Robert Salata, MD, discusses the ARMS-I clinical trial that will enroll clinical staff caring for patients with COVID-19.
Segment description: Robert Salata, MD, principal ARMS-I COVID Study investigator, program director, University Hospitals Roe Green Center for Travel Medicine & Global Health, discusses a clinical trial that will enroll clinical staff caring for patients with COVID-19.
Interview transcript (modified slightly for readability):
Contagion®: Thanks for joining us for another Contagion® coronavirus video.
Today, I'm joined by Dr. Robert Salata, who will be discussing the ARMS-1 investigational drug for COVID-19.
Thanks so much for joining me. My first question is, can you summarize this investigational drug?
Salata: It's been around for a while, since 2012.
In the mid-2000s, we were very enticed by the laboratory evaluation of this drug that gets at a variety of different microbial pathogens. It has potent activity against bacteria, fungi, and in this respect, we're looking at viruses.
Our colleagues have shown that this works very well in the laboratory against influenza and other respiratory viruses. On top of that, there was a publication in the summer of 2019 by our Chinese colleagues that looked at the activity of this antiseptic called CPC. It's quite like chlorhexidine, which many of your viewers will be familiar with. In the laboratory, this showed potent activity against other coronaviruses.
We didn't have COVID-19 around at that time, but against the first SARS [sudden acute respiratory syndrome], as well as MERS [Middle East respiratory syndrome] and other coronaviruses (that are common causes of the cold) it did show potent activity in parallel with this study which will describe in a few minutes.
We are undertaking studies at Case Western Reserve University with our colleagues, as they attain the capability of growing the virus in the laboratory. We will test this product definitively against this virus as well. But with that as a great start, and the fact that there really are not great preventative measures for COVID-19 right now, and because we need to preserve our workforce health care workers, this was the basis for our initiating this study.
This product contains this antiseptic. In our previous work—when it's sprayed into the mouth—we know through animal models that it does penetrate into the nasal area. That's important in terms of where this this and other respiratory viruses live. It also has what is called muco-adherent activity, meaning it stays bound to the nasal and oral mucosa. Therefore, it's ideal in this regard.
We did another one in about 40 of our bone marrow transplant patients to look at what effect this product had on the acquisition of very resistant bacteria in the oral area. In both studies— the first one, which was with 100 individuals that were otherwise healthy, and in the bone marrow transplant patients—it was very safe. There were no side effects at all. So that's important as a starter.
We felt going back to this investigation, that we wanted to provide something to our frontline health care workers. We think this will reduce the occurrence of COVID-19 and also shorten the course of disease, if they do acquire it.
That's what we're starting to do. It is a randomized, controlled, blinded crossover study, placebo controlled so that in the first 2 months, and we're going to study over 4000 individuals. Multiple institutions will eventually be involved because that's a lot of folks to recruit, we will randomize to either the placebo arm or the active compound.
It's sprayed into the mouth 3 times a day, it's very pleasant tasting, it's not a big problem. At the outset, we will measure antibodies against the COVID-19 virus so that we have a sense of what we call the prevalence of infection even though people may have been asymptomatic. But if they're positive by antibody testing, they will not be enrolled in the trial because they should be theoretically protected against COVID-19 going forward.
We will also test by antibodies at the very end and that will give us a sense of the incidence of new infections that are occurring in the population of health care workers. These are frontline, direct patient contact folks. Anytime they develop a respiratory illness, they will be evaluated. Testing for COVID-19 will be pursued with PCR [polymerase chain reaction].
We'll be able to account for how often they develop this and we'll look at both groups.
We will have control groups in 2 ways. One will be the placebo group versus active compound, although it's going to be crossed over as I mentioned, but we'll have the same individuals serving as their own control, because they'll move from one form of treatment to the other.
We anticipate that the periods of treatment will be 60 days a piece, and then the crossover will occur. We'll have an interim analysis at that 60 day period, and if we find that it's very, very effective, then we may stop doing it in our health care workers and make it available more broadly and secondly, begin to study it in other individuals that are at high risk for complications and death such as the elderly. Those vulnerable populations with chronic cardiac lung disease, active treatment for cancer, immunosuppression, pregnant women perhaps but probably will stay away from them at the end.
That would be our plan to escalate this to other groups ultimately, to see if it's effective as well.
This would be our ability to see if it really is preventative. There are other products that are being considered in the prevention manner, but this is a relatively simple and safe and we think going to be effective means to do this.
Contagion®: You mentioned that you have to head to the hospital later on today. I just wanted to ask as an individual who is going back and forth to a hospital environment, why is it so important for us to be looking at medical countermeasures for COVID-19 for our frontline health care workers?
Salata: Everybody has discussed the issues of the dwindling supplies of personal protective equipment, and other things that we can do to keep our health care workers safe and, on the job, because that's going to be important as this spikes up.
We have been fortunate in Ohio not to see the huge numbers of cases that have occurred in other areas like New York, New Jersey, Chicago, Detroit, among other places. It’s all about keeping our health care workers safe and at work and productive. We need them on the front lines, right?
Contagion®: Absolutely. Do you have any final thoughts or conclusions about your study or anything else related to COVID-19 that you want to share?
Salata: We want to do this as rapidly as we can. It's being finalized at the IRB level today. This is one of the fastest processes I've ever seen. But we want to roll this out. We'll have 2 other institutions initially involved with us. Because to recruit that many individuals will be a Herculean task, that that's what it will take to show efficacy. And that's what it's all about.
Contagion®: Great. Thank you so much for joining me and we really appreciate you taking the time to speak with us. We wish you luck with your research.
More information on the ARMS-I COVID study is available here.