Sat. Oct 16th, 2021

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Dr. Dennis Hadjiyiannakis, medical director for the Lancashire Clinical Research Facility (LCRF), says early data from the United States suggests that science is “onto a winner” with the tablet molnupiravir.

Interim results of a study into the medication – which was originally developed to treat influenza – last week indicated that it halved the risk of hospitalisation or death as a result of Covid.

In a trial whose findings are yet to be peer-reviewed, 7.3 percent of Covid-positive patients given molnupiravir ended up needing hospital treatment, compared to 14.1 percent of those given a dummy drug or placebo.

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Dr. Dennis Hadjiyiannakis at the Royal Preston Hospital

None of those who took the molnupiravir tablet died – whereas eight people in the placebo group later lost their lives to the virus.

Now the UK is conducting its own trial into what could become the first oral antiviral treatment for Covid – and the Royal Preston Hospital is set to play a major part in the process.

It is looking to recruit at least 20 volunteers who would help establish the effectiveness of the drug, which needs to be administered in the early stages of the disease in order to work.

Dr. Hadjiyiannakis said that the tablet had the potential to become a “second line of defence” against Covid in addition to vaccines – and held out the tantalising hope of exactly what that might mean in practice.

Helena Prady, senior research nurse and Rosalind Szurko, research nurse

“I think this will allow us to return to normal life. If you think of flu, we don’t stop life because there is a flu outbreak.

“People have a flu vaccine and they [can take the drug] Tamiflu if it’s warranted – and it will be the same with [Covid]. There will still be some sick patients, but the hope is that [the drug] will reduce [sickness] significantly and make this an illness we can all live with.

“It also looks like it will work against all the mutations – so as the virus changes, it won’t stop this [drug] from working.

“Everybody will [still] get vaccinated as per the government protocol, but this is a second line of defence if people haven’t been vaccinated or [for those people for whom Covid] breaks through despite the vaccine,” explains Dr. Hadjiyiannakis, who is also a consultant oncologist at the trust that runs the Royal Preston and Chorley and South Ribble Hospital.

To take part in the trial, people need to be enrolled within five days of developing mild to moderate symptoms and subsequently testing positive for Covid.

They must be over 18, not on any other drug trial and, apart from having Covid, otherwise be in good health without any underlying conditions.

Pregnant women are not eligible to volunteer for the trial and both women and men who do sign up must agree to use contraception for up to three months after taking the medication.

“It is important that a woman doesn’t get pregnant and that a man taking the drug doesn’t get a woman pregnant,” says Helena Prady, senior research nurse at the LCRF.

Other than that, however, she hopes that people will find taking part in the trial straightforward.

“They come in on day one and on that visit they would give their consent. We then take their blood pressure and [do some] blood tests, an ECG and temperature check to [ensure] that it’s appropriate to put them in the trial.

“They take the first doses of the drug here [in the hospital] and stay for an hour afterwards and then we give them the rest of the tablets to take at home – four capsules twice a day, fasting for two hours before and an hour after.”

Volunteers have to return for outpatient appointments on seven occasions over the following four weeks. Although they will receive special permission to leave self-isolation during the period that they are infectious, they must travel to and from the hospital in private transport, without stopping en route to or from their initial appointments. Infection prevention and control measures will be in place during their consultations.

Helena believes that the majority of volunteers will probably come from people who are currently well, but fall ill with Covid in the coming weeks – and remember having heard about the trial.

The LCRF is one of seven centres across the country attempting to recruit a total of 180 volunteers for the trial, which is part of the AGILE coronavirus drug testing initiative – a collaboration between the University of Liverpool, Southampton Clinical Trials Unit and other partners including Lancaster University.

Merck, the manufacturer of molnupiravir, is poised to seek authorisation for emergency use of the drug in the United States based on the encouraging initial results of its own study.

Dr. Hadjiyiannakis said that the main side effect of the drug according to the data so far available is “mild sickness”, which can be easily controlled with anti-sickness tablets.

He added: “If I picked up coronavirus tomorrow, I would enter this trial. I think the benefit [will] potentially be very great and would allow us to enter normal life.”

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