- Several leading coronavirus clinical trials are focusing on testing experimental combinations of medicine to treat COVID-19.
- These studies are building on top of the early success of remdesivir, an antiviral drug developed by Gilead Sciences that helped hospitalized COVID-19 patients recover modestly faster.
- On Friday, the US National Institutes of Health launched a massive study that will test three drugs seeking to tamp down a runaway immune response in COVID-19 patients. These drugs will be tested in addition to giving remdesivir to the trial participants.
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The US National Institutes of Health is launching its latest round of clinical trials, announcing plans on Friday to test three immune-modulating drugs in combination with the antiviral treatment remdesivir.
On April 29, an NIH trial found remdesivir helped hospitalized COVID-19 patients recover modestly faster. The typical patient given remdesivir showed improvement in 10 days, five days sooner than the typical patient given a placebo IV infusion.
On its own, remdesivir is not a transformative treatment for COVID-19. A World Health Organisation study found it didn’t prevent people with the novel coronavirus from dying, which aligns with the weak benefit found in the NIH study.
But ever since those remdesivir results were first announced, researchers have eyed combinations of treatments to ultimately be a medical breakthrough. That would mimic the playbook used to treat HIV, where three-drug cocktails led to dramatic improvements in patients.
“We know clearly, as instructed by the global experience in HIV, that combination therapies often have advantages compared to single-drug therapy,” Dr. Andrew Badley, director of the Mayo Clinic’s HIV Immunology Laboratory, said in an April 30 interview with Business Insider.
In the latest NIH trial, said Friday, researchers will recruit 2,100 hospitalized patients to test three immune-modulating drugs in combination with remdesivir.
The three treatments being tested are Johnson & Johnson’s anti-inflammatory drug Remicade, Bristol Myers Squibb’s arthritis treatment Orencia, and AbbVie’s experimental treatment called cenicriviroc. Patients will be randomised to receive either one of those three drugs or a placebo.
“These are the therapeutic we are betting on most strongly,” said NIH Director Dr. Francis Collins on a Thursday call with reporters.
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All participants will also receive remdesivir. Physicians can also give convalescent plasma or dexamethasone to trial participants, based on their own discretion.
Shutting down an overactive immune system
This latest study is specifically geared to fight the cytokine storm associated with severe COVID-19 cases. Collins likened the virus to a small kitchen fire and the immune system to a sprinkler system. The goal is for the sprinklers to extinguish the flames.
But when the sprinklers don’t shut off, the water damage can be even more extensive. For critically ill COVID-19 patients, the worst of the disease is often caused by the body’s own overactive immune response instead of the actual virus.
“These three drugs are aiming to try to get the balance just right for those people where the sprinklers seem to be going much too strong and they’re in the ICU with serious lung issues,” he added. “You want to try to rescue them from what otherwise could be a really terrible outcome.”
We could know in a few months if one of these combinations works
The trial will likely need until next spring to fully complete, with the study requiring about six to eight months to enroll all the volunteers, monitor them, and analyse the data, said Dr. Christopher Austin, an NIH centre director who helped design the research.
But an independent board of experts will be able to take early looks at the data when the trial recruits 25%, 50% and 75% of the total trial population.
If one of the drugs is overwhelmingly effective, that could be known in a couple of months, Austin estimated.
The NIH’s infectious disease unit previously tested a combination of remdesivir and Olumiant, an arthritis drug marketed by Eli Lilly. Results announced in September showed a slight but statistically meaningful benefit in adding Olumiant: a one-day reduction in median recovery time. The Indianapolis-based drugmaker is in talks with the US Food and Drug Administration about potential emergency approval for Olumiant as a COVID-19 treatment.
The NIH considered more than 130 immune modulators and selected these three based on “several factors including their relevance to COVID-19, strong evidence for use against inflammatory reaction and cytokine storm and availability for large-scale clinical studies.”
The NIH has a number of COVID-19 drug trials underway
The NIH has launched a wide range of studies to test potential COVID-19 treatments. Ongoing NIH-ran coronavirus trials include:
- Testing a monoclonal antibody developed by Eli Lilly in two studies, respectively in hospitalized and non-hospitalized patients. The hospitalized trial was recently paused by a board of independent experts overseeing the research. Collins said that board will meet on October 26 to determine if enrollment should resume.
- A trio of studies testing blood thinners in COVID-19 patients, hoping to prevent blood clots. These studies are testing Bristol Myers Squibb’s Eliquis and aspirin in non-hospitalized patients, as well as heparin in hospitalized patients.
- Two mid-stage studies for hospitalized patients, respectively testing AbbVie’s psoriasis drug Skyrizi and Humanigen’s experimental antibody treatment lenzilumab. Both these drugs are given in conjunction with remdesivir and will be tested against a group of patients only getting remdesivir.
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