Dr. Katya Corado and Dr. Lance Okeke are concerned about what they see as a hesitancy among members of the Latino and Black communities to participate in COVID-19-related studies, a reluctance they say is often rooted in mistrust of the healthcare system.
Fortunately, the infectious disease specialists are in a position to do something about it.
Corado, who is Peruvian-American, and Dr. Lance Okeke, a Nigerian -American, are leading a clinical trial as part of the Rise Above COVID movement. It is an effort that aims to find treatments through the ACTIV-2 Studies, which stands for Accelerating COVID-19 Therapeutic Interventions and Vaccines.
The clinical trial is focused on people who have COVID-19 and are experiencing symptoms but are not hospitalized, and it is sponsored by the National Institution of Health (NIH).
Get Tri-state area news and weather forecasts to your inbox. Sign up for NBC New York newsletters.
Corado is a co-lead investigator, infectious disease researcher at the Lundquist Institute at Harbor-UCLA Medical Center who spent about 10 years conducting clinical research related to HIV. Within the last 18 weeks, however, she’s focused her efforts on addressing clinical research in the prevention and treatment of COVID-19.
Based in Los Angeles, Corado works at safety-net hospitals, which treat patients regardless of their insurance status. She deals with a majority of Latinos who are mainly Spanish-speaking and some who are undocumented.
“The reason I work here is because I myself am an immigrant to this country,” she said. “I was born in Peru and came to California when I was 10. So much like many of our communities, our parents make this huge sacrifice so that their children have the ability to go to school and educate themselves and that was really my path. And so I came to love medicine.”
Much like Corado, Okeke is fighting against COVID–19 and also making the effort to address racial injustices in the medical system as an assistant professor of medicine in the Division of Infectious Diseases at Duke University. He is the principal investigator for the ACTIV-2 trial at Duke.
He communicates specifically with Black communities within Durham and Raleigh in North Carolina through forums such as churches.
While working on the ACTIV-2 study, Corado and Okeke are particularly focused on getting more Black and Latino participants by getting involved in their local communities.
"As a Black infectious disease doctor, I felt the obligation of engaging with marginalized communities, in my case, the Black community through Black churches and locally in Durham and Raleigh, and many forums over the course of the last 21 months," he said. "The fact that we've been able to mobilize [and] connect with our communities in longitudinal ways that we haven't before was really, really inspiring."
ACTIV was introduced by the NIH in April 17, 2020, in an effort to coordinate research strategies for prioritizing and speeding the development of the most promising treatments and vaccines. There are multiple clinical trials from ACTIV-1 to ACTIV-associated, specifically designed to test a series of treatments.
The study for ACTIV-2, as promoted by the Rise Above COVID movement to inform and get communities engaged, is in place across the country, including California, New York, Massachusetts, Illinois, Texas, Florida, Washington, Pennsylvania and the New England area.
One of the treatments that patients are likely to receive in the clinical trial is an infusion of a monoclonal antibody, which is made in the lab and is designed to attach to the coronavirus. Researchers can see if the antibody is able to prevent the virus from entering and harming cells once it's inside the body.
Okeke explained that while antibodies are naturally produced to fight off disease-causing agents, monoclonal antibodies are synthesized in the lab to mimic such antibodies.
“These antibodies are very specific to the organisms that each pathogen that comes into our body," Okeke said. "Once we have identified the antibody structure [and] the structure of the composition of the antibody against the pathogen, we can actually replicate that in the lab.”
“And we can say, OK, well instead of having just five or 10,000 of these antibodies circulating, if we concentrate them and get the best antibodies against this specific virus, can we get this mass-produced antibody that our natural immune system has made specifically to fight this virus, replicate that many times over and infuse them to people that are sick from the virus so that it can almost serve as like a hyperimmune booster.”
Monoclonal antibodies are not substitutes for vaccines. While COVID-19 vaccines help prepare the body’s immune system if exposed to the virus, monoclonal antibodies boost the immune system after the person is already infected, preventing the virus from getting worse. However, Okeke said that there are indications of prevention among the antibodies.
“So one of the antibodies available through emergency use authorization is actually authorized to give to people who have been exposed to COVID but don't have it yet, because we know that these antibodies can actually prevent the viral infection,” he said. “So if it's infused in someone that is at high risk after they've been exposed, it can prevent them from actually getting infected from the virus."
If all of our immune systems have the capability to fight off COVID-19, what does identity matter in the conversation? For Corado, identity, especially that of gender and racial identity, has everything to do with it.
"White men are really wonderful at standing up and saying, yep, I want to be part of this trial,” she said. “Where we're not so wonderful is our communities, our Latino communities, our Black communities. It's much harder to have a good representation of our communities of color in clinical trials.”
According to a study conducted by the CDC, deaths caused by COVID-19 infections are generally higher among communities of color. Those infected with COVID-19 and identify as Black or African American, non-Hispanic persons are 2.6 times more likely to be hospitalized and 1.9 times more likely to result in death, while those who identify as Hispanic or Latino persons are 2.5 times more likely to be hospitalized and 2.1 times more likely to result in death.
“Every human has the same organs but there are differences that exist both genetically and socially with the different communities that we have to account for when we provide treatment for a patient,” Corado said.
Corado gives an example in which she’s treating a patient who is a 60-year-old, undocumented, Latino man diagnosed with diabetes. While her ideal medical advice would be to recommend a healthier diet, fitness routine and prescription medication as needed, this may not be simple if the patient is juggling a busy work-life and only has access to certain types of foods.
“How the identity works into that is that we still have very distinct roles in this country,” Corado said. “You can agree with the roles or you can not agree with the roles. It doesn't matter when it's actually happening in front of you. So you have to modify your approach to someone's health, depending on where they come from and depending on what their life circumstances are.”
Okeke also said that communities of color are more impacted by COVID-19 based on their underlying health conditions.
“Intrinsically, there's nothing genetic that says that Black people just don't deal with COVID as well,” he said. “We know the reason why we're seeing more hospitalizations and deaths in that population is because of all the comorbidities that are more prevalent in the Black community like obesity, diabetes, [or] hypertension and the like. And we know that those internal risk factors [cause] bad outcomes for COVID-19.”
The unique backgrounds of such patients bring about more need for representation in clinical trials to prove the treatment’s effectiveness and to ensure the trials are not to be overwhelmed by statistical data that only supports the white demographic.
“We need to know that we've tested these medications, these treatments in those populations of people with high levels of comorbidity to see that the differential effect, of how effective these treatments, are the same across an ethnic-national genetic makeup,” Okeke said. “I think that's the key thing, is to make sure that when we're looking at our data and reporting it, that we can feel good [and say] 'Yes, we've tested a number of people but we've tested enough Black people to know that it works in our population as well.'”
Okeke and Corado both work in areas that are specific to the demographic in which they aim to develop more representation within the clinical trial. They agree that the lack of more representation from communities of color is a result of a lack of trust in the medical industry. They say people are worried not only about the novelty of the COVID-19 pandemic but also the racial disparities that are prevalent within healthcare.
Their roles and backgrounds help push connections with communities to regain such trust.
“Being a woman of color, working as a physician working in an academic institution, can be a very lonely place because there's not many of us,” Corado said. “And the overwhelming need for our communities, specifically the Latino community here in Southern California to have a person that they can trust, that can see that looks like them, that speaks their language, that knows their culture, is really important.”