These medications have proven to be effective, but they all have to be administered intravenously in a hospital or comparable medical facility. “While we’re doing a good job with treating hospitalized patients with severe disease, we don’t currently have an approved medication that can be self-administered to ease symptoms of people suffering from mild disease at home, and reduce the chance of their needing hospitalization,” said National Institutes of Health (NIH) director Francis S. Collins, MD, in a statement on April 19, 2021. To address the needs of this group, the NIH has embarked on new trials involving volunteers diagnosed with mild-to-moderate COVID-19. While these patients are recovering at home, they will participate in studies aimed at evaluating the effectiveness of existing prescription and over-the-counter medications. The first trial volunteer enrolled on June 23. Called ACTIV-6, the new investigation is part of a project called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), designed to prioritize and speed development of the most promising possibilities. “ACTIV-6 will evaluate whether certain drugs showing promise in small trials can pass the rigor of a larger trial,” said Dr. Collins. RELATED: Coronavirus Alert: The Latest News, Data, and Expert Insight on the COVID-19 Pandemic
Why Is It Important To Find Treatments for Milder Forms of COVID-19?
Principal ACTIV-6 investigator Susanna Naggie, MD, an associate professor of medicine and vice dean of clinical research at Duke University’s Clinical Research Institute in Durham, North Carolina, stresses that identifying drugs that people can safely take by themselves at home when their first symptoms appear can help relieve burdens on the healthcare system. “The goal is to find treatments that will prevent patients from progressing to a level of disease that may be life-threatening and require hospitalization,” says Dr. Naggie. She envisions a future where people may fight COVID-19 like the flu, taking medication at home on a par with the antiviral drug Tamiflu — to ease symptoms, speed recovery, and get back to work or school more quickly. At-home therapies for people with mild-to-moderate COVID-19 may also help them avoid “long-hauler” side effects. As Johns Hopkins Medicine details, many people who have had only mild cases of COVID-19 experience medical issues for weeks or months afterwards, such as fatigue, body aches, joint pain, shortness of breath when exercising, difficulties sleeping, and headaches. Although Naggie was not at liberty to divulge all the medications that will be investigated, she confirmed these drugs are commonly available and already approved to treat other ailments — a factor that could help speed their authorization for use against COVID-19. A report published April 4, 2021, in the Washington Post suggested that treatments that may be evaluated include fluvoxamine, a decades-old antidepressant, and famotidine, the generic name for the heartburn medicine Pepcid. RELATED: COVID-19 Vaccines and Treatments: Where We Stand Now
Can the Anti-Parasite Drug Ivermectin Fight COVID-19?
The first drug in line for investigation under the ACTIV-6 program is ivermectin (Stromectol). Physicians commonly prescribe ivermectin tablets to treat two conditions caused by parasitic worms, intestinal strongyloidiasis and onchocerciasis (river blindness). In a study published in February 2021 in the International Journal of Infectious Diseases, lab tests showed ivermectin to have antiviral properties, and a few small pilot studies have demonstrated that, for some patients with mild COVID-19, the drug can reduce viral load and the duration of symptoms when administered early. Yet a randomized clinical trial involving almost 500 patients with mild COVID-19, published in March 2021 in JAMA, found that ivermectin did not significantly speed recovery time. The researchers noted that larger trials may be needed. Lack of evidence has not stopped people with COVID-19 from deciding to medicate themselves with ivermectin, some opting for pills formulated to prevent heart worm disease and parasites in animals. The U.S. Food and Drug Administration (FDA) has received multiple reports of patients with COVID-19 requiring medical support and hospitalization after taking ivermectin intended for horses.
How the Ivermectin Trial Will Work
When taken for approved uses and as directed by a medical professional, ivermectin has a long safety record. “The safety profile was a critical part of how we were able to get this study off the ground and get the FDA to support it,” says Naggie. The trial is intended to be conducted remotely, with no in-person visits, unless the study team feels such a check-in becomes necessary. Trial volunteers are required to have confirmation of a positive test for COVID-19. Researchers will assign them to a three-day regimen of either ivermectin or placebo, then will follow them daily via a portal accessible by smartphone, computer, or tablet. All study participants receive an oxygen monitor. If a volunteer reports low oxygen levels, the study team will follow up immediately to determine whether that person needs medical care. “We’ve designed the trial so it does not carry a heavy burden on participants or the healthcare system,” says Naggie. “We hope that it’s successful and can really help us understand how to conduct other clinical trials virtually.” The NIH expects that allowing people to participate in the study from home will prove to be an incentive to get more volunteers to sign up, as will the short time commitment. RELATED: A Consumer’s Guide to Clinical Trials
There’s Urgency to Get This Research Done
ACTIV-6 is at the very beginning stages of enrolling volunteers. Researchers are looking to enlist about 10,000 in total as they examine other drugs over the next 18 months or so. Naggie anticipates having some data from these trials by the end of the year. She stresses that although coronavirus numbers in the United States are improving due in large part to the advent of highly effective vaccines, there’s urgency to get this research done. “I think there’s a lot of concern that we may see surges again in the fall, particularly in parts of the country where vaccine rates are low,” says Naggie. “So we want to move as fast as we can.” Trial participants not only have the potential to help themselves, but their family, friends, neighbors, and others from around the world who are fighting COVID-19, according to Naggie. “I would just encourage people who get tested and find they’re positive to reach out, and they can talk to someone to get a better feel for the study,” she says. Anyone interested in learning more about how they can participate in ACTIV-6 or the other ACTIV trials can contact the U.S. Department of Health and Human Services through the CombatCovid website or by calling 877-414-8106.
