Source: Trial Site News
Treatments for early-onset COVID-19 are in the works at the University of Minnesota as they conduct the nation’s first randomized trial of Ivermectin. Being studied as an outpatient treatment to prevent coronavirus infection, the anti-parasitic has immense potential and is in use in various countries all over the world.
There’s building tension as on the one hand dozens of completed randomized trials’ evidence are all but ignored but major institutions such as the U.S. Food and Drug Administration (FDA) yet on the other hand COVID-19 patient families increasingly take their demands to courts as hospital physicians refuse to treat COVID-19 patients with ivermectin.
Leading the national trial is Dr. Carolyn Bramante, a U internal medicine specialist. Emphasizing the importance of this trial, she says, “Not everybody has access to the vaccine, whereas these medications are existing generics, already FDA-approved, that are available in most pharmacies around the world.” Dr. Bramante continued, “If we find evidence of benefit, [the drugs] could be used immediately anywhere.”
U research already has shown possible benefits of metformin, usually used to manage diabetes, in reducing COVID-19 illness and death in women. But now researchers will compare its effectiveness against ivermectin as well as fluvoxamine, an antidepressant. The U started recruiting up to 1,100 patients 30 or older last week to receive one of the drugs, alone or in combination with metformin, or a non-medicating placebo for comparison.
Effectiveness will primarily be measured by whether patients suffer hypoxia — severe oxygen deficiency.
Bramante said ivermectin has anti-inflammatory benefits that need closer study to see if it inhibits the overreaction to infection by the immune system that can cause severe COVID-19 symptoms.
Funding and Challenges
The Rainwater Charitable Foundation that provided $1 million for the U trial had an interest in studying ivermectin and sponsored a similar trial in Brazil.
The U trial is challenging because clinicians suspect that the drugs work best when provided as early as possible. Recruits must have had positive test results within three days, and the goal is to ship overnight study medications to them so they will start taking them within seven days.
Carolyn Bramante, MD, MPH, is an internist, pediatrician, and obesity medicine doctor who cares for children at the University of Minnesota Health Masonic Children’s Hospital Pediatric Specialty Care Discovery Clinic.