Remote COVID-19 study adds new ivermectin arm

A clinical trial studying how well drugs already approved for other ailments might work against COVID-19 has opened a new arm to test the antiparasitic drug ivermectin.

The study started last year with the dosage already approved by the Federal Drug Administration, said Leslie Lenert, M.D., director of the Biomedical Informatics Center at the Medical University of South Carolina and the principal investigator for the MUSC study site.

Now, having met its enrollment goal for that dosage, the trial will begin studying a higher dosage while investigators crunch the numbers from the first round.

Called ACTIV-6, the trial is a nationwide study under the umbrella of the National Institutes of Health’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. ACTIV-6 is led by the Duke Clinical Research Institute, with MUSC serving as the study site in South Carolina through collaboration in the National Patient-Centered Clinical Research Network.

 

The trial has multiple “arms” so that it can investigate different drugs at the same time. It began with fluticasone furoate, a corticosteroid often used for asthma or chronic obstructive pulmonary disease that is delivered via inhaler; fluvoxamine, an antidepressant in pill form; and ivermectin at a dosage of 400 mcg/kg for three days.

The fluticasone furoate and the initial ivermectin arms are now closed. The new ivermectin arm will test the drug at 600 mcg/kg for six days.

All of the drugs are being tested in people who have mild to moderate COVID – in other words, people who have tested positive and are symptomatic but haven’t had to be hospitalized.

So far, more than 3,000 people have volunteered for the study, with MUSC enrolling the third-highest number of people among the 87 participating sites across the nation.

Lenert said that, thanks to the remote design of this study, MUSC has been able to include people from across the state. People can sign up through a phone call or online, and the central pharmacies will send the medication and a pulse oximeter to patients’ homes.

To participate:

• 30 years old or older;
• Tested positive for COVID-19 within previous 10 days;
• Experiencing at least two symptoms: fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms and/or new loss of sense of taste or smell.

Call 843-792-4675

Study coordinator Elizabeth Szwast said the patients she’s spoken to have been happy to see studies underway to treat COVID.

“They're excited to collaborate in research, especially folks who may not be in Charleston specifically, but they're in other parts of the state and would like to engage in research for the first time where they haven't had the opportunity to do so previously. That's one of the big things that remote clinical trials have opened a door for,” Szwast said.

An important part of Szwast’s job is educating potential research volunteers about how research works. The study is a randomized double-blind trial. That means that volunteers will be randomly assigned to receive either the study medication or a placebo, and neither the patient nor Szwast or Lenert will know which one the patient is taking.

Doing studies this way removes unconscious bias – the hope or doubt that a doctor can inadvertently convey to the patient, through tone of voice or body language, when the doctor and patient know what the patient has received.

“There are all sorts of human biases that go in with observation of effects, particularly clearing of symptoms in patients,” Lenert said.

In addition, randomization ensures that the group of patients who receive the study medication will be similar to the group that receives the placebo. Otherwise, researchers may subconsciously give the study drug to patients who were less sick and more likely to recover anyway, Lenert said.

“That kind of bias creeps into studies unless there's blinding and randomization,” Lenert said. “Anything less than that isn't really science.”

Unfortunately, early studies of ivermectin haven’t all followed these scientific principles. Some of these studies have since been retracted, but those less-than-scientific studies have been included in meta analyses – analyses of all the existing studies on one subject – and have skewed the results. So far, Lenert said, credible studies haven’t shown a benefit to ivermectin.

The hope is that ACTIV-6, as well as other randomized, blinded studies, can provide solid answers about what works and what doesn’t in the fight against COVID.

That’s important because, although infection numbers are currently dropping in South Carolina, there’s no guarantee that they won’t go up again.

“The next variant is mutating out there, and we need to know what to do,” Lenert said.

South Carolina residents interested in participating in the study can contact Szwast at 843-792-4675. Participants must be 30 years old or older, have tested positive for COVID-19 within the previous 10 days and have at least two COVID symptoms, including fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms and/or new loss of sense of taste or smell.