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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 Organization study found no mortality benefit, the Financial Times reported on Thursday, 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 randomized 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.
Read more: 2 drugmakers just hit setbacks in the coronavirus vaccine race, while 2 others forge ahead. Here’s everything we know about the timeline for a COVID-19 vaccine and when you might be able to get a shot.
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 …read more
Source:: Business Insider – Science