As researchers continue to explore treatment options for patients hospitalized with COVID-19, trials for individuals with mild enough symptoms to not need hospitalization have also moved toward activation in recent months.
These trials seek to tackle COVID-19 earlier in the process when, in theory, antivirals and other treatment methods can more effectively shut down the virus’ growth.
One of the first such trials to open in the U.S. is an antibody trial brought forward by Eli Lilly & Company. Baylor Scott & White Research Institute is the first program in Texas approved to recruit and enroll for the trial, which is designed to evaluate the safety and effectiveness of Eli Lilly’s investigational medicine, LY-CoV555, in patients with mild to moderate COVID-19.
The study, referred to as the BLAZE-1 Study, is led at Baylor Scott & White by Robert Gottlieb, MD, PhD, who sat down to answer some questions about the trial.
Tell us a little more about BLAZE-1. What type of drug does this study use?
BLAZE-1 uses an experimental treatment called LY-CoV555. It’s an antibody therapy engineered from one of the first individuals to recover from COVID-19 in the U.S.
LY-CoV555 went through lab testing and those lab tests showed it had an ability to attach to the SARS-CoV-2 virus (which causes COVID-19) and keep the virus from infecting cells. This type of antibody is called a neutralizing antibody.
Now, it is in the clinical trial stage where sites like ours will study if it operates the same way when given to humans (rather than just in vitro — meaning in tissue culture).
This is an outpatient study. What does that mean?
The best time for any antiviral, whether it’s an antibody or any other therapy is probably going to be giving it as early as possible. However, due to how the pandemic progressed in the U.S., quite a bit of upfront attention had to first go to helping patients already hospitalized.
So, what is normally an end point became a starting point, and now we’re looking at options that help us intervene earlier and earlier with studies like this one.
With that context in mind, there are few different terms to know to better understand this particular study, which is a placebo-controlled and blinded, outpatient study. To break that down:
- Outpatient means it is for someone with COVID-19 who isn’t hospitalized. Their illness is still considered mild or moderate and they’re quarantining at home. Hospitalization is referred to as “inpatient.”
- Placebo-controlled means some participants will get a placebo. That’s so we have a comparative group. In this trial, it’s actually four to one randomization of active to placebo, so if there are 500 patients, 400 would receive a dose of this antibody while 100 patients would receive the placebo. In this case, there is a further randomization. Participants may get the placebo or one of the different doses of the treatment being studied (in this case we happen to have four doses we are examining).
- Blinded means that the participant doesn’t know what they’re receiving. That helps us keep the most balanced and neutral comparative group to really measure how the different doses perform compared to patients not receiving the experimental treatment.
If participants aren’t in the hospital, how do you give them this experimental medication? Is it a pill?
We’re fortunate to have a pretty intricate and battle-tested research program at Baylor Scott & White. We have a lot of infrastructure and knowledge in place to guide how to conduct different trials.
For this trial, we have created a system for infusing the patients where they can come in through an isolation pathway so there’s no exposure point for other patients, be seen in a private area that contains everything we might possibly need, and complete the infusion (about an hour) and the post-infusion observation (which is about 2 hours) without ever having to leave the room.
From there, the trial participant gets to go back home and resume the home quarantining they would be doing anyways.
What about follow-up visits?
It’s incredibly streamlined. We conduct all of the visits and check-ins through home health telemedicine visits.
How is the research team recruiting patients?
There are two different ways: First, people may see information about this study in media or on flyers in pharmacies or other places in the community. In those cases, the contact details included with that information are how people can reach out.
“Regardless of what the outcome of the trial is, to me personally, this process is already providing more insights into the virus than I had the day before, and tomorrow I’ll hopefully gather more than I have today.”
Another way is if we get positive results from someone a day or two after they’re tested. The study requires participants be within 3 days of receiving their first positive test result. But if we receive the test results and the patient consents to being contacted about the trial, we can get the process started. That’s where our coordinators come in. Every trial has research coordinators involved who are that first line of contact for a study. They speak with our potential participants, do some initial screening or ask questions that help us understand if they might qualify for a trial.
Those who qualify and consent to participate in the trial are then scheduled for their infusion and the process I outlined above is set in motion. Both the coordinators and research investigators (physicians and advanced practitioners) continue to perform integral roles after randomization.
What else should people know about this trial and COVID-19 research?
There are a two other parting pieces of information I think people should know.
One, with this study, I have seen the outpatient process create this wonderful sense of empowerment in people with COVID-19. They have this opportunity to have a few hours of just 1:1 contact with their trial team to ask questions that they have on their minds outside of the clutter of what they see or hear in media or other places.
From my perspective, I have also been able to ask them questions about when they started having symptom, how the symptoms presented, etc. There’s an added layer of information sharing and education that the pace of this pandemic hasn’t always afforded, clinically or within research.
So, regardless of what the outcome of the trial is, to me personally, this process is already providing more insights into the virus than I had the day before, and tomorrow I’ll hopefully gather more than I have today.
Second, I think it’s important for people to know is that while this pandemic may at times seem like it’s only going in one direction, every trial is progress. We are working further upstream, so we’re covering hospitalized patients, we’re covering mild to moderate patients, and we can start working on actually preventing it.
Finally, it’s important to remember that not every mode of prevention has to be a vaccine. Masks, physical distancing and proper hand hygiene all serve this same purpose. Testing, in my view, falls into the same category as a tool for prevention.
There are things we can do right now, things in our control to help us push past this disease. It’s going to take everyone working together toward that common end result, and I have faith and confidence in our ability to get there — together.
Interested in learning more about this trial? Call 888.50RESEARCH.
About Baylor Scott & White Research Institute
Extending investigational expertise across more than 50 specialties areas, Baylor Scott & White Research Institute provides the business and regulatory infrastructure to accelerate medical breakthroughs and innovative new treatment models through clinical and translational activities. Baylor Scott & White Research Institute is present at sites and centers across Baylor Scott & White Health and maintains nearly 2,000 active trials each year. Learn more about ongoing research efforts.