CORE PROTOCOL - An international adaptive multi-country randomized,placebo-controlled, double-blinded trial of the safety and efficacy of treatments for patients with monkeypox virus disease

24 July 2022

| Technical document

CORE PROTOCOL - An international adaptive multi-country randomized,placebo-controlled, double-blinded trial of the safety and efficacy of treatments for patients with monkeypox virus disease

Overview

This is a CORE protocol for an adaptive multiregional international global randomized, placebo-controlled trial to evaluate the safety and efficacy of drugs for the treatment of human monkeypox (Phase 3).

This protocol is the outcome of the deliberations from several individual experts and from various expert groups including: the WHO R&D Blueprint expert group on clinical trials and statistical methods experts, WHO Clinical Expert Group which comprised the monkeypox guidelines development group, regulatory experts consulted by the WHO Access to Medicines and Health Products Division, members of the WHO expert group for the Target Product Profile for monkeypox therapeutics.

This protocol also benefits from the inputs from over 500 experts who attended the first and second consultations on this topic in June and July 2022 organized by the National Institute for Biological Research (INRB) from the DRC, the ANRS Emerging Infectious Disease, and US NIAID/NIH with the support of WHO.

Useful links:

WHO Team

R&D Blue Print (RDB)