En español | For all the difficult news about the coronavirus in the last nine months — the global death toll of more than 1 million people, failed drug trials, survivors’ lingering symptoms — new drug and other therapies for COVID-19 are starting to emerge. Even as the world waits for a vaccine, researchers are confident they are making progress on treatments that can increase survival rates.
"We know so much more now than we did in March or April,” says Gopi Patel, M.D., associate professor of infectious diseases in the department of medicine at the Mount Sinai Hospital in New York City.
For one thing, she says, as hospital caseloads exploded early in the pandemic, patients with milder symptoms were asked to stay at home unless their condition worsened. When patients got sicker and returned to the hospital, they needed higher levels of care, sometimes requiring a ventilator. And once patients are on a ventilator, “the mortality rate is more than staggering,” Patel notes.
Now, more COVID-19 patients are sent to the hospital for treatment before they get seriously ill, saving lives and resources. In other cases, new therapies can help keep a subset of patients out of the hospital entirely. Here's what doctors say is making a difference now, and what may do so in the future.
Remdesivir and other antivirals
The antiviral remdesivir was approved by the U.S. Food and Drug Administration this week as the first treatment to fight COVID-19, after being shown in clinical trials to help hospitalized patients recover faster from the disease. The drug had previously been used — for months — under an emergency-use authorization. Doctors such as John Beigel, M.D., associate director for clinical research in the division of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases, called it “the one antiviral we know that works for SARS-CoV-2 [the coronavirus that causes COVID-19].”
Remdesivir (brand name Veklury), which is given by injection, is now approved for use only in a hospital or a health care setting “capable of providing acute care comparable to inpatient hospital care,” according to the FDA. In announcing their approval, FDA Commissioner Stephen M. Hahn, M.D., stressed that it was supported by safety data from multiple clinical trials and that it represented “an important scientific milestone in the COVID-19 pandemic.” Clinical trials assessing the safety and efficacy of the drug for smaller children are still ongoing, and the drug so far is approved only for those over 12.
A small study published in the New England Journal of Medicine in June showed that when the drug was administered over a 10-day period, 68 percent of hospitalized patients in the study showed clinical improvement. Research also shows that remdesivir works by stopping the virus from spreading in the body.
To fight COVID-19, experts hope to find an oral antiviral, like Tamiflu, or one that can be inhaled through a nebulizer, so that it can be given at home before patients need to be admitted to a hospital, says Helen Boucher, M.D., chief of the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center in Boston.
Another hope is that a cocktail of drugs that includes remdesivir could speed recovery even more. In August, the National Institutes of Health began a randomized, controlled clinical trial that tracked results of COVID-19 patients who'd been given remdesivir paired with interferon beta-1a, a drug used to treat multiple sclerosis.
In some patients, COVID-19 triggers a massive inflammatory response that can cause lung damage and lead to respiratory failure and even death. Doctors can now reduce the inflammatory damage with the powerful steroid dexamethasone. In a recent study published in the New England Journal of Medicine in July, the drug was found to cut the risk of death among hospitalized patients compared with patients receiving either oxygen alone, or invasive mechanical ventilation.
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Monoclonal antibody cocktails
Another potential drug is one you may have heard of as being part of the president's COVID-19 treatment: monoclonal antibodies, which have long been used in cancer therapy. Produced in a laboratory by cloning antibodies from patients who have had coronavirus, they're intended to boost new patients’ immune response to the virus.
Developed by Regeneron Pharmaceuticals, the experimental treatment in the headlines consists of a cocktail of two monoclonal antibodies called REGN-COV2, which are in clinical trials for both hospitalized and nonhospitalized patients infected with the coronavirus. Eli Lilly and other pharmaceutical companies are also testing their own versions of monoclonal antibodies — though Eli Lilly's trial has been paused to look into safety concerns.
Since President Trump received his Regeneron cocktail, Patel says she has “already had conversations with patients asking for what Trump had,” although the drug is officially available only on a “compassionate use” basis directly from the company. Both Regeneron and Eli Lilly submitted applications to the Food and Drug Administration for EUA recently, which would make the drug more widely available before clinical trial results are concluded.
But Beigel stresses the need for proceeding with clinical trials ahead of any wider use. “We don't know the efficacy and we don't know the risk of monoclonal antibodies, especially for patients hospitalized with COVID-19,” he says.
New ventilator protocols
Besides combatting COVID-19 with new drugs, doctors say progress is being made by rethinking the way they use mechanical ventilation to treat patients with low oxygen. A ventilator buys time for the lungs to heal from infection, but if it is managed incorrectly it can cause respiratory distress syndrome, or acute respiratory distress syndrome.
Proning, or placing a patient on their belly, is one technique being used to improve oxygen exchange, says Brian Garibaldi, M.D., associate professor of medicine at Johns Hopkins University School of Medicine and director of the Johns Hopkins Biocontainment Unit, “I honestly don't know yet if proning decreases mortality or gets [patients] out of the ICU faster, or prevents them from going on a breathing machine, but it is certainly effective for someone with really low oxygen levels."
Jonathan Abraham, M.D., assistant professor of molecular biology, immunology and structural biology at Harvard Medical School in Boston, says doctors are also avoiding mechanical ventilation by delivering oxygen via things like a heated and humidified high flow nasal cannula. However, Abraham adds, “I don't want anyone to believe mechanical ventilation should be avoided at all costs. The physicians taking care of patients will know when it is required and when the benefits outweigh the risks.”
Keeping pace for the future
Garibaldi says the number of new drugs in development is exciting. “Things continue to move at a mind-blowing pace when you think how the normal process of developing therapeutics happens,” he says. And for all the promise of new drugs and procedures, COVID-19 still has significant morbidity and mortality rates.
"This is a disease we are not ready to stop yet. We've come a long way, but we still have a lot to do,” offers Beigel, who notes that faster enrollment in clinical trials by COVID-19 patients will speed results. “I would encourage anybody that is hospitalized to participate in any clinical trial that is offered.
This story, originally published Oct. 15, has been updated to reflect new information.