Loretto Hospital seeking more people of color for COVID-19 clinical trial

January 11, 2021
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Health-care providers at Loretto are urging West Side residents to sign up for a COVID-19 clinical trial being held at the Austin hospital.

It’s critical for people of color to be represented in these trials so the medical community has a better understanding of how medications and other treatment work in every patient, the experts said.

Dr. Lois Clarke acknowledged “awful” things such as the Tuskegee experiment have happened but said safety protocols that include informed consent of all participants have been put in place to ensure patients are protected.

Loretto, which hosted a virtual town hall last week on COVID-19 vaccine and treatment trials, is seeking more participants for a clinical trial it is running.

According to Dr. Shilpa Pulluru, participants need to be at least 16 years old; not currently pregnant or breastfeeding; have not contracted COVID-19; and cannot be immunocompromised or have a recent history of cancer.

During last week’s “ask the experts” forum, the doctors discussed the safety and efficacy of the COVID-19 shots, the importance of getting the vaccine, and why it’s critical that Black and Latinx residents be included in clinical trials.

Moderated by Dr. Heather Bergdahl, Loretto’s chief transformational officer, the panel consisted of Dr. Ali Ahmed, president of Affinity Health, who also organized the administration of COVID vaccines at Loretto; Dr. Clarke, who specializes in emergency medicine; Dr. Pulluru, the hospital’s clinical research liaison; and Dr. Carlos H. Zambrano, an infectious disease expert.

Historically, Black people have not been properly represented in clinical trials. A clinical trial is a study mandated by the FDA that evaluates a drug or treatment’s effect on human health outcomes; it’s an essential part of proving a drug or treatment is safe and effective.

Participants in clinical trials are volunteers. Given the horrific treatment Black people endured in various trials such as the Tuskegee syphilis study, the stealing of Henrietta Lacks’ immortal cells and J. Marion Sims’ experiments on non-consenting enslaved women, there’s been a general mistrust of the medical community, Dr. Clarke said.

The COVID-19 vaccines that have been approved so far – produced by Pfizer and Moderna – have undergone rigorous review. More pharmaceutical companies, like Johnson & Johnson and AstraZeneca, are also developing COVID-19 vaccines.

Both Pfizer and Moderna require two shots administered 21 to 28 days apart; the same is planned for the AstraZeneca vaccine. The Johnson & Johnson shot will be just one dose.

Loretto’s vaccine trial will last two years, with participants expected to have seven visits over that time. Each trial visit will include going over the participant’s health history; reviewing medications being taken; and a physical exam by a licensed physician. Blood and swab samples also will be taken and sent to the pharmaceutical company.

It is a placebo-controlled double blind study, meaning there’s a 50 percent chance participants will get either the vaccine or a placebo. Neither participants nor doctors involved in the study will know which one is given; and a computer randomly determines whether a participant gets the vaccine or a placebo.

Participants will be given the immunization (or placebo) then observed for 30 minutes. Participants will be sent home with a device called an electronic vaccine report card where they will report how they feel everyday for 28 days and until their next visit.

During visits two through seven, which take less than an hour, the doctor will check for COVID-19 symptoms, review medical history and medications, and conduct a physical exam, followed by an antibody test. 

Participants will be compensated for their time and will eventually get the vaccine if they’re in the placebo group. More information on how to enroll in Loretto’s clinical trial can be found here, and the “ask the experts” event can be filled here.

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