UC San Francisco is recruiting newly diagnosed COVID-19 patients for a large global clinical trial testing whether the common anti-inflammatory drug colchicine can reduce hospitalization and death caused by the illness.
Using an innovative new “contactless” approach, researchers will ship the study drug directly to patients’ homes within 48 hours of diagnosis, and will conduct all recruitment and follow-up visits remotely.
“This is one of the very few COVID-19 trials designed specifically for patients who have not yet been hospitalized,” said Priscilla Hsue, MD, a professor of medicine at UCSF and principal investigator for the UCSF study site. “We suspect that early treatment, before the onset of severe symptoms requiring hospitalization, may provide the best chance to improve outcomes. By the time extensive lung damage has developed, it may be too late to intervene successfully.”
UCSF and New York University School of Medicine will serve as the first two U.S. clinical sites for the Colchicine Coronavirus SARS-CoV-2 Trial, known as the COLCORONA study, which is led by the Montreal Heart Institute. The study also has several sites in Canada and additional sites are being developed in Europe.
Life-threatening complications of COVID19 can be caused by a so-called cytokine storm, in which the immune system’s inflammatory response overwhelms the body’s organs.
“The COLCORONA study hypothesizes, based on preliminary evidence, that the anti-inflammatory effects of colchicine may prevent this cytokine storm, and limit the damage to other organs such as the heart, brain and kidney. Children were relatively spared by the Spanish flu epidemic in 1918, and we see the same pattern with COVID-19. This may be because cytokine storm is less likely in children,” said David Waters, MD, emeritus professor of cardiology at UCSF and assistant principal investigator for the UCSF study site. Waters is a former a director of the Montreal Heart Institute Research Centre and former chief of cardiology at Zuckerberg San Francisco General Hospital and Trauma Center.
Colchicine is an inexpensive, safe, and widely available anti-inflammatory medication that has been prescribed for millennia to treat gout by reducing joint pain and swelling. Poultices of autumn crocus flowers, from which colchicine was originally derived, were used to treat gout as early as 1500 BCE. Recently a study published in the New England Journal of Medicine found that low doses of the drug safely reduced the risk of recurrent cardiac events, particularly in people who have already survived a heart attack.
“This is an important trial that may provide definitive answer as to benefits of inflammation reduction for prevention of COVID19-related complications," said Jean-Claude Tardif, MD, director of the Montreal Heart Institute Research Centre, and the lead investigator of COLCORONA study, in a video describing the study. Tardif also led the cardiac study of colchicine cited above.
The randomized double-blind placebo-controlled trial aims to enroll 6,000 newly diagnosed patients over age 40 and with at least one additional risk factor for serious COVID-19 complications, such as chronic pulmonary disease, heart disease, or age greater than 70 years. Thirty days after enrollment, the study will assess whether colchicine treatment reduces rates of hospitalization or death from the disease.
To allow newly diagnosed patients to participate while isolated within their homes and avoid the need to be seen in the clinic, the researchers developed an unusual “no-contact” study design. Patients will apply for the trial by phone and if eligible (including living within the geographic region of the study site), will sign digital informed consent documents accessible via cell phone or computer. They will receive the study medication at home by courier within four hours of enrollment. Follow-up will be done by phone or video at 15 and 30 days.
“The contactless study design allows patients to remain at home,” said Hsue. “This intervention with an inexpensive, readily available drug can be easily scaled up to reach individuals on a global level, should it prove effective.”
The trial is described in more detail at https://www.smartpatients.com/trials/NCT04322682. Patients can learn about the trial and if eligible, enroll by calling (877) 536-6837.
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.