EL PASO, Texas (KTSM) – As the controversy surrounding the use of ivermectin to treat COVID-19 heats up across the nation, Texas Tech University Health Sciences Center in El Paso will be conducting a pair of clinical trials to test the efficacy of four different drugs, including ivermectin.
TTUHSC has been awarded $1.7 million by the National Institutes of Health to conduct the clinical trials. Dr. Edward Michelson, who is conducting the trials, felt honored to be selected as one of the sites for the trials.
“Here at Texas Tech and University Medical Center, we are very fortunate to be invited to participate in an NIH-sponsored clinical trial of COVID-19 patients called ACTIV-6.”
The human form of ivermectin, that is already being administered to people to treat conditions caused by parasitic worms, is not to be confused with the animal form of the drug. Michaelson said that their study of the drug will be very precise in terms of dosages administered to patients.
“One of those study drugs is ivermectin, which as you mentioned has been in the news quite a bit. The one we are using will be the human version and we will be adjusting the dose to the person’s body weight, so that’ll be a little different than how people are buying it over the internet – ivermectin for animals – and not being careful about the dose.”
Ivermectin received national attention after people started taking the animal form of the drug to treat COVID-19. The usage of an animal drug prompted the FDA to send out a warning, telling people to stop taking medications made for animals.
According to c19Ivermectin.com, 63 trials involving 625 scientists and nearly 50,000 patients have already been conducted with the human form of the drug, some of which they say, showed positive results. However, Michelson said that more studies need to be conducted.
“The key is numbers. In some cases, you need very large numbers to prove [that the drug is] effective. There has been research and it’s mixed, so I think the NIH wanted once and for all to put that to rest.”
Michelson said it’s gratifying to be able to bring this clinical trial to the Sun City saying, “Patients will be helping themselves but also they’re helping the community and the country at large by participating so we can finally get an answer on whether the drugs help patients with COVID-19.”
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.
The first trial, ACTIV-6, will test ivermectin, along with three other drugs. 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,” 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 knows if they’ve received the drug or a placebo. They will then report their symptoms over a 14- to 28-day period.
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.
“The fact that El Pasoans have access to treatments that are part of national clinical trials is important,” 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.
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,” he 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.”
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.