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.

Exclusion Criteria:

1. Patient currently hospitalized or under immediate consideration for hospitalization;

2. Patient currently in shock or with hemodynamic instability;

3. Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis),
chronic diarrhea or malabsorption;

4. Patient with pre-existent progressive neuromuscular disease;

5. Estimated Glomerular filtration rate (eGFR), using the MDRD equation for all subjects
being considered for enrollment, with a cut-off of < 30 mL/m in/1.73m2;

6. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic
disease;

7. Female patient who is pregnant, or breast-feeding or is considering becoming pregnant
during the study or for 6 months after the last dose of study medication;

8. Patient currently taking colchicine for other indications (mainly chronic indications
represented by Familial Mediterranean Fever or gout);

9. Patient with a history of an allergic reaction or significant sensitivity to
colchicine;

10. Patient undergoing chemotherapy for cancer;

11. Patient is considered by the investigator, for any reason, to be an unsuitable
candidate for the study.