Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

Inclusion Criteria

• •1. Males and females, at least 40 years of age, capable and willing to provide informed consent;
• •2. Patient must have received a diagnosis of COVID-19 infection within the last 24 hours;
• •3. Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization);
• •4. Patient must possess at least one of the following high-risk criteria: 70 years or more of age, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count;
• •5. Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;
• •6. Patient must be able and willing to comply with the requirements of this study protocol.