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A new international trial will examine whether a common anti-inflammatory drug known as colchicine could ward off the symptoms of COVID-19 and potentially prevent the need for hospitalization for some patients.
The study, which has the University of California at San Francisco and the Faculty of Medicine of New York University as its first two clinical trial sites, aims to enroll 6,000 newly diagnosed patients over the age of 40 and with at least one additional risk factor for COVID-19 serious complications, such as chronic lung disease, heart disease or age over 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, UCSF professor of medicine and principal investigator for the d UCSF study, in a press release. “We believe that early treatment, before the onset of severe symptoms requiring hospitalization, may offer the best chance of improving 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 the researchers.
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The life-threatening complications of COVID19 can be caused by a so-called cytokine storm, in which the inflammatory response of the immune system overwhelms the organs of the body.
“The COLCORONA study hypothesizes, based on preliminary evidence, that the anti-inflammatory effects of colchicine can prevent this cytokine storm and limit damage to other organs such as the heart, brain and kidneys . Children were relatively unaffected by the Spanish flu epidemic in 1918, and we are seeing the same pattern with COVID-19. This may be due to the fact that the 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 patients to participate while respecting isolation protocols, the research team proposed a “contactless” study. Patients can request the test by phone and if they are eligible, they will sign informed consent documents accessible via a cell phone or computer. The study drug would be sent to their homes by courier within a few hours of enrollment. Follow-ups would be done by phone or video after 15 and 30 days.
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“The design of the contactless study allows patients to stay at home,” said Hsue. “This intervention with an inexpensive and readily available drug can be easily extended to reach individuals globally, if it proves effective. “
For more information on the drug test, click here.