New COVID drugs are delayed and tests are difficult


Paxlovid antiviral pill COVID-19 dramatically reduces the risk of hospitalization and death.Credit: Getty via Chris Sweda / Chicago Tribune / Tribune News Service

After two years of continuous research, scientists have compiled a collection of therapies to treat people with COVID-19. But now researchers fear that developing new treatments could miss the clinical trials needed to test them.

In many places, vaccinations have reduced the number of potential study participants and led to a reduction in serious illness. Reluctance to participate in the competition is growing, and the availability of intensive treatment complicates statistical analysis.

“It used to be easy to do research. Now you need to develop a study that meets medical standards that doctors want to do and patients want to do. And it’s very difficult, ”said Elizabeth Hochmann, an infectious disease expert at Massachusetts General Hospital in Boston.

Physicians treating people with COVID-19 can choose from half a dozen therapies recommended by national authorities, such as the World Health Organization or the U.S. Food and Drug Administration. These include steroids, synthetic antibodies, and antiviral pills. Some reduce the risk of death in hospitals. Others are less likely to be hospitalized. In some countries, mortality rates are falling, and people have access to this treatment and modeling1 Widespread antiviral treatment COVID-19 can prevent most of the predicted deaths.

Antiviral tools: Date of first recommendation by the World Health Organization for eight treatments for COVID-19.

Source: World Health Organization, US National Institutes of Health

However, in many areas, the availability of available therapies is limited and the cost is high. There is also a dangerous manifestation of resistance to drugs like Paxlovid, an antiviral developed by Pfizer in New York. Researchers fear that progress in the development of new treatments will come to a halt, even in many parts of the world.

A small pool

Vaccines have led to a sharp decline in mortality in some affected countries. In Brazil, for example, the death toll dropped from 3,000 a day to 200 a day. But this good news complicates the test.

When the pandemic began, Edward Mills, a health researcher at McMaster University in Hamilton, Canada, and his colleagues conducted tests in Brazil to see if current drugs could prevent the most serious form of COVID-19. When they began the so-called TOGETHER test in early 2020, the proportion of study participants who eventually died or had to be hospitalized was 16%. However, once vaccines became available, their numbers were reduced by 3-5%. Before continuing to test for the serious side effects of certain medications, organizers had to register more people who were at risk of serious illness. It means expanding the trial to South Africa, Pakistan, the Democratic Republic of the Congo and Rwanda.

Another type of infinity

Researchers also fear that those who meet the test requirements will be less willing to participate than they were at the beginning of the pandemic.

When Homann began overseeing a trial called ACTT to test COVID-19 treatment in early 2020, recruitment was quick: there was no better option for sick people. As of April 2020, 1,062 people had participated in the trial. By the end of 2020, remdesivir showed that antiviral drugs could accelerate healing and prevent death.two.

However, according to Hochmann, effective treatments such as remdesivir have emerged, and it has become increasingly difficult to recruit participants for follow-up trials. Many people today feel safer to follow a prescribed regimen that includes both remdesivir and the steroid dexamethasone than to use an experimental drug.

“It takes a lot of amazing people to step into a third drug,” Homann says. If your life is not in danger, you need a civil mindset to sign up for the trial, says Homann, who suspects that it has dampened the altruism of potential participants in the pandemic’s stress and unrest.

Other types of fluctuations may affect the clinical trial of treatment for severe COVID-19 in Canadian losartan. Most people in Canada were vaccinated in 2021, so most people who will take the losartan test have not been vaccinated. This may explain the increase in the share of people invited to participate in the study, but decreased: 18% by mid-2021 and 35% by the end of the year.3. The organizers of the tests suspect that factors that deter people from receiving vaccines, such as distrust of basic medicine, prevent them from using experimental drugs.

Statistical complexity

The number of treatments has increased, so the complexity of statistical calculations to determine the effectiveness of a new drug has also increased. As a result, researchers may have to engage more participants, which takes more time.

That’s exactly what the organizers of the PRINCIPLE test have to say, whether reusable drugs can speed recovery or not, and whether infected UK residents can be discharged from hospital. All participants in the study will receive the current standard of medical care, which means that doctors will be able to prescribe treatment in addition to the medication being tested. Lee Mi-yu, a medical statistician at Oxford University and chief statistician at PRINCIPLE, says. Small differences mean that researchers have to work with large groups of participants, so the trials take longer.

Hochman noted that if researchers want to compare the new, highly effective drug with Paxlovid, a potent antiviral drug, they are the mainstay of treatment for the new COVID-19, which will require many contestants to determine a statistically significant difference between recruits. two treatments. “To accept Paxlovid, you have to have a real game changer,” he says.

However, researchers may have to accept the difficulty of finding a Paxlovid competitor. Recent cell experiments 4,5 suggests that Paxlovid-resistant strains of the virus may occur – a reminder that no matter how complex the playing field, the virus determines the rules of the game.

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