First Trial in US Exploring Ivermectin Against COVID-19 Begins

May 12, 2020 Updated: May 12, 2020

A new clinical trial recently started testing three drugs against COVID-19, along with the widely used hydroxychloroquine.

Scientists at the University of Kentucky’s College of Medicine said they’ll investigate the effectiveness of azithromycin, ivermectin, and camostat mesylate—drugs that could inhibit the replication of SARS-CoV-2, the CCP virus.

The trial is the first in the United States to examine ivermectin, a medicine used to treat parasites, in humans with COVID-19. Ivermectin killed COVID-19 in the lab, researchers said last month.

Azithromycin is a common antibiotic, and camostat mesylate is an enzyme inhibitor.

The three drugs will be tested either as standalone therapies or in combination with hydroxychloroquine, a drug traditionally used against malaria that’s been widely deployed in hospitals to treat COVID-19 patients.

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An arrangement of hydroxychloroquine pills in Las Vegas on April 6, 2020. (John Locher/AP Photo)

Researchers said the trial has a “pick-the-winner” design that will let them quickly understand which potential therapies appear to be effective and guide patients to those treatments.

“While there is no standard treatment for COVID-19, this trial gives us the ability to test multiple therapies rapidly in order to identify the most promising agents,” Dr. Susanne Arnold, a medical oncologist who is co-leading the trial, said in a statement. “This rapid assessment means that the trial can quickly include and test new therapies as it identifies ones that are not effective.”

The possible treatments will be tested on patients at home and in hospitals who have confirmed cases of COVID-19 but have not developed severe symptoms.

Patients must have at least one high-risk condition, such as hypertension, diabetes, or cancer, or be 51 or older.

“The goal is to prevent patients from getting severe cases of the disease that would require hospitalization or put them in the ICU or on a ventilator,” Dr. Zachary Porterfield, an infectious disease expert who is co-leading the study, said in a statement.

“No proven therapies have been demonstrated to prevent progression of COVID-19 to severe illness. This is a critical unmet need for high-risk individuals that would also reduce the strain on our health care system.”

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Transmission electron micrograph of the CCP virus isolated from a patient, published on March 10, 2020. (NIAID)

Once researchers identify which treatments appear to be effective against the illness, they plan to scale up a larger, more traditional placebo-control clinical trial.

Patients who enroll in the trial will be randomly assigned to receive one of four possible treatments: hydroxychloroquine alone; hydroxychloroquine with azithromycin; hydroxychloroquine and ivermectin; or camostat mesylate.

According to the trial listing, 240 participants will enroll. The study is expected to be completed in May 2021.

Patients receiving hydroxychloroquine will get 600 milligrams per day for two weeks. Patients getting azithromycin will receive 500 milligrams on day one, and 250 milligrams for the next four days. Patients receiving ivermectin will receive 12 milligrams for two days if they weigh less than 75 kilograms; otherwise, they’ll receive 15 milligrams for two days.

Patients in the fourth group will receive 600 milligrams of camostat mesylate per day.

The primary outcome measure is the proportion of patients experiencing clinical deterioration, such as death. Researchers will be measuring how many patients come to require admission to intensive care units, assistance breathing from ventilators, or suffer organ failure.

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