Four clinical trials of a drug cocktail that President Donald Trump has proclaimed his miracle “cure” are underway on the University of Colorado Anschutz Medical Campus. And even while makers of the experimental therapy filed for emergency authorization use (EAU) the same day the president made his claim (Oct. 7), researchers say no evidence exists to back it up.
After recently falling ill with COVID-19, Trump’s health and medical treatment has taken center stage, placing therapies such as Regeneron Pharmaceuticals’ REGN-COV2 in the spotlight. Two studies on campus are looking at the antibody cocktail aimed at blocking SARS-CoV-2 replication as a treatment for COVID-19, and two studies are focused on the therapy as a preventive measure.
“I am not aware of any evidence that justifies the claim that REGN-COV2 cures COVID-19,” said Thomas Campbell, MD, professor in the CU School of Medicine (SOM) Division of Infectious Diseases and local principal investigator of two of the trials. Campbell, who has treated hundreds of patients since the COVID-19 pandemic hit Colorado and has overseen numerous trials in the search for treatments, shared his insights on the president’s case and therapies.
Here is some of what Campbell, SOM associate dean for adult health research, had to say:
Were you surprised to hear the president contracted COVID-19?
No, I’m not surprised. From what we have seen through videos and photographs of the various events and public appearances with the president, there has not been much regard for recommended practices to prevent the spread of COVID-19.
Thomas Campbell, MD
If he were your patient, what are some of the risk factors you might be concerned about?
Age, weight and male sex are risk factors for having more severe COVID-19. So people over 65 (Trump is 74), people who are obese, particularly people who are morbidly obese (Trump is “clinically” but not “morbidly” obese), and men are more likely to have more severe symptoms of COVID-19 illness. In terms of managing the illness, the one single thing that is monitored very closely and is very important is the level of oxygen saturation.
The president’s saturation level reportedly fell to 94% early on; what does that tell you?
It means that there is probably some pneumonia, meaning lower-respiratory-tract infection, and that is impairing the body’s ability to adequately supply oxygen to the blood stream through the lungs. It’s a fairly common thing to see that in COVID-19. Often people feel quite well even though they have very low oxygen saturations. (Trump has continually reported feeling “great” since the initial treatment.)
What concerns would you have about his fulfilling his duties as president?
I don’t know anything more about the president’s situation than anyone else who has read the newspapers. But we do know that COVID can cause a severe flu-like illness, which can cause fatigue, difficulty with concentrating, even some cognitive impairment. We know that COVID can affect one’s functional capacity, but that varies a lot from person to person. I wouldn’t be able to conjecture how it’s affecting the president.
What can you tell us about the drug cocktail Trump received?
He received a combination of two monoclonal antibodies (REGN-COV2) that are produced by Regeneron. These are antibodies that are engineered in the laboratory to bind to a very specific part of the spike protein of the coronavirus. By binding to that part, they block the replication of the virus, and they are being evaluated as an experimental therapy for people with COVID-19 illness.
What can you share about the ongoing clinical trials?
Regeneron is sponsoring several different studies. Four of those multisite studies involve our campus. One is for treatment of COVID-19 in the hospital setting. Another is for treatment of COVID-19 in the outpatient setting (Campbell is overseeing both trials).
Then there are two studies looking at the use of these antibodies for COVID-19 prevention. One is studying household contacts of people with known COVID-19 being led by Dr. Eric Simoes in the Department of Pediatrics, and another is looking at COVID prevention in nursing home outbreaks. That study is being run by Dr. Brian Montague in the Division of Infectious Diseases in the School of Medicine.
What are you finding so far?
In a press release issued by Regeneron on Sept. 29, results from a study with 275 participants were provided. REGEN-COV2 produced faster decreases in viral shedding in the upper respiratory tract. And among a subgroup of participants who did not have SARS-CoV-2 antibodies at the start of treatment, REGEN-COV2 led to faster resolution of symptoms compared to placebo. Side effects appeared to be uncommon and mild.
How was the president able to receive an experimental therapy?
Experimental therapies can be given on an individual case-by-case basis outside of clinical trials in what is called “compassionate use” (or an “expanded use” pathway through the Food and Drug Administration). Since we have clinical trials here, we wouldn’t have the need to request a compassionate use authorization.
What, if any, are the dangers of treating the president with this right now?
The information that has been made public so far about these antibodies is that they appear safe. I would say that the treatment itself, from what we know, poses little risk.
So, this is just an example of how disruptive
and potentially dangerous COVID can be when
we don’t use those tools that we know are effective
for preventing SARS-CoV-2 transmission.
– Thomas Campbell, MD
Tell us about the drug Remdesivir the president also received.
Remdesivir is a medicine that also inhibits the replication of the SARS-CoV-2 virus. It doesn’t affect the spike protein but instead inhibits the viral polymerase that is used to replicate the virus’s genetic material. It was a medicine that was in clinical trials, including some clinical trials conducted on our campus, that concluded back in May.
Based on the results of those clinical trials, it was shown that Remdesivir reduced the duration of illness and improved symptoms in people with COVID-10. The company that owns Remdesivir, Gilead Sciences, received an emergency use authorization from the FDA. Any doctors taking care of hospitalized patients with COVID-19 now can prescribe Remdesivir if they feel that it’s indicated.
When is it indicated?
Remdesivir is indicated for treating severe COVID-19 illness in hospitalized patients. It’s given by intravenous infusion, and it’s given usually for a five-day course. It’s helpful if it’s given earlier in the course of illness, and it’s most helpful in people with severe COVID. So, it’s something that is being used quite routinely in hospitalized patients. By definition, the president had severe COVID because he dropped his oxygen saturation.
He also received Dexamethasone. What does that do?
Dexamethasone is a medicine that has been around for many decades. It’s a very potent anti-inflammatory medicine. There have been a couple of studies, including a large randomized clinical trial conducted in the United Kingdom, that demonstrated that for people with critical COVID-19 illness, Dexamethasone provides a significant benefit, reducing the risk of death by over 30%. So that’s a pretty big reduction in mortality risk. Dexamethasone is only used for people with severe and critical COVID. There’s evidence that in milder COVID, that it might be detrimental.
Dexamethasone is used because a large part of the damage that is done to the lungs and other organs during COVID illness is due to an over-exuberant inflammatory response against the virus. And so, inhibiting that inflammatory response is one strategy to improve outcomes.
When will we know for sure that Trump is out of the woods?
We don’t know exactly when the president’s symptoms started, because the White House has not divulged that information. But some people, particularly people who have the risk factors that we talked about earlier, can take a turn for the worse because of that inflammatory response. That typically starts to kick in about seven to 10 days after the onset of illness. (The president’s chief physician called Oct. 3 “day three” of Trump’s illness.)
What else would you like to add?
I think it’s unfortunate that the president has contracted COVID. And it’s not just the president, but it’s now many people in the president’s close circle at the White House. We know from press coverage of various public events at the White House that the measures that we know are effective in preventing COVID spread (masks and social distancing) were not being used. So, this is just an example of how disruptive and potentially dangerous COVID can be when we don’t use those tools that we know are effective for preventing SARS-CoV-2 transmission.