In the United States, a Phase 3 clinical trial testing the monkeypox antiviral tecovirimat is recruiting adults and kids with the monkeypox infection. The evaluation of the monkeypox vaccine will consist of a study testing the vaccine on more than 500 patients.
The National Institute of Allergy and Infectious Diseases (NIAID) is financing the clinical trial for the antiviral. The project, which is being led by the NIAID-funded AIDS Clinical Trials Group (ACTG), could include other locations as well.
The SIGA Technologies manufactured drug, tecovirimat, has been given approval by the U.S. FDA for the treatment of smallpox.
The antiviral medication works by preventing the viral particles from leaving the infected human cells, and thus prevents the spread of the virus around the body. The target for the drug is a protein present in the virus for smallpox, as well as the monkeypox virus. For U.S. patients with monkeypox, tecovirimat is now available to clinicians via enhanced access or the “need-based use”.
After an outbreak of the monkeypox virus was reported at the start of this year, both the World Health Organization (WHO) and the U.S. declared the monkey virus a public health emergency
According to the Department of Health and Human Services, Men who engage in sex with other men have made up the majority of cases so far, although infection can also spread to women and young children. The WHO reported that across 102 countries, 52,996 cases and 18 fatalities between January and September of this year while in the U.S, the Centers for Disease Control and Prevention (CDC) in the United States has information on over 20,000 patients.
Dr. Anthony S. Fauci, Director of NIAID stated, “The infection caused by monkeypox can be exceedingly severe and last for weeks. Some questions that were very crucial raised by this clinical experiment were that we lack effective data that would enable us to comprehend how well this medication may lessen uncomfortable symptoms of monkeypox and avoid significant consequences”.
Cases and outbreaks of monkeypox were largely limited to countries in central and west Africa previously, where the virus has been reported for some time.
Monkeypox symptoms might be mild and include flu-like symptoms and rough skin lesions. While more severe symptoms can include sepsis, dehydration, pneumonia, and brain inflammation among others.
The clinical trial for tecovirimat is being carried out in the U.S. and is being overseen a professor of medicine at Weill Cornell Medicine in New York City. The trial will be open to adults and children and to those with severe monkeypox virus infection or those at an elevaed risk for catching the virus.
Over 500 adult participants will be randomized to receive either tecovirimat or placebo pills.
The dose of tecovirimat capsules is determined by the participant’s weight and is administered orally for 14 days. Researchers will determine the effects to see which medication shows better efficacy. Clarity regarding the safest dosage and use of tecovirimat in children and pregnant women will also be provided by this study.
Participants will be kept under close observation for a period of 8 weeks. During that time daily skin checks will be conducted at home, in-person and virtual appointments followed by blood samples to physically examine the patient.