One study will test an over-the-counter drug on El Paso patients
The battle against COVID-19 isn’t over yet, and Texas Tech University Health Sciences Center El Paso is launching two studies of potential treatments for those suffering from the virus.
TTUHSC El Paso was recently awarded a $1.7 million grant from the National Institutes of Health as part of a multi-center effort to test treatments on COVID-19 patients. Edward Michelson, M.D., professor and chair of the Department of Emergency Medicine at the Foster School of Medicine, is leading the effort at TTUHSC El Paso on two research projects.
The first project, ACTIV-6, is a national trial to evaluate repurposed drugs to see if they can be effective in treating COVID-19. The second project is Dr. Michelson’s own design and focuses on an over-the-counter treatment for nasal allergies. His study will determine if the drug can be used to treat COVID-19 patients.
“Here at TTUHSC El Paso, we’re very involved in researching different aspects of COVID-19,” said Dr. Michelson, who is also medical director of the emergency department at University Medical Center of El Paso. “From diagnostic tests to therapeutic trials, our research will benefit our patients, the local community, and if we’re successful, the world.”
Both trials will be double-blind studies, which means half the patients will receive the drug and the other half will receive a placebo. Neither the physician nor the patient will know which one the patient receives.
With the help of various universities, including TTUHSC El Paso, the ACTIV-6 trial will test several drugs – which have been approved by the FDA for other illnesses – to see if they can be used to treat COVID-19 patients. The study will focus on patients who do not have to be hospitalized. Patients throughout El Paso and southern New Mexico will be eligible to join.
“Once we ID patients who are COVID-19 positive, but well enough to stay home, we’ll contact them, discuss the trial and, if they’re interested, direct them to a website where they can sign consent forms,” Dr. Michelson said.
Patients who agree to participate will receive their medicine by mail from a national pharmacy, which will ensure that neither they nor their physician know if they’ve received the drug or a placebo. They will then report their symptoms over a 14- to 28-day period.
Participating universities will initially test three different drugs. Depending on a drug’s success or failure, it may be dropped from the study or expanded for testing at other sites. As one or more of the drugs is found to have value or not to help they may be dropped and new drugs added. The first three drugs to be studied are ivermectin, fluvoxamine and fluticasone.
Ivermectin, normally used to treat conditions caused by parasitic worms, has been in the news lately, with some people self-medicating with versions of the drug meant for use in animals. However, Dr. Michelson said ivermectin, for human use, will be prescribed in doses based on patient weight. Results from prior trials of ivermectin have produced mixed results. This study should enroll enough patients to finally determine if ivermectin benefits COVID-19 patients.
Fluvoxamine is a drug used in psychiatry that has been shown in small studies to help keep patients with COVID-19 out of the hospital. Fluticasone, is a strong steroid spray inhaled by some patients with asthma. This medication may reduce the lung injury associated with COVID-19 pneumonia.
Each patient who agrees to participate will be assigned to one of the three drugs or a matching placebo. The research team and patient will know which of the three drugs they are assigned, but will not know if the patient is getting the active drug or an identical looking placebo. Prospective randomized clinical trials are the gold standard in medicine to determine if a new treatment is effective.
“All patient encounters will be done by internet and phone, adding another layer of convenience and safety,” Dr. Michelson said. “The patients will receive the medication at their home, and interact with the research team over the phone. No ‘in-person’ visits will be required of them.”
Dr. Michelson hopes to begin enrolling patients in ACTIV-6 trial within the next month. Nationally, the NIH aims to enroll 15,000 patients, but in El Paso the goal is to recruit 400. He hopes to recruit patients from the entire Borderland region, including Las Cruces.
“The fact that El Pasoans have access to treatments that are part of national clinical trials is important,” Dr. Michelson said. “A study like this benefits the community because it gives them a chance to be part of cutting-edge medical research.”
The second trial will test the anti-inflammatory drug cromolyn, an inexpensive generic drug used to treat eye and nasal allergies as well as asthma symptoms. It’s currently available as a nebulizer solution or eye drop, which both require a prescription, or as a nonprescription nasal spray.
Dr. Michelson designed the study because cromolyn reduces inflammation of the lungs, which is how COVID-19 causes serious illness. He’s seen anecdotal evidence at UMC that the nasal spray formulation of cromolyn could be effective for treating COVID-19 patients.
“Cromolyn needs to be tested in a controlled environment,” Dr. Michelson said. “If it turns out to be effective, then it could be used as a home treatment. And because it’s inexpensive, it also would be a best option for developing nations and lower-income areas.”
Dr. Michelson hopes to enroll 60 patients in his cromolyn study. The first 10 will receive the drug and observe its effectiveness to ensure there are no ill side effects. The next 50 patients will be observed under a double-blind trial, with half receiving a placebo.
Dr. Michelson said he’ll target COVID-19 patients admitted to UMC so they do not overlap with the patients in the ACTIV-6 study, who will stay at home. Patients will be treated with cromolyn at the hospital and stay on the medication for about three weeks after leaving the hospital. He will follow up with them four weeks afterward to check on their progress.
“They won’t be the sickest inpatients, but they’ll have evidence of pneumonia from COVID-19 and require supplemental oxygen,” Dr. Michelson said. “This could be helpful in curbing the long-term effects of COVID-19 that we’ve been hearing and reading about.”
If cromolyn is proven effective in the small trial, Dr. Michelson will propose it be added to the list of the repurposed drugs in the ACTIV-6 study. This will allow other medical centers to adapt TTUHSC El Paso’s protocols and recruit more patients nationally.
Dr. Michelson is awaiting approval of the cromolyn study before recruiting patients. The number of COVID-19 cases in El Paso increased throughout July and August. The current surge is most due to the more contagious delta variant of the virus, first detected in India. Most hospitalized patients have not been vaccinated, however fully vaccinated patients may still become infected with the new variant.
“The number of positives is going up again. I think that’s going to translate to seeing more patients in the hospital soon and more people testing positive, particularly among those who are unvaccinated,” Dr. Michelson said. “We’re doing really well with vaccines in El Paso. Our number of hospitalized patients has remained stable, during a time when cases elsewhere in Texas rose to high levels. Although hospitalization rates for COVID-19 locally are not spiking, the daily number of new breakthrough cases of the Delta variant continue to be high.”
TTUHSC El Paso faculty routinely combine their expertise as educators, researchers and physicians to provide quality care to patients and teach the next generation of doctors at the Foster School of Medicine. Faculty members are also attending physicians at Texas Tech Physicians of El Paso, which serves as the medical practice of the Foster School of Medicine and works in affiliation with UMC, one of TTUHSC El Paso’s teaching hospitals. TTP El Paso provides more than $31 million of uncompensated care annually.
TTP El Paso and TTUHSC El Paso serve 108 counties in West Texas that have been historically underserved. It is one of only two health sciences centers designated as Title V Hispanic-Serving Institutions – and the only one on the U.S.-Mexico border.
Fifty percent of 2020-21 students identify as Hispanic. And a majority of the students come from nearby communities and remain in the region and/or return to El Paso to serve the borderland upon graduation and completion of training.
More than 10 years ago, prior to the opening of the Foster School of Medicine, El Paso County’s average number of direct care physicians per 100,000 people was 75% less than the national average. Since then, El Paso County has grown its number of direct care physicians from 844 to 1,325, a 57% increase which is a direct result of having a four-year medical school in the area.