A large federal study that found an antiviral drug, remdesivir, may record recovery in hospitals in Covid-19 patients, has begun a new phase of research.
Now it will investigate whether adding another medication, beta-interferon – which kills viruses in particular but can also tackle inflammation – would improve the effects of inhibitor and make recovery even faster.
To date, remdesivir, an experimental drug, has been approved for emergency use by the Food and Drug Administration to treat Covid patients. In a large clinical trial, sponsored by the National Institutes of Health, remdesivir was shown that the recovery time was modestly short, averaging four days, but it did not reduce death.
The additional drug, beta-interferon, is already approved for the treatment of multiple sclerosis, which benefits from its anti-inflammatory effect.
The American trial, known as ACCT, is designed to move fast. Known as an adaptive trial, it is a race between treatments. It tests one treatment against another and when the results are in, the medicine that won this phase becomes the control drug for the next phase, in which it is tested against another drug.
The new phase is the third of the study. A total of 1,000 patients will receive inhibitor and placebo as inhibitors and beta-interferon.
Interferon is given as an injection. Remdesivir, made by Gilead Sciences, is given as an intravenous infusion.
A team of researchers held multiple group conferences to try to select the new test medication for Phase 3, said Dr. Peter Chin-Hong, an expert scholar at the University of California, San Francisco.
Their first suggestion was to try an experimental drug made by Merck known as EIDD-2801, which, like brake drug, is an antiviral but a pill. But they wanted something that was already approved and available for other diseases. They hope that by showing that the new medicine was effective, and already approved for other diseases, that doctors could give it to Covid patients immediately.
The group also considered dexamethasone, a common steroid that appears to be effective in reducing the risk of death in critically ill patients. The drug, which suppresses inflammation, may be even better when added to brake drug, the researchers reasoned.
But they worried. Dexamethasone is cheap and easily available. With widespread publicity about the apparent efficacy, many patients would participate in a study in which they could receive a placebo.
Then the group waited with beta-interferon, which went several things ahead. It is marketed as a treatment for multiple sclerosis, due to its weak anti-inflammatory properties. It kills the new coronavirus in laboratory studies and it kills SARS and MERS, which are also coronaviruses.
And, most impressively, said Dr Chin-Hong, the drug was tested twice in Covid patients, with promising results. One test was in England, where beta-interferon was delivered as a placebo to 101 patients in the hospital. They inhaled it into a nebulizer, a device similar to that used to deliver asthma medication.
The study, although small, found that those who received the drug performed better than those who received a placebo.
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Frequently Asked Questions
Updated August 17, 2020
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Why does standing six feet apart help others?
- The coronavirus spreads primarily by drips from your mouth and nose, especially when you cough or sneeze. The CDC, one of the organizations using that measure, bases its six-foot recommendation on the idea that most large drops that expel people when they cough or sneeze fall within six feet to the ground. But six feet has never been a magic number that guarantees complete protection. Noses, for example, can launch drops much farther than six feet, according to a recent study. It’s a rule of thumb: you need to be the safest to stand six feet apart, especially when the wind is blowing. But always wear a mask, even if you think you are far enough apart.
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I have antibodies. Am I immune now?
- At the moment, that probably seems like at least several months. There have been horrific accounts of people suffering from what appears to be a second bolt of Covid-19. But experts say these patients may have a prolonged course of infection, with the virus taking a slow toll weeks to months after initial exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies may only last two to three months in the body, which may seem worrying, but that is perfectly normal after an acute infection progresses, said Dr. Michael Mina, an immunologist at Harvard University. It could possibly get the coronavirus back up, but it is highly unlikely that it would be possible in a short window of time from initial infection or the second time safe.
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I am a small business owner. Can I get relief?
- The incentive bills introduced in March provide assistance to the millions of American small businesses. Those eligible for support are non-profit companies and organizations with less than 500 workers, including sole proprietorships, independent contractors and freelancers. Some larger companies in some sectors are also eligible. The assistance provided, which is managed by the Small Business Administration, includes the Paycheck Protection Program and the Economic Damage Disaster Program. But many people have not seen payments yet. Even those who have received help are confused: the rules are draconian, and some are stuck on money they do not know how to use. Many small business owners get less than they expected or heard nothing at all.
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What are my rights if I am worried about returning to work?
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What will school look like in September?
- It is unlikely that many schools will return to a regular schedule this fall, requiring the grinding of online learning, easy childcare and stunted workdays to continue. The two largest public school districts of California – Los Angeles and San Diego – said on July 13 that instruction will be remote only in the fall, citing concerns that growing coronavirus infections in their areas pose too great a risk to students and teachers. Together, the two districts enroll about 825,000 students. They are the largest in the country to date to abandon plans for even a partial physical return to classes when they reopen in August. For other districts, the solution will not be an all-or-nothing approach. Many systems, including the nation’s largest, New York City, are creating hybrid plans that include some days attending classrooms and other days online. There is no national policy yet, so check regularly with your municipal school system to see what is happening in your municipality.
The other study, in Hong Kong, involved 127 patients receiving beta-interferon along with two antiviral drugs. The patients were hospitalized, but many were not seriously ill. The drug cocktail was superior to placebo in accelerating recovery.
But the US trial will be the only major rigorous trial to test beta interferon in Covid patients.
The first phase of inhibitory involvement began on February 21, testing the experimental drug against a placebo. That phase closed on April 19 after 1,000 patients were enrolled. The National Institute for Allergy and Infectious Diseases, which sponsors the study, announced preliminary results on April 27.
The next phase began on May 8, testing for brakes and a placebo against brakes and baricitinib, an arthritis medicine that causes inflammation. Researchers hope that the addition of the arthritis medication would improve patients’ outcomes by triggering an overreaction of the immune system to the virus, a so-called cytokine storm, which can occur in seriously ill patients and can be fatal. After 1,000 patients were enrolled and followed up, that part of the study was closed.
Phase 2 results are still being evaluated. Dr Chin-Hong said he and others were fairly certain that if the addition of the arthritis drug, baricitinib, had been helped in any case, the effect would not have been enormous. If the drug had shown an impressive effect, the study’s data safety and monitoring table, which oversees the trial, would have stopped it and given each patient inhibitor and baricitinib. That combination would then have been the control drugs for Phase 3 of the study.
That did not happen.
Rather than wait while the data with baricitinib could be fully evaluated, the study moved on to its next phase, testing inhibitors and placebo against inhibitors and beta-interferon.
Registration began this month.
At the University of California, San Francisco and San Francisco General, nine patients have participated so far.
“We are approaching another today,” said Drs. Chin-Hong on Monday.
