UK researchers behind RECOVERY return for monkeypox drug study, launched ahead of NIH trial – Endpoints News
The UK-based University of Oxford researchers behind the success of the Covid-19 RECOVERY treatment trial are back, this time concocting a randomized controlled trial to see if the smallpox treatment from Siga Technologies Tpoxx (tecovirimat) is safe and effective for monkeypox.
The first participant enrolled in the PLATINUM trial (a randomized, placebo-controlled trial of tecovirimat in non-hospitalized monkeypox patients) on Friday, building on successes in animal models that led to approvals from the FDA and the UK, and follows the NIH’s National Institute of Allergy and Infectious Diseases announcement that it is launching a similar trial in the US next week.
The FDA approved tecovirimat in 2018 for the treatment of smallpox in adults and children, and the CDC used an expanded access program to distribute limited quantities (less than 300 pills to date) from its stockpile of over a million doses. And although the antiviral is only approved as a treatment for smallpox, its FDA approval was based on studies in nonhuman primates infected with monkeypox.
Siga CEO Phil Gomez said Terminal news in an interview last week that his company has received $60 million in international orders for tecovirimat and is supplying products for 10 RCTs around the world through government public health agencies.
“The good news is that these protocols have been widely shared in the US, Canada, UK and EU,” he said. “So we hope that wherever the epidemic goes, we will have the opportunity to quickly collect data and archive it in the United States and Canada.”
Sir Peter Horby, the UK-based trial’s principal investigator, said tuesday that the trial is necessary because “its efficacy and safety in patients with monkeypox have never been demonstrated”. He called the trial they use the “gold standard” for understanding if the treatment works.
The remote trial seeks to enroll about 500 participants and is open to anyone with monkeypox who has active skin or mucosal lesions, Horby said. The trial will test tecovirimat 600mg twice daily for 14 days versus placebo (randomized 1:1) on the self-reported cure rate of monkeypox and time to viral clearance assessed by weekly swabs.
Confirmed participants who have consented will receive a pack with the drug, and they will complete a questionnaire every day for 4 weeks regarding their symptoms, and take swabs from their throat and skin lesions once a week for 4 weeks, and those will be picked up by courier.
The NIAID trial of tecovirimat in the United States will be conducted in collaboration with the AIDS Clinical Trials Group.
“People infected with monkeypox, including people living with HIV, would be eligible and encouraged to register. More than 500 volunteer participants will be randomly assigned to receive either tecovirimat or a placebo in a two-to-one ratio,” NIAID said. “The investigators will assess whether those taking tecovirimat recover faster than those taking a placebo, among other data points.”
Part of the US study will be open to pregnant and breastfeeding women, as well as children, and will be closely monitored for safety. NIAID is also starting another trial of tecovirimat in adults and children with monkeypox in the Democratic Republic of the Congo, but this was in the works before the current outbreak of monkeypox in several countries.