In partnership with the Ministry of Health of the Central African Republic and Institut Pasteur de Bangui, we are conducting an Expanded Access Programme in which patients with laboratory-confirmed monkeypox are being offered treatment with tecovirimat – an antiviral manufactured and provided by SIGA Technologies Inc. The aim of the study is to describe the outcomes of patients treated with tecovirimat. This is the first protocolised use of tecovirimat in a monkeypox-endemic country.