CORONAVIRUS

University of Iowa researching COVID-19 drug Trump touted

Clinical trials 'months away' from reaching findings

Dr. Alejandro Comellas (foreground) is heading up a clinic at University of Iowa Hospitals and Clinics with Dr. Joseph Z
Dr. Alejandro Comellas (foreground) is heading up a clinic at University of Iowa Hospitals and Clinics with Dr. Joseph Zabner (left) and Dr. Raul Villacreses for patients after they have been infected with COVID-19. Photographed Aug. 5 outside of UIHC in Iowa City. (Liz Martin/The Gazette)

IOWA CITY — When President Donald Trump tested positive for COVID-19 earlier this month, he received an antibody cocktail produced by Regeneron Pharmaceuticals that he credited — at least in part — for his healing, called it an “incredible” medicine.

He also said in a video following his hospital discharge, “You’re going to get the same medicine, and you’re going to get it free, no charge, and we’re going to get it to you soon.”

Dr. Alejandro Comellas — principal investigator of the University of Iowa Health Care clinical trial site, among those nationally testing the Regeneron therapy — said the medicine isn’t publicly available outside clinical trials like those at UIHC.

He talked with The Gazette about how the therapy works and how Iowans might be able to access it.

Q: What is the Regeneron antibody therapy?

A: It’s an infusion of a cocktail of antibodies, two antibodies, that target the spike protein of the coronavirus. And what it’s trying to do is block the spike protein from attaching to the cells in humans.

Q: When did the clinical trial begin? And when did the UI get involved?

A: The clinical trial has been going on since early summer ... and we joined them in August. And basically there are two groups that we’re recruiting. People who are inpatients, hospitalized, and then people who actually have COVID but are outside and are at home. They’re in the outpatient setting.

Q: Does the UI have a goal for number of patients it wants to enroll in the Regeneron trial?

A: Right now we have a goal of 20 subjects, but we can increase if we are able to reach that number.

Q: And how many have you enrolled so far?

A: We have had a total of nine. We have had three inpatients and six in the outpatient setting.

Q: Are they all currently receiving the therapy?

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A: Because it’s a randomized trial, just by chance you can either end up with the cocktail or you can end up with a placebo, ... It’s a randomized clinical trial where you’re blinded to whether they’re receiving the drug, or they’re just getting the placebo.

Q: Is there a timeline for when the trial will end?

A: It’s still open. I know that we’re continuing to recruit, and we haven’t received any information that they have reached a point in which we will be closing.

Q: Are there specific criteria patients must meet to participate?

A: Yes. If you were on a ventilator or really sick, you were excluded. You needed to be diagnosed within 72 hours. So from the time of testing positive to being involved in the trial — receiving either the drug or the placebo — it needs to be less than 72 hours.

Q: So for it to be effective you need to take the therapy quickly?

A: We do not know. That’s why you have this trial that is in the outpatient setting, which is less-severe disease, earlier. And we have another group who are in the hospital, more severe. ... We speculate that the earlier, the better. But the reality is that we don’t have any data to support that.

Q: Do you have any evidence to show the therapy, in general, is beneficial?

A: There was some preliminary analysis that Regeneron showed some decrease in outpatient settings — decrease in symptoms and less visits to the hospital. But it’s very preliminary.

Q: How long could it take for a trial like this to produce results and become conclusive?

A: I would say that we’re still months away from determining the efficacy and safety.

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Q: Have you determined whether the therapy comes with any side effects?

A: We haven’t seen any reported side effects at this point. But that’s why the study continues. The safety profile continues to be evaluated, but at this point we have not had to stop because of any unforeseen circumstances.

Q: Given your involvement in this trial, what were your thoughts upon learning the president was receiving this?

A: I was not surprised that some people thought about this drug because there’s been a lot of speculation about the potential benefit. At the same time ... just because one person participated and they got the drug and they did really well doesn’t mean necessarily that the drug is either efficacious or safe. The only way we’re going to be able to find out about that is to continue the clinical trials.

Q: The president has said he believes this therapy will become widely available. Do you think that will happen?

A: Not right now ... We continue the trial, there has not been any discussions at this point about any FDA approval of these drugs on an emergency basis. I think everybody, right now, is doing the right thing, which is having the data and then determining whether it’s safe and also if it works. I would say that being available for everybody, whoever wants it, is also something that is not feasible.

Q: How is the Regeneron product different from convalescent plasma?

A: It’s similar in the concept because this is basically antibodies against the virus (but he explained the difference is that the Regeneron cocktail was engineered to pick the best antibodies).

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Q: Do people who participate in the trial receive compensation — like money?

A: Yes, people get compensated for participating in the trial.

Q: Where should readers call if they want to participate?

A: The number they can call here is 319-384-8610.

Q: How many COVID-19-therapy trials does UIHC currently have ongoing?

A: Half a dozen, not including the university’s vaccine trials.

Comments: (319) 339-3158; vanessa.miller@thegazette.com

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