VIDEO: NIH-funded infectious disease expert discusses convalescent plasma, remdesivir, corticosteroids, and the COVID-19 vaccine timeline.
The following has been edited for clarity and length.
Patient Care: Good morning. I'm Grace Halsey, Senior Editor of Patient Care Online. And our clinical focus in August is traditionally on immunization, leading into the fall school semesters into flu season and to increasingly bad weather in many parts of the United States.
Today I'm talking with Roger MacArthur about several immunization- and COVID-19- related topics including his institution’s involvement in the use of the antiviral remdesivir and also clinical trials of convalescent plasma for the treatment of COVID-19.
Dr MacArthur is a professor of medicine the division of infectious diseases and the office of medical affairs at the Medical College of Georgia at Augusta University. He is an NIH-funded researcher and before arriving at the Medical College of Georgia. Dr MacArthur headed the Wayne State University AIDS clinical trial program. He's widely recognized as an authority the development of antiretroviral treatment.
Patient Care: You moved from Wayne State to the division of infectious diseases in Augusta about 4 years ago? What was your focus when you arrived and how has COVID-19 shifted that focus for you?
Dr MacArthur: Well, as you mentioned, I've done some research with HIV. And so, I expected when I came down here to continue that and to a large extent I have, but I've also broadened that research as has the NIH, to look at other viruses—first influenza virus and now, of course, COVID-19, or SARS-CoV2. I also do a lot of teaching down here. In fact, over half of my time is spent teaching our first- and second-year medical students.
Patient Care: How has your day-to-day activity changed?
Dr MacArthur: It's been changed substantially. So, a number of months ago, my division chief Dr. Joe Vasquez, put into place a separate COVID-19 service for infectious diseases. That was so we wouldn't get overwhelmed by COVID-19 on the regular consult service, where we have responsibilities to take care of other patients in the hospital, to see them in consult, as well as to train our fellows and residents and students in general infectious diseases.
So, we would split the COVID-19 consult service amongst the faculty, spending about a week or so at a time on that service. And I want to emphasize that infectious diseases, our faculty, were very active in that role. But we were behind the front lines, so to speak. We weren't the ones in the emergency department making decisions about admitting and we weren't the ones taking care of the critically ill individuals in the ICU, or for that matter, even the ones on the floor. That was done by our academic hospitalists. What we did was to put into place very good lines of communication. We would make daily phone calls, for instance, to the ICU group, to the hospitalists, and we would make decisions about which drugs were best to be treated, who would get treated, what a good approach would be and of course, as you can imagine, that would change over time.
So, for instance, initially, we were using a lot of hydroxychloroquine; everyone was around the country. We were never very impressed with its efficacy and we don't use that anymore. We had some toxicity associated with it as well. And then, as you mentioned, the FDA granted emergency use authorization to remdesivir. And we were involved in deciding who would qualify for it, who could receive it, because it is in relatively limited supply. And we were also taking the lead on consenting the patients, or at least getting permission to use it or getting permission from their legally authorized representatives.
Even before we had remdesivir we had convalescent plasma. We were participating in a protocol done through the Mayo Clinic; hundreds of sites around the country we're doing this, and we've probably put 40 or 50 individuals on convalescent plasma
Patient Care: What has been the experience with the response both to remdesivir and to the convalescent plasma?
Dr MacArthur: Well, it's hard to say, because 40 may seem like a lot, but it was not done in any kind of controlled setting. In other words, we didn't randomize patients and put some on standard of care and other medications and the others would get the same plus convalescent plasma. Initially it looked very promising using a very non- scientifically, unmatched previous population. It looked like it was making a big difference in survivability. Subsequently, it didn't look as good. Those data really have to be analyzed on a national level. They're not out but one thing I can say is it was very safe, there was no harm to giving the convalescent plasma
Remdesivir is also very hard to say if it was efficacious. The study that was published in the New England Journal of Medicine showed relatively modest activity of it or relatively modest benefit for some individuals who were not critically ill. So, for instance, it shortened duration of hospitalization by about 4 days from 15 days to 11 days. But that's kind of hard to notice on an individual basis, whether it's making a difference. So, we started to give the drug at an earlier point in time. But those patients were, of course, not as sick. They got better, but did the drug do it? Or, would they have gotten better anyway? it's really very hard to say.
