DURHAM, N.C. -- A new study led by the Duke Clinical Research Institute is looking at whether three existing medications would treat mild-to-moderate COVID-19 effectively. (More information on the study is available here.)
The three repurposed medications, already approved by the U.S. Food and Drug Administration for other uses, are:
- Ivermectin, used to treat parasitic infections;
- Fluticasone, an inhaled steroid commonly prescribed for asthma and chronic obstructive pulmonary disease; and
- Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), often prescribed for depression.
On Tuesday, institute executive director Adrian Hernandez discussed the study with reporters in a virtual media briefing, where he touched on the need for COVID-19 therapies and making it easy for people across the country to take part in the study.
Watch the briefing on YouTube.
Here are excerpts:
On the importance of testing COVID therapies
“We are in another surge here and it’s important to get answers for people who have mild to moderate COVID-19. What has been set up is a platform that will allow people anywhere across the country to join together to get those answers.”
“As we see COVID-19 surge, how can we actually address those issues by understanding what drugs work the best way and the easiest way for people to take at home if they, unfortunately, get COVID-19. We’ll be able to evaluate a number of different drugs that have a proven safety track record.”
On why the clinical trial matters now
“We are all interested in making sure we protect and prevent people from getting COVID-19 through vaccination and other efforts, but there are going to be cases when people get COVID-19 either through breakthrough cases or because someone hasn’t been vaccinated.”
“We have new variants that have developed over the last several months and we need to understand what are the best treatments that will make people feel better, faster, and also prevent them from going to the hospital or having any other poor outcomes.”
On the value of a therapy for mild symptoms
“One of the lessons that we’ve learned around COVID-19 is that people may develop mild symptoms early on, and it’s very hard to predict whether they will develop worse outcomes. Once they get into the hospital the cascade really accelerates. It’s really hard to treat COVID-19 at that stage.”
“What we need to do is tackle this issue very early, before they have worsening symptoms or before they go into the emergency room or hospital.”
Treatments already exist for severe COVID-19 infections. What is the difference here?
“They certainly can be helpful for people who have severe COVID-19 cases. But there are two issues we’re trying to address. One, those therapies can be too late; tackling the disease early is important. The second thing is, they may be hard to administer. Some require IV infusions -- that’s not necessarily convenient treatment for people with mild to moderate COVID-19. Earlier treatment, at home, is a better answer if we can find out what the right drugs are that can do so.”
On including underserved and rural communities in this trial
“Because this trial is allowing anyone to enroll anywhere in the U.S. by phone or online, we can really reach the rural population. You don’t necessarily have to be close to a major (medical) center like Duke. You can be anywhere in the U.S. and enroll.”
On age restrictions
“Anyone 30 and older can enroll as long as they have symptoms related to COVID-19.”
On studying long COVID-19 infections
“That is an important issue. Many of the early studies around COVID-19 centered on preventing people from going into the hospital. Here we’re going to also be looking at long COVID. Whether these treatments prevent possible hospitalization and death, but also the impact on long COVID, out to three months. There may be some early treatments that may have an impact, but whether it prevents long COVID is still uncertain.”
On how data will be collected from people remotely
“There are two ways we’ll collect data. One is directly from participants. They will fill out surveys online, information about their health and outcomes. The other mechanism: If for whatever reason someone isn’t able to participate online, we can call them directly to collect the same information. This way, people don’t have to leave their house to give their data for the study.”
On concerns related to using Ivermectin
“It really should only be used in the setting of a study so that we can understand the potential benefits and risks. The clinical guidelines do not currently recommend Ivermectin for care of COVID-19 directly because we don’t have those answers yet. So our recommendation is to only evaluate it use it in the setting of a clinical trial.”
On the importance of treatments along with prevention efforts like vaccines and masking
“What we’ve learned around COVID-19 is there are going to be different surges and there’s a likely chance COVID-19 will be around just like the flu. So while we want to have a strategy to prevent COVID-19, just like we want to prevent flu epidemics from happening, we also have to recognize there has to be treatments for it. It’s important to have treatments that work early and effectively so they can prevent the ongoing transmission of COVID-19 within communities.”
Meet the expert:
Adrian Hernandez, M.D.
Adrian Hernandez, M.D., is a cardiologist, vice dean of the Duke University School of Medicine and executive director of the Duke Clinical Research Institute, where he oversees clinical research programs, clinical trials and clinical education.