Characterization of interventional clinical trials for monkeypox; systematic review of ClinicalTrials.gov database

Abstract

Background: Monkeypox (mpox), a zoonotic viral infection, poses a global threat that is being acknowledged at the national and international levels. This systematic review aims to identify and characterize interventional clinical trials for mpox.

Method: All interventional clinical trials registered at ClinicalTrials.gov for mpox were searched up to January 6, 2023. We described the characteristics of interventional clinical trials, and drug interventions (including drugs and vaccines).

Results: As of January 6, 2023, there were 10 clinical trials in the ClinicalTrials.gov registry that met our criteria. Most of the interventional clinical trials were focused on the treatment (N = 4, 40%) and prevention (N = 4, 40%) of mpox. From the 10 trials, 50% used random treatment allocation, and six (60%) chose the parallel assignment intervention model. All 10 studies were blinded, and six were open-label blinded. The largest proportion of the clinical trials (N = 4, 40%) were registered in Europe, followed by America (N = 3, 30%) and Africa and others (N = 3, 30%). The JYNNEOS vaccine (40%), followed by Tecovirimat (30%) were the most frequently studied drugs used against mpox.

Conclusion: A limited number of clinical trials have been registered on ClinicalTrials.gov since the first case of mpox was reported. Therefore, there is an urgent need to conduct large-scale randomized clinical trials to assess the safety and efficacy of the drugs and vaccines being used against the mpox virus.

Keywords: clinical trials; immunity; monkeypox; vaccination; viral.