Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
Condition: Corona Virus Infection
MeSH terms: Coronavirus Infections
Intervention: Colchicine; Placebo oral tablet
Intervention description: Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.; Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
Intervention MeSH terms: Colchicine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a randomized, double-blind, placebo-controlled, multi-center study. Following signature of the informed consent form, approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo (1:1 allocation ratio) for 30 days. Follow-up phone or video assessments will occur at 15 and 30 days following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 4506.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This is a phase 3, randomized, double-blind, placebo-controlled multicenter study to evaluate
      the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and
      have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and
      no exclusion criteria will be randomized to receive either colchicine or placebo tablets for
      30 days.
    

Eligibility criteria:

        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.