Gloria Salinas, Managing Director, Economic Development
Time is of the essence in the global race to find a preventative therapy for COVID-19.
Leading Dallas Region doctors at renowned research institutions, including Baylor Scott & White Research Institute, and UT Southwestern Medical Center for Research, who have joined the race say it’s just a matter of time, perhaps even just a few more months before a preventative therapy is developed.
“We are certainly leading the way in getting these trials up and running because we have the infrastructure in place,” said Jaime Walkowiak, Chief Operating Officer for Baylor Scott & White Research Institute. “I believe a treatment or preventative therapy we are researching today will make it along in the next few months before a vaccine is created. I hope that anyone reading this and keeping a pulse knows that there is hope. If you become sick, there are therapies to target COVID-19 symptoms, and that hope is important for our community to have.”
Both hospitals are participating in clinical trials for preventative therapies to help COVID-19 patients, but the trials require time. The studies created by pharmaceutical companies and managed by the Federal Drug Administration (FDA) require participation of COVID-19 patients, or even frontline medical staff treating patients, and time to collect data on how individuals respond to the treatments. The data collected is sent to the FDA to determine if the results are effective enough to be released as a treatment.
Baylor currently has three pharmaceutical industry trials up and running along with one investigator-initiated research study that is 100 percent philanthropically funded by the Baylor Scott & White Dallas Foundation, the system’s nonprofit organization supported by more than 12,000 individuals, corporations, and private foundations.
“The time it took to draft the protocol, receive Baylor Scott & White Institutional Review Board (IRB) and FDA approval, enroll the first participant, and give the first dose was 10 days. That’s as fast as it can be done,” said Dr. Peter McCullough, Principal Investigator for the investigator-initiated frontline prophylaxis study, titled Hydroxychloroquine in the Prevention of COVID-19 Infection in Health Care Workers.
At any given time, there are some 2,000 research projects underway across the Baylor system. Today, Baylor is working with all doctors – from oncologists to cardiologists – across the system to focus on treatment trials for COVID-19 patients in moderate, severe, and critically ill stages of the virus. Baylor’s Institutional Review Board (IRB) is now meeting daily to expedite the review process for clinical trials in order to decide in which trials the institute wants to participate.
“At the time [the investigator-initiated research study] was developed, this was a first-of-its-kind study in Texas – and one of the first in the nation,” Dr. McCullough said. “So as a health system, and as the largest not-for-profit health system in Texas, we had this point of view: since the pandemic was not so severely affecting us here as it was in New York, we have an opportunity to embark on a prophylaxis study. If we can help to contribute to the ongoing global effort to prevent and treat COVID-19, that exemplifies our mission.”
The study was conceived in late March, as Baylor doctors recognized that health care workers could be at higher risk of infection with COVID-19, and they could also potentially be carriers of the virus and spread it to patients or to fellow health care workers. The study examines the use of Hydroxychloroquine as a prophylactic option, specifically for frontline health care workers exposed to COVID-19. The study seeks to determine if Hydroxychloroquine would help mitigate the severity of infection or potentially prevent infection in health care workers with high-risk exposure to patients infected with COVID-19.
“We have been working around the clock to review and make these types of opportunities available, and we are grateful to the donors that made this possible,” said Dr. McCullough.
The dose of Hydroxychloroquine used in this study is similar to the dosage that is used to prevent malaria. Hydroxychloroquine is given once a week for a total of seven weeks. The first day of the first week, participants are given 400 milligrams twice per day, which is a high, or “loading” dose. Then, for the remaining six weeks, the dose is 200 milligrams once a day. During and after the seven weeks of receiving Hydroxychloroquine, the participants undergo continued specimen collection.
“We use real-time PCR-based in vitro diagnostic tests for the identification of SARS-CoV-2 virus — the virus that causes COVID-19,” Dr. McCullough said. “Specimen collection includes the use of nasopharyngeal swabs.”
While doctors race to stand up clinical trials, studies, and collect data around the clock, COVID-19 takes its time as a slow progressing virus that shows slow improvement in patients, so it takes longer to get results, said Dr. Mamta Jain, UTSW Professor of Internal Medicine and Director of the HIV Research Institute. Only mild cases of the virus turn around quickly, she said.
“These trials are enrolling at warp speed, and we have been so inundated with trials and studies that it became overwhelming. We set up a committee to help review trials and decide what we are able to participate in,” Dr. Jain said. “We only have so much manpower, and we have to think about what is promising.”
The need for more rigorous data is critical for doctors, patients, and reopening the economy.
“I feel very uncomfortable because I don’t know what to offer patients. There is no proven therapy yet, and it’s going to take time,” Dr. Jain said. “I think once we have something that’s proven, then things will relax a bit because I will have something I can treat a patient with that will help.”
Dr. McCullough said it has been tough to witness the virus’ impact on the economy as well as in places such as New York.
“The pandemic in Dallas has been night and day from New York,” he said. “In my opinion, the only way to really understand what is going on and to effectively respond to the pandemic is to report daily hospitalizations. Although positive tests and deaths are the focus of media attention, the really important bellwether is the rate of hospitalizations per day. Once we know that, across the nation, we can allocate our resources better and distribute protective equipment, ventilators, and other supplies to where they are needed. I believe so far, this has been a great missed opportunity.”
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Learn more: Baylor Scott & White Foundation
Protocol Summary for Hydroxychloroquine in the Prevention of COVID-19 Infection in Health Care Workers Study
Participants consisting of Baylor Scott & White health care workers, who initially test negative based on the nasal RT PCR test for SARS-COV-2, are organized into two groups:
- A treatment group of 125 participants that receives Hydroxychloroquine
- A control group of 125 participants that does not receive Hydroxychloroquine