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When COVID-19 arrived in the United States, researchers frantically began testing existing drugs to determine if any could be used in the fight against the novel coronavirus. Months later, we connected with experts from University of Colorado Hospital (UCH), Centura Health, and Kaiser Permanente for an update on the treatments being researched in Colorado. What did we discover? That what normally takes years has been accomplished in a few months.
Note: There are three main categories for COVID-19 treatment. The first are antivirals, treatments that target the virus itself. The second are drugs that target the extreme immune response caused by the virus (this overzealous immune response can lead to life-threatening complications). The third are anti-inflammatory drugs that respond to organ failure, Acute Respiratory Distress Syndrome (ARDS), and other complications that arise due to the intense immune response.
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Ongoing Clinical Trials
How it works: An antiviral drug that inhibits the ability of the virus (Sars-CoV-2) to grow, remdesivir needs to be administered relatively early—fewer than 14 days after the onset of symptoms—before the robust immune response has time to kick in.
Update: After a National Institutes of Health (NIH) clinical trial in late April showed that remdesivir shortens recovery time, the Food and Drug Administration (FDA) issued emergency approval for the drug in COVID-19 treatment. Results from an expanded study are still pending; however, U.S. hospitals can use remdesivir prior to final FDA approval (this is called compassionate use).
Convalescent Plasma Therapy
How it works: COVID-19 survivors may have antibodies in their blood that learned to recognize and fight off Sars-CoV-2. Convalescent plasma therapy takes these antibodies and gives them to people currently ill with COVID-19. Researchers believe this therapy can improve chances of recovery by introducing viral warriors into the body before patients can deploy their own.
Update: Due to historical precedence and an extremely low adverse reaction rate, the FDA approved an expanded access program for convalescent plasma therapy. This means that hospitals across the country—including those in Colorado—can use it as long as they report the patient’s recovery data to the FDA for analysis. And thanks in large part to the early organization of the Colorado Convalescent Plasma Consortium, there is no shortage of access. “If you’re in the hospital and you have a COVID-19 positive test, you meet criteria because it is super liberal. You don’t even need to be on oxygen,” says Dr. Alexander Benson, pulmonologist and COVID-19 Operations Team lead for Centura Health.
How it works: Ruxolitinib—a drug used to treat myelofibrosis, a rare type of bone marrow cancer—could also potentially inhibit the inflammatory immune response that occurs in people with severe COVID-19.
Update: The University of Colorado Hosptial’s Ruxolitinib clinical trial, which enrolled 80 participants, started in early June. No findings have been released yet.
How it works: Sarilumab is a drug usually used to treat rheumatoid arthritis by blocking the IL-6 pathway, an active gatekeeper of the body’s inflammatory response. That leads researchers like Dr. Mercedes Rincon, University of Colorado Anschutz School of Medicine professor of immunology and microbiology, to believe it can possibly help prevent COVID-19’s overactive inflammatory immune response.
Update: This randomized clinical trial began on March 18 in collaboration with UCHealth and various hospitals (over 2,000 patients are enrolled nationally). While the trial began with a broad range of COVID-19 patients, it has since narrowed to only enrolling people on a ventilator. “What’s currently being enrolled is a little further along the spectrum of severity than what the ruxolitinib study is enrolling,” says Dr. Thomas Campbell, professor of medicine-infectious diseases at the University of Colorado School of Medicine.
How it works: Alteplase typically treats blood clots, strokes, and heart attacks. Researchers believe it can potentially improve the oxygenation and respiratory function (i.e. help them breathe) of advanced COVID-19 patients experiencing respiratory failure and ARDS.
Update: This randomized clinical trial enrolled 60 participants from National Jewish, University of Colorado Denver, and other U.S. hospitals. It began on May 14, with the results expected to arrive in November.
How it works: Acalabrutinib is regularly used to treat B-cell lymphomas and leukemias. Researchers are testing the drug’s success in helping patients recover from ARDS from COVID-19.
Update: In early June, the results of exploratory research by AstraZeneca (AZ) and the NIH were released. Nineteen patients were treated at Rocky Mountain Cancer Centers (RMCC) in collaboration with Centura Health, and two other U.S. hospitals. Most patients demonstrated significant improvements in oxygenation, often within a few days. The next clinical trial will test those results against a much larger sample size across the country. AstraZeneca is currently finalizing protocols and selecting sites, including Centura Health hospitals.
Hydroxychloroquine (and Azithromycin)
How it works: Hydroxychloroquine is an FDA-approved drug used to prevent or treat malaria and various auto-immune diseases including rheumatoid arthritis and lupus. Azithromycin is an antibiotic that’s commonly used to treat bacterial infections, including bronchitis and pneumonia. “There is some evidence [from previous trials] that azithromycin can provide benefit when given with hydroxychloroquine to people with COVID-19,” says Dr. Campbell.
Update: On Monday, June 15, the FDA revoked the authorization for physicians to prescribe hydroxychloroquine to treat COVID-19 outside of research studies. UCHealth is currently conducting four such trials: two inpatient and two outpatient ones, though due to press coverage, including President Donald Trump’s inaccurate claims on the drug, patients are increasingly hesitant to participate. “We worry that people are forming opinions outside of the science. We want to encourage people to enroll in trials so that we actually can get the definitive answer,” says Dr. Jean Kutner, professor of medicine at UCHospital.
How it works: Monoclonal antibodies are engineered to be more specific and much more potent inhibitors of the virus than body-generated COVID-19 antibodies being used in convalescent plasma therapy.
Update: A clinical trial in affiliation with UCHealth began mid-June. There will be two studies, one with people with severe COVID-19 who have been admitted to the hospital and the other for people with mild or moderate COVID-19 that don’t need hospital admission.
Upcoming Clinical Trials
Further exploration will expand on current clinical trials. Dr. Benson from Centura Health indicated that the next step for remdesivir research should include how the drug works with other antivirals. “There’s going to be some cocktail combination of drugs that people are going to get if they have COVID-19 and that’s going to be the key because they’re not going to progress to organ failure. And then if that can hold us off with social distancing, until we get vaccinations, then we’ll be in a totally different camp.”
The University of Colorado is also hoping that monoclonal antibodies will be useful in preventing, not only treating, COVID-19 in high-risk individuals. “They’re not in clinical trials yet, but will be very soon,” says Dr. Campbell.