A new clinical trial seeks to determine whether the common anti-inflammatory medication colchicine can help decrease the progression of disease in people with coronavirus disease 2019 (COVID-19).
Co-led by clinician–researchers at NYU Langone Health and the Montreal Heart Institute Research Centre, the new COLCORONA trial will investigate whether short-term treatment with colchicine reduces the rate of hospitalizations, lung complications, and death related to COVID-19.
“At present, there is no proven treatment for those diagnosed with COVID-19,” says trial investigator Binita Shah, MD, interventional cardiologist, assistant professor in the Department of Medicine, and the study’s principal investigator at NYU Langone. “Our research experience with colchicine suggests that early use of this drug may help dampen inflammation that the body produces in response to the virus and enable patients to recover without being hospitalized.”
Colchicine, the generic name of the medication used in the trial, taken as a pill in its current form, has been used for more than 2,000 years to treat gout and other inflammatory conditions. Dr. Shah’s team previously showed that colchicine dampens the inflammatory response when given before a cardiac injury, and thought to test it in COVID-19 to reduce later complications in adults at risk of developing an “inflammatory storm.”
The trial will enroll, and follow for 30 days, about 6,000 participants who meet the following criteria:
- have a COVID-19 diagnosis (test positive or have classic symptoms of fever, cough, difficulty breathing, or loss of taste and smell) within the past 48 hours
- are 40 years of age or older
- have at least one high-risk criteria, such as diabetes, hypertension, obesity, or asthma
- are not hospitalized for COVID-19
- are willing to take the drug or placebo daily for 30 days
- are willing to participate in two follow-up calls by phone or videoconference
Women who are premenopausal and do not take contraceptives, are pregnant, or are breastfeeding are not eligible.
Participants will be randomized to receive either a colchicine or placebo regimen that involves taking a pill twice daily for 3 days and then once daily for the remaining 27 days. The participants will be contacted by a research nurse on day 15 and day 30 to assess their response to the medication.
“If successful, this medication could be added to treatment protocols quickly across the country and internationally,” says Michael H. Pillinger, MD, professor of medicine and co-principal investigator on the study at NYU Langone. “We are at a critical point in this pandemic where implementing our existing knowledge to find solutions is vital.”
The COLCORONA trial is funded by the Government of Quebec and supported by Pharmascience and CGI. Additional funding is provided by NYU Langone Health.
Physicians with patients with COVID-19 or people with a COVID-19 diagnosis who are interested in participating in the clinical study can call the hotline at any time at 1-877-536-6837 and visit the COLCORONA trial website.