Scientists Behind COVID-19 RECOVERY Trial Turn Attention to Monkeypox
The Oxford University team behind the global RECOVERY study on COVID-19 treatments is now focusing its attention on developing a new monkeypox treatment.
The scientists are evaluating tecovirimat, developed by SIGA Technologies. Tecovirimat is designed to prevent the monkeypox virus from leaving infected cells, thus stopping its spread. It was originally made for smallpox. The Medicines and Health Products Regulatory Agency (MHRA) licensed the drug early this year for monkeypox based on positive outcomes from initial trials on healthy human volunteers and animals.
The trial has already started recruiting participants, with the goal to enroll at least 500. Currently, tecovirimat is used to treat severe complications of monkeypox in hospitalized patients. However, there have not been any clinical studies that assess whether it can help in monkeypox recovery.
The PLATINUM trial will test tecovirimat's safety and recovery. It is led by Peter Horby, a professor of emerging infections and global health and director of the new Pandemic Sciences Institute, and Sir Martin Landray, a professor of medicine and epidemiology. Horby and Landray were also the joint chief investigators of the Randomized Evaluation of COVID-19 (RECOVERY) study.
The PLATINUM trial has the backing of the University of Liverpool, the U.K. Health Secretary Agency, Chelsea and Westminster Hospital and NHS Foundation Trust. The entire program will receive an award of approximately $4.4 million from the National Institute for Health and Care Research (NIHR).
"Led by the same experts behind the world-leading COVID-19 RECOVERY trial – which developed ground-breaking treatments for patients – this new monkeypox treatment trial will test the effectiveness of the antiviral tecovirimat in fighting the disease," Maggie Throup, the minister for public health, said in a statement.
Participants will be randomized to complete a 14-day course of either 600 mg tecovirimat twice a day or a matched placebo regimen. Unlike the RECOVERY study for COVID-19, which enlisted hospitalized patients, the PLATINUM study will be community-based, with enrollees taking the treatment or placebo in their own homes.
Over the 14 days, the scientists will evaluate the rate at which mucosal and skin lesions heal. Other elements to be studied include the time it takes until throat and lesion swabs test negative for monkeypox and the number of patients who need to be hospitalized due to disease complications.
The study comes at an opportune time in the fight against monkeypox, particularly as some scientists are questioning whether the current vaccines being used for it are truly effective.
"Monkeypox is a distressing and sometimes dangerous infection. For the benefit of current and future patients worldwide who have been diagnosed with monkeypox, we need definitive evidence that tecovirimat is safe and effective," Horby said. "Although the early data on tecovirimat are promising, only a randomised clinical trial will provide the level of evidence we need to treat patients with confidence. PLATINUM will provide that evidence."
SIGA is providing both tecovirimat and the placebo drug for this trial.
As of this writing, monkeypox has now been detected in all 50 U.S. states, according to ABC News. Additionally, the California Department of Public Health announced that it will no longer be calling monkeypox by its name, but as "MPX" or "mpox" to reduce the stigma that comes with the disease.