Texas hospitals are leading the way in clinical trials of COVID-19 vaccines and treatments

AUSTIN (KXAN) — Austin Regional Clinic and Baylor Scott & White are leading the way in research for COVID-19 vaccine and treatment trials.

Baylor Scott & White Research Institute Clinical Trial

The first two patients in the world were enrolled and treated at Baylor Scott & White Research Institute for a clinical trial that tests the safety and effectiveness of a potential new treatment option for COVID-19.

They are part of the ACTIV-3 clinical trial in Dallas, which was just launched by the National Institutes of Health (NIH).

The trial is testing a neutralizing monoclonal antibody manufactured by Eli Lilly and Company for hospitalized patients with COVID-19.

“This particular one [clinical trial] and a number that will come down the line, come from patients that have been infected with COVID, have recovered and have developed an immune response to it which is what the antibodies are,” said Dr. Michael Mack, Chairman of Baylor Scott & White Research Institute.

Dr. Mack says the ideal patient for this trial is someone who is hospitalized and in the early stages of COVID-19, but not sick enough to be on a respirator.

The treatment is an infusion that is administered through an IV over a two-hour period. The first two patients to receive it haven’t experienced any side effects so far.

“They both tolerated the antibody without an allergic reaction, but it is too early to tell if it had a benefit on their virus or not,” Dr. Mack said.

Dr. Mack says it will take several days to determine the impact on the patients’ health. Patients who are hospitalized with confirmed cases of COVID-19 may volunteer for participation in the study. Participants will also receive standard care for COVID-19, including the antiviral Remdesivir. 

“Adaptive clinical trials like this one which use a single platform to test multiple promising therapies quickly are examples of the strength that comes from close collaboration between colleagues and scientists across different centers and countries. We are proud to have this trial available at Baylor Scott & White,” said Uriel Sebastian Sandkovsky, MD, MS, Baylor Scott & White’s principal investigator and an infectious disease physician on staff at Baylor University Medical Center.

The ACTIV-3 trial will only take place at 400 select hospitals worldwide that are part of National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI) clinical trial networks.

Austin Regional Clinic Vaccine Trial

Austin Regional Clinic (ARC) is now recruiting 250 ARC patients from across Central Texas to enroll in a late phase Pfizer clinical trial. It is intended to prove the safety and efficacy of a COVID-19 vaccine, which will potentially allow Pfizer to be the first to bring a vaccine to market.

Cara Kunkel is a nurse at ARC and is ready to get involved in the vaccine trial after seeing the impact of COVID-19 on the Central Texas community.

“I feel for the patients who are dealing not only with chronic health problems, but some of them are becoming COVID positive and actually fighting for their lives,” Kunkel said. “It is something, as a nurse, that I feel like I should do for the community to serve them better, to be able to get the vaccine to them is very important.”

Being a front-line worker makes her a good candidate for the trial. Researchers are looking for ARC patients who are 18 years of age or older and who have high-risk exposure to COVID-19.

“This study offers an opportunity to be a part of history and benefit humankind. There are 7 billion people in our world who will need access to a vaccine to prevent COVID-19 infection, and ARC Clinical Research is thrilled to have a role in bringing a vaccine to Americans,” said Jeff Repper, director of ARC Clinical Research. 

The participants will have to go through a special screening to qualify. If selected, the participant will get either two doses of the vaccine or a placebo. Additionally, there are nine visits to the doctor to measure the safety and efficacy of the vaccine.

“This is not injecting the virus itself or a piece of the virus. This is studying the RNA of the virus and reproducing it and introducing that in a vaccine so our immune system can recognize it and think it’s the virus, react to it and form immunity to it,” said Dr. Anas Daghestani, CEO of ARC.

There is no solid timeline for the roll-out of a vaccine, however some researchers say we could see a vaccine by the end of the year.

“If the initial results are promising I can see this accelerating two to three months to FDA approval. I cannot speak to how long it will take Pfizer to make it available across the country,” Dr. Daghestani said.  

Participants will be compensated for their time and contributions to the clinical study. All COVID-19 vaccine clinical trial services will be delivered at ARC Clinical Research Wilson Parke, located at 11714 Wilson Parke Avenue, Suite 150 in Austin’s Four Points neighborhood. 

To learn more about the vaccine study, you can visit their website.