UC San Francisco is recruiting more than 2,500 adults who are newly diagnosed with COVID-19 for a nationwide clinical trial to assess whether the common antibiotic azithromycin can reduce hospitalization stays and death caused by the SARS-CoV-2 virus.
Using a contactless approach, researchers will ship the study drug directly to patients’ homes and conduct all recruitment and follow-up visits remotely. Participants will receive either a single oral dose of azithromycin or a placebo, with a 2:1 chance of receiving the antibiotic.
“Identifying early-stage therapeutics has the potential to limit disease progression, hospitalizations and deaths, so we are hoping to recruit patients early in their illness, before they require hospitalization,” said principal investigator Catherine Oldenburg, ScD, MPH, assistant professor in the Francis I. Proctor Foundation at UCSF, which is leading the trial in collaboration with the Bill & Melinda Gates Foundation, Pfizer Inc. and Stanford University.
“Macrolides such as azithromycin have long been hypothesized to have therapeutic benefits on viral infections, either via their anti-inflammatory or off-target effects on viral replication,” Oldenburg said. “If found to be effective in patients with mild COVID-19, this could improve patient outcomes and reduce the strain on our health care system.”
The ACTION trial – for Azithromycin for COVID-19 Treatment, Investigating Outpatients Nationwide – stems from work by the Proctor Foundation in Niger, where it has overseen long-standing programs to provide antibiotics like azithromycin to communities to prevent blindness from an infectious disease known as trachoma. In a large, randomized trial, researchers found that children in communities receiving azithromycin biannually for trachoma also had lower levels of non-SARS coronavirus in their throats, compared to children who received a placebo.
Azithromycin is an inexpensive, widely used antibiotic with a good safety profile that also has been shown in the lab to have activity against RNA viruses such as SARS-CoV-2.
The trial is designed to be scalable to adapt to changes in the pandemic, probability of hospitalization, and challenges with recruitment or enrollment. For more information, visit proctor.ucsf.edu/action-trial, email [email protected] or call 415-326-3761.
About the Proctor Foundation: The Francis I. Proctor Foundation for Research in Ophthalmology is an internationally renowned, privately endowed organized research unit at the University of California, San Francisco. The Foundation is dedicated to research and training in infectious and inflammatory ocular diseases, and the application of this research to the prevention of blindness worldwide. It is recognized as the preeminent center in the world for this discipline.
About UCSF: The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. UCSF Health, which serves as UCSF’s primary academic medical center, includes top-ranked specialty hospitals and other clinical programs, and has affiliations throughout the Bay Area.