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A new international trial will examine whether a common anti-inflammatory drug known as colchicine could ward off COVID-19 symptoms and potentially prevent the need for hospitalization for some patients.
The study, which has the University of California-San Francisco and New York University School of Medicine as its first two clinical test sites, 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.
“This is one of the very few COVID-19 trials designed specifically for patients who have not yet been hospitalized,” said Priscilla Hsue, a professor of medicine at UCSF and principal investigator for the UCSF study site, in a statement. “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.”
Colchicine, which is inexpensive and widely available, has been prescribed for many years to treat gout by reducing joint pain and swelling, according to researchers.
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, emeritus professor of cardiology at UCSF and assistant principal investigator for the UCSF study site, in a statement.
In order to allow for patients to participate while still observing isolation protocols, the research team has proposed a "no contact" study. Patients can apply for the trial by phone and if they're eligible, they will sign informed consent documents accessible via cell phone or computer. The study medication would be sent to their home by courier within a few hours of enrollment. Follow-ups would happen by phone or video at the 15- and 30-day mark.
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“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.”
More information on the drug trial can be found here.