Tpoxx: Oxford scientists behind Covid breakthrough launch first monkeypox treatment study
The UK scientists behind the breakthrough Covid Recovery trial have turned their attention to the latest global health emergency - monkeypox.
The University of Oxford academics have become the first researchers in the world to launch a clinical trial to assess a treatment for the virus in humans.
They are hoping to find out whether the drug can help to alleviate symptoms among those infected.
The researchers plan to recruit 500 people from around the UK to join the trial to test whether the antiviral Tecovirimat – also known as Tpoxx – can help reduce the amount of time people are sick for.
The drug was created to treat smallpox, and works by preventing the virus from leaving the infected cell, which stops the spread within the body.
Health officials in the UK licensed the drug earlier this year based on results from initial studies in animals and safety evidence from human volunteers.
It is currently offered to patients with severe complications who are being treated in hospital.
Until now, there had been no clinical trials to confirm whether Tpoxx can help monkeypox patients recover from the disease.
So, researchers who were behind the Recovery trial during the Covid pandemic launched the trial to test the drug in humans.
The Platinum trial will be the first randomised controlled trial of a treatment for monkeypox in humans in the world.
This means that half of the participants – who will have a confirmed diagnosis of monkeypox but not be sick enough to need hospital care – will be given Tpoxx, while the other half will be given a placebo, or dummy drug.
Most patients with monkeypox will be eligible to enrol in the trial, which will involve them taking the medication, or the placebo, twice a day for 14 days.
They will be followed up for a month to assess whether taking the drug reduces symptoms – including the length of time people have painful skin lesions – or whether it could reduce the amount of time people need to stay in isolation.
Researchers will also examine whether the drug can reduce the amount of time people test positive for the virus.
While vaccines developed for smallpox may reduce the risk of catching monkeypox, there are currently no proven treatments to speed recovery in those who develop the disease.
The study, commissioned and funded by the National Institute for Health and Care Research (NIHR), recruited its first participant on Friday.
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Sir Peter Horby, professor of emerging infections and global health at the University of Oxford, said: “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.
He said the early data was "promising," but added that "only a randomised clinical trial will provide the level of evidence we need to treat patients with confidence."
Professor Lucy Chappell, chief executive of the NIHR and chief scientific adviser at the Department of Health and Social Care, said the Platinum study was "a very important next step towards looking at treatments for monkeypox for those being outside of hospital."
“It’s crucial that we invest in developing, refining and evaluating treatments for this disease," she added.
On Monday, the UK Health Security Agency launched a pilot offering eligible patients smaller doses of monkeypox vaccine, amid global shortages of the jab.
Since the start of the outbreak there have been more than 3,000 UK cases, with most of these identified in England.
What are the symptoms of monkeypox?
It usually takes between five and 21 days for the first symptoms of the infection to appear.
The first symptoms of monkeypox include:
a high temperature
a headache
muscle aches
backache
swollen glands
shivering (chills)
exhaustion
A rash, which often begins on the face before spreading, usually appears one to five days after the first symptoms.
The rash, sometimes confused with chickenpox, starts as raised spots before becoming small fluid-filled blisters. The blisters eventually form scabs and later fall off.
Symptoms usually clear up in two to four weeks.