People infected with COVID-19, who are eligible to partake in a study, could be given Ivermectin to treat the infectious disease.
Texas Tech University Health Sciences Center El Paso is part of a nationwide study to research potential treatments for those suffering from the virus.
TTUHSC El Paso Part announced it will conduct two studies: 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. Edward Michelson’s project on an over-the-counter treatment for nasal allergies.
Michelson’s study will determine if the drug can be used to treat COVID-19 patients.
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.
Michelson is leading the effort at TTUHSC El Paso on the two research projects.
During the trial, 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,” 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,” 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.”
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. Michelson 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,” Michelson said. “A study like this benefits the community because it gives them a chance to be part of cutting-edge medical research.”