2023-05-18 02:23:59
The Federal Commission for the Protection against Sanitary Risks (Cofepris)reported through a statement that it has authorized a clinical trial randomized placebo-controlled trial to test the safety and efficacy of tecovirimat medicinean antiviral used as treatment of mpox or monkeypox virus in humans.
In accordance with information from Cofepris, compliance with national regulations was verified, as well as international conventions on human research to carry out a safety and efficacy trial of the tecovirimat medicine as part of monkeypox treatment.
What is monkeypox?
The monkey pox is a infectious disease caused by a rare virus, a species of the genus Orthopoxvirus, which is more common to affect rodents, such as rats, mice, non-human primates, such as monkeys. However, it is also transmittable by physical contact in infected people, reveals the World Health Organization (WHO).
Cofepris authorizes clinical trial of a drug against monkeypox/ Photo: iStock
What are the symptoms of monkeypox?
Los monkeypox symptoms most common are skin rashes or mucosal lesionsthese can last from two to four weeks and are usually accompanied by fever, chills, headache, muscle aches, back pain, swollen lymph nodes, and lack of energy.
In Mexico, until last April there were 14 deaths due to monkeypox (13 men and 1 woman), which were identified with lesions compatible with the monkey poxSubsequently, they underwent a laboratory study that confirmed the results.
In the absence of a specific medication to treat the monkeypox symptoms, health specialists began to treat her with antiviral drugs, usually recommended for smallpox, such as tecovirimat (TPOXX) or brincidofovir (Tembexa).
Cofepris authorizes clinical trial of a drug against monkeypox/ Photo: iStock
What is tecovirimat?
The tecovirimat it’s a antiviral medicine approved by the Food and Drug Administratrion (FDA) to treat smallpox in both adults and children. Currently, it is considered a drug under clinical investigation against monkeypoxsince it is not yet approved by the FDA to specifically treat this disease.
Not having the backing of the DFA, this clinical trial will seek to determine if the tecovirimat medicine is able to help treat people infected with monkeypox.
The cofepris reported that the protocol was authorized on April 29, 2023, the research group will define the start of the recruitment process of the participants during the clinical trialwhich will be 14 days, extending the follow-up for two months.
Cofepris authorizes clinical trial of a drug against monkeypox/ Photo: iStock
In addition, he informed that to request access to the research protocol, interested persons may contact the number 55-27-30-88-36 of the Department of Infectious Diseases of the National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) of the Health Secretary.
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If you are interested in knowing more about the monkeypox, Stay and watch the next video.
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