By: Joslyn Cassano | Published: December 13, 2022
Dushyantha Jayaweera, M.D.
A recent study published in Journal of the American Medical Association (JAMA) shows the drug ivermectin, which is approved for the treatment of parasitic diseases including scabies, is not an effective treatment for mild to moderate COVID-19 symptoms.
In the early days of the pandemic, when medical experts were in an all-out scramble to find treatments for the virus, ivermectin showed the potential to block COVID-19 replication and decrease the inflammatory response, says Dushyantha Jayaweera, M.D., principal investigator for the study and Associate Director and co-investigator of the Miami CTSI.
For this reason, ivermectin as well as other drugs like hydroxychloroquine, were used by some physicians as a stop-gap treatment for COVID-19 symptoms without scientific evidence that they were effective at treating COVID-19. Findings from the study led by Dr. Jayaweera and co-investigator Olveen Carrasquillo, M.D., MPH, do not support the use of ivermectin in outpatients with mild to moderate COVID-19.
The double-blinded, randomized, placebo-controlled platform trial was conducted in the U.S. across a national clinical trials network during a period where Delta and Omicron variants of COVID-19 were prevalent. Researchers wanted to find out if any existing drugs could be used as a treatment.
Olveen Carrasquillo, M.D., MPH
Ivermectin is part of what Dr. Jayaweera and Dr. Carrasquillo call the ACTIV-6 platform, a group of drugs pre-approved for other conditions that are being studied closely to find out if they are effective at combating COVID-19. The research done to this point has shown that three of the six, including ivermectin, are not suitable treatments for the virus.
The ACTIV-6 study adds to a nascent body of research on COVID-19 treatments that will help clarify for physicians and their patients what is effective in treating symptoms of the virus. Publication in JAMA is significant because of the medical journal’s high impact factor, a score assigned to medical publications that indicates how widely circulated the research might be.
In the past, high-impact journals suffered from “publication bias,” favoring studies that showed a positive result or affirm a scientific hypothesis, says Carrasquillo, who is also Miami CTSI Co-Director and MPI.” Several years ago, many high-impact journals realized that was a mistake and that publishing papers showing negative findings are also important to publish.”
The study is also groundbreaking in its implementation, which was adapted to minimize in-person interactions during the pandemic. All medications used in the trial are sent directly to participants, eliminating the inconvenience of going to the pharmacy. There are no blood draws, and no office visits. Dr. Jayaweera hopes that NIH will use this ACTIV-6 platform to study treatment options for patients with lingering COVID-19 symptoms, or “long COVID.”
The ability to successfully conduct a study with minimal contact has implications for the future of research. “In the event of another pandemic, with a platform like this already available, it will be easy to roll things out very quickly,” says Dr. Jayaweera. “It’s an innovative way to do clinical trials.”
The ACTIV-6 study will continue exploring the remaining approved drugs, publishing results as they are determined. “This was another very important study showing not what works, but what doesn’t work,” says Dr. Carrasquillo.
“The most important thing in science is to know what works and what does not without any bias,” says Dr. Jayaweera.
ACTIV-6 is part of the National Institutes of Health-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) and is led by the National Center for Advancing Translational Sciences (NCATS). The Duke Clinical Research Institute serves as the study’s clinical coordinating center, partnering with Vanderbilt University Medical Center as the study’s data coordinating center.
The study is leveraging the infrastructure of PCORnet®, the National Patient-Centered Clinical Research Network, supported by the Patient-Centered Outcomes Research Institute, and the Trial Innovation Network, a collaborative initiative within the NCATS Clinical and Translational Science Awards Program that helps address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies.