Controversial Ivermectin Added to University of Minnesota COVID-19 Drug Trial

Controversial Ivermectin Added to University of Minnesota COVID-19 Drug Trial

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. And proven medications against COVID-19 have been lacking, especially those that could be used on an outpatient basis to prevent severe illness.  But 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.”

Study Details

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.

Lead Research/Investigator

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.

Responses

  1. UMN is CIDRAP who don’t have courage to say one thing against Big Pharma, your sponsors. I trusted MTOsterholm and feel duped. All lovey dovey with his grandkids. Many died while he ignored IVERMECTIN. Pushes Vax. I won’t. So your trial tainted. Too little. Too late.

  2. • No need to make claims of “nation’s first trial.” Why? Because you may be make to look foolish if someone else has started enrollment or received IRB approval before the alleged “nation’s first.”
    • Will it get started before this one at Duke and Vanderbilt? https://clinicaltrials.gov/ct2/show/NCT04885530
    • Is this a trial to “prevent coronavirus infection” or to prevent progression to hypoxia (severe Covid-19)?

  3. The only real issue is that IVERMECTIN has had its fair share of (deliberately?) botched trials, potentially confounding additional treatments and protocols added instead of a truly gold-standard placebo-controlled randomised study, where it’s either Ivermectin or Nothing (but placebo). Please, can someone get this done already? One primary outcome for or against. I would suggest the FLCCC I-mask+ form the basis of the trial and the outcomes published. University of Minnesota?

  4. One potential trial for hospitalized patients would be a head-to-head trial between Ivermectin and Ramdesivir. Arm 1 gets real Ivermectin and fake Ramdesivir, while arm 2 gets fake Ivermectin and real Ramdesivir. Let’s see which one gets knocked down.

  5. I hope everyone who thinks that this study is malformed will start complaining to the lead researcher immediately – rather than waiting until the results are reported.

      1. Also 1100 patients is absurdly small. Doubt it has the power to prove anything. The available data from randomized trials covers well over 5000 patients already.
        The NIH Activ trial plans to enroll 15,000.