Patient Care: Without the worldwide data we don’t know about the true efficacy or impact the drug is having. And yet we have it available. And it's at least an early tool in a toolbox that it isn't very full yet.
Dr MacArthur: That's exactly right. And the other one that we are using a lot now, that has had some success worldwide, is dexamethasone. The corticosteroids seem to be a benefit, not only in lessening the severity of the complications of the disease, but especially in treating individuals with the with ARDS—acute respiratory distress syndrome.
Patient Care: I’m going to shift gears away from the disease itself to the vaccines. So, there are, I believe 5 top contenders now in the United States and human trials for the first COVID-19 vaccine. Several are using traditional development methods. Several are being developed on new platforms.
In terms of time frame for delivery of a safe and effective vaccine against COVID-19, what are your realistic thoughts on that time frame?
Dr MacArthur: Well, I think it's probably going to be a year away. And I know there's a need for the vaccine. But I really want to emphasize it's not a good idea to rush a vaccine into all of us. We want to make sure—and we [Medical College of Georgia] we're not participating yet in any of the vaccine trials. But we need to make sure, and I say “we” in terms of those who are doing the vaccine trials, we need to make sure that the vaccine is safe. And there's enough concern about other vaccines and in the United States especially. And we really want to do the trial right; 30,000 people is a good large number. But we also want to make sure that we have a diverse population. We want to make sure the vaccine works for all of us. And the only way to do that is to make sure that the population that volunteers for the trial is diverse. For instance, over half of the individuals with COVID-19 are African American. That's the United States. And we need to make sure that we have adequate numbers of African Americans, Hispanic Americans, and so forth in the trial.
Patient Care. I believe that there has been stipulation by the FDA in the vaccine clinical trial protocols saying, "You must have a representative sample of those who are contracting the disease and those who are greatest at greatest risk of the disease."
And I guess that's another thing that we won't know for sure, until the numbers are in.
Dr MacArthur: That's right. And you mentioned there are about 5 vaccines that are close to being in trials or are in trials. There is some speculation that there might need to be more than one vaccine. They're going to target different parts of the virus. And we may be seeing, a year from now, an approach of using 2 or more of these vaccines, a cocktail of vaccines; in fact, many of the vaccines will probably require 2 doses, perhaps separated by a week or something like that. So, we'll have to see how it goes. And it just takes time to do these trials.
Patient Care: What would be the ideal amount of time after which somebody receives the vaccine to see if there's going to be any type of an adverse event—and not in the immediate aftermath of a shot, but over time?
Dr MacArthur: Typically, a few months to a year or more, but it will take not only a number of months but also tens of thousands of individuals getting vaccinated before we can have a better understanding of the side effect profile. There are differences between the very serious adverse events associated with some vaccines, like paralysis that's not likely to be associated with these vaccines, and the typical predictable, uncomfortable reactions like headache or muscle aches, low-grade temperature, things like that. But we'll have to collect all those data.
Patient Care: My last question is, if I were to start a sentence with “Flu season and COVID-19…” how would you finish the sentence?
Dr MacArthur: “….may not be as bad as we think it's going to be.”
And I say that because now that more and more of us are wearing masks and practicing social distancing, it's quite likely that that will have a benefit in reducing the spread of influenza as well as the documented benefit of reducing the spread of COVID-19. It’s going to be chaotic, no doubt, to some extent. The symptomatology of influenza and COVID-19 overlaps somewhat. So people will continue to get sick and they will be evaluated in the hospital for both of those conditions, influenza and COVID-19, but we'll also be looking to see if they have infection with other seasonal viruses like human metapneumovirus or RSV, respiratory syncytial virus. It will be a busy season, but again, masks may make a big difference in reducing the numbers.
Patient Care: I know you're involved with plans to bring students back to your campus. How is that all going?
Dr MacArthur: Our students are back, our medical students and dental students are back, as are the undergraduates and it's going very well. We spent a lot of time putting a lot of thought into how to make the learning environment safe. And we've done it. So, we're very pleased about that.
Patient Care: That's great. It's very good news, given some of the media we've just seen recently.