SALT LAKE CITY — The world has been in a COVID-19 pandemic for over a year. While vaccination efforts have ramped up in recent weeks across the country, a large number of the population still remains unvaccinated and vulnerable to the virus.
As of Wednesday, 29% of adults in the U.S. were fully vaccinated and another 43% had received at least one dose. Until a large majority of the population is able to get vaccinated, the risk for spikes and surges of the virus remains, as well as serious illness from getting COVID-19.
That's why researchers at Intermountain Healthcare are helping launch a new study with the National Institutes of Health, along with several other scientists across the world, to examine effective treatments for severe cases of COVID-19, known as acute respiratory distress syndrome, or ARDS. The life-threatening condition makes the lungs severely inflamed and nearly impossible to maintain enough oxygen in a patient's blood — it is considered the most severe phase of a COVID-19 infection.
"While we work to get control through vaccination, we continue to need treatments," explained Dr. Samuel Brown, critical care physician and researcher at Intermountain. He's also the principal investigator of the phase 3 trial, entitled ACTIV-3 Critical Care.
To date, doctors have treated COVID-19 patients using Zyesami and Veklury(remdesivir). Now, the study will research the efficacy and safety of these drugs in hospitalized COVID-19 patients with ARDS.
"What's complex is that COVID itself, for any one individual, the risk is relatively low unless they have comorbidities. Now if you infect enough people, even low risk will lead to some substantial death and disability," Brown said. "But on average, the typical person infected with COVID has a nasty cold and gets better.
"If it were not so transmissible, it wouldn't be that big of a deal. But, unfortunately, it's very transmissible, so you get huge numbers infected and then you end up with large numbers that get very, very sick," he added.
Doctors have had success treating patients who suffer from less-severe cases of COVID-19 with these medications, but finding therapeutics for very ill patients has been difficult, Brown said. There isn't research to show that those with COVID-19 who have developed ARDS benefit from being treated with remdesivir — the study is hoping to answer some of these questions.
"So far, we've been struggling to find therapies that will work for the sickest of the sick, the people who are on life support treatments because their lungs are failing," he said. "ARDS … it's devastating. It can kill 20- 40% of the people afflicted by it, and the majority of survivors may take six months, 12 months, five years to recover from it; and some people, unfortunately, never do get back to their prior state of health."
Researchers and scientists are trying to move rapidly with the study to provide answers quickly to the public. With luck, it's possible results could be seen as soon as four to five months, according to Brown. However, if they encounter roadblocks — like not being able to get a large number of trial participants — then the process will be slower.
If the results provide evidence that remdesivir is an effective treatment with severely sick COVID-19 patients, the impact would be immediate considering the drug is already approved and doctors could start administering treatments right away, Brown explained. The benefits of the study could go beyond solving COVID-19 treatments, as well.
"There is a strong body of previous research that supports the use of these agents in ARDS, which is associated with substantial morbidity and mortality," said Dr. Gary H. Gibbons, director of the National Heart, Lung, and Blood Institute. "Not only is this an important trial in terms of potential new treatments for COVID-19, but it could open new understanding into the repair of damaged lungs following ARDS."
The clinical trial will be randomized, blinded and placebo-controlled. Additional, smaller studies to test different treatments will run concurrently with this trial, which will consist of about 620 patients at 50 sites across the nation. Trial participants will be randomly assigned to either get the drug or a placebo in one of four treatment plans — both Zyesami and remdesivir, Zyesami and a placebo, remdesivir and placebo, or placebo alone.
Hospitalized COVID-19 patients with acute respiratory failure who "require high-flow supplemental oxygen delivered by nasal cannula, mechanical ventilation, or extracorporeal membrane oxygenation" will be enrolled in the study, according to a news release. To start, a small group of 40 patients will be enrolled in the trial. If no safety concerns are found, the study will expand to a larger group.
But as vaccination rates go up and severe cases of COVID-19 decrease, it might be harder to get answers to these treatment questions as it might be difficult to find eligible study participants, Brown explained. It's a double-edged sword; the scientific community wants answers but simultaneously hopes COVID-19 is soon eradicated.
"It's really hard to get answers about COVID If nobody has COVID anymore in a given area. So we're both hoping that COVID goes away so fast we won't get answers. But recognizing that if COVID persists — and it seems like it is persisting, at least at different places around the country — that we'll be able to answer the questions as quickly as we can," Brown explained.
"What's so hard about COVID is you want this damn virus to be gone. We want to be done with it, and nothing would make us happier than to never have to do another COVID study for the rest of our lives," Brown continued. "The reality, though, is that COVID persists; and while it persists, we feel a moral obligation to bring trial access to patients to allow them access to these promising drugs in a scientifically, careful and safe and appropriate environment such as you see with a clinical trial, and as quickly as we can to get answers."