EL PASO, Texas (KTSM) – As controversy surrounding the use of ivermectin to treat COVID-19 intensifies across the country, the Texas Tech University Health Sciences Center in El Paso will conduct a pair of trials clinics to test the effectiveness of four different drugs, including ivermectin.
TTUHSC received $ 1.7 million from the National Institutes of Health to conduct the clinical trials. Dr Edward Michelson, who is leading the trials, felt honored to be chosen as one of the trial sites.
“Here at Texas Tech and University Medical Center, we are very fortunate to be invited to participate in an NIH-sponsored clinical trial in COVID-19 patients called ACTIV-6.”
The human form of ivermectin, which is already given to people to treat conditions caused by parasitic worms, should not be confused with the animal form of the drug. Michaelson said their study of the drug will be very specific in terms of the doses given to patients.
“One of those drugs in the study is ivermectin, which, as you mentioned, has been in the news a lot. The one we will be using will be the human version and we will adjust the dose to the person’s body weight, so it will be a little different from how people buy it on the internet – ivermectin for animals – and without paying attention to the dose.
Ivermectin gained national attention after people started taking the animal form of the drug to treat COVID-19. The use of an animal drug prompted the FDA to issue a warning, telling people to stop taking drugs designed 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 have shown positive results. However, Michelson said more studies need to be done.
“The key is the numbers. In some cases you need very large numbers to prove [that the drug is] effective. There’s been some research and it’s mixed, so I think the NIH wanted to put that aside once and for all.
Michelson said it was gratifying to be able to bring this clinical trial to Sun City saying, “Patients will help themselves, but they will also help the community and the country as a whole by participating so that we can finally get an answer on whether the drugs help patients with COVID-19. “
The two trials will be double-blind studies, meaning that half of the patients will receive the drug and the other half will receive a placebo. Neither the doctor nor the patient will know which patient is receiving.
The first trial, ACTIV-6, will test ivermectin, along with three other drugs. The study will focus on patients who do not need to be hospitalized. Patients from El Paso and southern New Mexico will be eligible.
“Once we identify the patients who are COVID-19 positive but well enough to stay at home, we will contact them, discuss the trial and, if they are interested, direct them to a website where they can. sign consent forms, ”Michelson said. noted.
Patients who agree to participate will receive their medicine by mail from a national pharmacy, which will ensure that neither they nor their doctor know whether they have received the medicine or a placebo. They will then report their symptoms over a period of 14 to 28 days.
Michelson hopes to start enrolling patients in the ACTIV-6 trial within the next month. Nationally, the NIH is aiming to enroll 15,000 patients, but in El Paso, the goal is to enroll 400.
“It is important that El Pasoans have access to treatments that are part of national clinical trials,” 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 cromolyn, an anti-inflammatory drug, an inexpensive generic drug used to treat eye and nasal allergies as well as asthma symptoms. It is currently available as a nebulizer solution or eye drops, both of which require a prescription, or as a non-prescription nasal spray.
Michelson designed the study because cromolyn reduces inflammation in the lungs, which is how COVID-19 causes serious illness. He saw anecdotal evidence at UMC that the nasal spray formulation of cromolyne could be effective in treating COVID-19 patients.
“Cromolyn must 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 cheap, it would also be a better option for developing countries and low income areas.
Michelson hopes to enroll 60 patients in his cromolyn study. The first 10 will receive the drug and observe its effectiveness to make sure there are no bad side effects. The next 50 patients will be seen in a double-blind trial, with half receiving a placebo.