Trial of outpatient drugs for COVID-19 opens to all South Carolinians

Editor's Note: Dr. Rami Zebian is no longer involved in the ACTIV-6 trial. For information about participating in this trial, contact study coordinator Elizabeth Szwast at hinsone@musc.edu or  843-792-4675.

A new clinical trial open to all South Carolinians is testing three common drugs in the fight against COVID-19. 

“It is such a cool trial. You don’t even have to go to a doctor’s office to be part of this trial. It’s completely remote,” said Leslie Lenert, M.D., director of the Biomedical Informatics Center at the Medical University of South Carolina. That means that people don’t have to live within easy access of an MUSC hospital to participate and potentially benefit from the treatment.

“It’s just perfect for our new MUSC sites and the rural populations. It’s really great to be able to offer these kinds of things,” Lenert said.

Called ACTIV-6, the trial is led by the Duke Clinical Research Institute in North Carolina and covers several states. Lenert is the principal investigator for MUSC. Rami Zebian, M.D., chief medical officer of MUSC Health-Florence Division, serves as clinical co-investigator for the Florence and Marion hospitals. Zebian said he’s thrilled to be able to offer clinical trials to people in the Pee Dee region.

“Currently, there are limited treatment options that are FDA-approved that doctors can offer to patients with COVID-19 who aren’t sick enough to be in the hospital. Monoclonal antibody infusions are available on an outpatient basis for high-risk patients, but mainly patients are told to stay home, rest, drink plenty of fluids and possibly take acetaminophen or ibuprofen for fever. This trial will allow us to determine possible treatment options for patients to benefit from. We have seen a lot of misinformation out there, and unfortunately, some patients have received non-FDA approved medications outside of a clinical trial. That is not a safe practice, and we have seen many reports of toxicity – and we have many unanswered questions.

“I strongly believe that a clinical trial helps us answer those questions and offers possible treatment options in a safe and controlled manner,” Zebian said.

The trial is testing three drugs that could help people with mild to moderate illness who are recovering at home. The study drugs are fluticasone, a corticosteroid often used for asthma or chronic obstructive pulmonary disease that is delivered via inhaler; fluvoxamine, an antidepressant in pill form; and ivermectin, a drug that is used to treat parasitic infections and that has been in the news quite a lot lately.

“Everybody's heard about ivermectin,” said Elizabeth Szwast, the study coordinator. “It’s a really hot topic right now, and this is a safe environment to see whether it’s effective to reduce COVID-19 symptoms.”

Lenert said that volunteering for the study can help to settle the question of ivermectin’s effectiveness.

“If you believe in it – get into a clinical trial. If you don’t believe in it – get into a clinical trial. Let’s get the answer out, and let’s stop fighting each other over it,” he said.

“It's really a very flexible tool to allow science to reign.”

Dr. Leslie Lenert

People interested in the trial will have the option to choose which study arm they would like to be a part of. For example, someone could say she is willing to participate in any of the three study arms – fluticasone, fluvoxamine or ivermectin. She would then be randomly assigned to one of the three arms and from there randomly assigned to receive either the study drug or a placebo. Or, someone could say he wants to only participate in the fluvoxamine arm because he’s read about good results the drug has had in small trials. He would be assigned to the fluvoxamine group and from there would be randomly assigned to receive either the drug or a placebo. 

Once someone is accepted into the trial, the central pharmacies mail the study drug and a pulse oximeter to the patient. The patient takes the study medication as directed, fills out daily surveys online and responds to phone call questionnaires from Szwast on days 14 and 28. After 90 days, the participants each receive a $100 Amazon gift card as a thank-you gesture for time and participation in the clinical trial.

The ACTIV-6 trial is part of a larger public-private partnership that is investigating treatments for COVID-19 from a variety of angles, including immune modulators, monoclonal antibodies, anticoagulants, in-patient treatments and repurposed drugs for outpatient treatment.

ACTIV-6 is set up as a platform trial, allowing it to adapt as evidence develops and add or remove drugs. The trial leaders could easily add a fourth or fifth study drug, Lenert explained, if the public-private scientific advisory board coordinated by the Foundation for the National Institutes of Health determines other promising candidates.

“It’s really a very flexible tool to allow science to reign,” he said.

MUSC’s participation came about because of its participation in the National Patient-Centered Clinical Research Network (PCORnet) and the Stakeholder, Technology, and Research Clinical Research Network (STAR CRN) which provides a pathway for researchers to conduct multisite trials. Lenert urged MUSC faculty members who are conducting research, regardless of whether it is COVID-19 related, to look into using PCORnet as a way to obtain large amounts of data and collaborate with MUSC PCORnet partners at the Mayo Clinic, Vanderbilt University, Duke Health, the University of North Carolina at Chapel Hill, Wake Forest Baptist Health, Meharry Medical College and beyond.

Anyone interested in participating in the ACTIV-6 study can call 843-792-4675 or visit activ6study.org.

To be eligible for the study, patients must:

• Be over 30 years old. 
• Have had a positive COVID-19 test within the past 10 days. 
• Be experiencing at least two of the following symptoms: feeling tired, trouble breathing, fever, cough, upset stomach, vomiting, diarrhea, body aches or chills, headache, sore throat, stuffy nose or new loss of taste or smell.