AUTHOR=Alorfi Nasser M. , Alshehri Fahad S. , Haseeb Abdul 

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

JOURNAL=Frontiers in Public Health

VOLUME=11

YEAR=2023

URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1144325

DOI=10.3389/fpubh.2023.1144325

ISSN=2296-2565

ABSTRACT=<sec><title>Background</title><p>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.</p></sec><sec><title>Method</title><p>All interventional clinical trials registered at <ext-link ext-link-type="uri" xlink:href="https://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link> for mpox were searched up to January 6, 2023. We described the characteristics of interventional clinical trials, and drug interventions (including drugs and vaccines).</p></sec><sec><title>Results</title><p>As of January 6, 2023, there were 10 clinical trials in the <ext-link ext-link-type="uri" xlink:href="https://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link> registry that met our criteria. Most of the interventional clinical trials were focused on the treatment (<italic>N</italic> = 4, 40%) and prevention (<italic>N</italic> = 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 (<italic>N</italic> = 4, 40%) were registered in Europe, followed by America (<italic>N</italic> = 3, 30%) and Africa and others (<italic>N</italic> = 3, 30%). The JYNNEOS vaccine (40%), followed by Tecovirimat (30%) were the most frequently studied drugs used against mpox.</p></sec><sec><title>Conclusion</title><p>A limited number of clinical trials have been registered on <ext-link ext-link-type="uri" xlink:href="https://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link> 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.</p></sec>