A randomized, placebo-controlled trial to investigate the safety and efficacy of the antiviral drug tecovirimat in patients with monkeypox has commenced in the Democratic Republic of the Congo (DRC), according to a press release from the National Institutes of Health (NIH). The efficacy would test if the drug could provide symptomatic relief and also prevent serious outcomes including death.

The double-blinded trial (NCT05559099) led by the National Institute of Allergy and Infectious Diseases (NIAID) and DRC’s National Institute for Biomedical Research (INRB) in collaboration with CDC, WHO, the aid organization Alliance for International Medical Action (ALIMA) and the Institute of Tropical Medicine Antwerp.

A total of 450 patients with monkeypox will constitute the study group, both adults and children including pregnant women. The participants would be randomly assigned (1:1)  to receive either oral tecovirimat or placebo capsules twice daily for 14 days along with standard care as inpatients. The average time taken for the skin lesions to heal would be compared between the two groups. The secondary endpoints include severity and duration of the disease, negative test for the monkeypox virus and mortality.

All participants would be hospitalized for at least 2 weeks for supportive care. Blood, throat swab and skin lesion swab samples will be regularly collected and tested in addition to clinical monitoring of the volunteers. Once the lesions are dried and scabs are formed and the participants test negative for the virus for two consecutive days, they would be discharged. The follow-up period is a minimum of 28 days. An optional follow-up visit has been scheduled after 58 days for clinical and lab evaluation. The study is expected to be completed by September 2024.

Source: NIH Press Release, October 12, 2022.