COLCHICINE CORONAVIRUS SARS-CoV2 TRIAL (COLCORONA)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Covid-19
  • Age: Between 40 years - 120 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are capable and willing to provide informed consent
    2. Subjects who are outpatients (not currently hospitalized under immediate consideration for hospitalization)
    3. Subjects must possess at least one of the following high-risk criteria: 70 years or more of age, 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
    4. Female subjects who are not of childbearing potential or are of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method throughout the study and for 30 days after the study completion
    5. Subjects must be able and willing to comply with the requirements of this study protocol
    6. Outpatient with confirmed diagnosis of COVID-19 within 36 hours of result notification. Subjects should have a Positive COVID-19 test (PCR) OR have sudden onset of the following symptoms without an obvious alternative cause:
      • Fever (> 38 degrees C = 100.4 degrees F) and cough
      • OR
      • Fever (> 38 degrees C= 100.4 degrees F) or cough with = 1 of the following symptoms:
        • shortness of breath
        • extreme fatigue
        • muscle or joint pains
        • sudden anosmia without nasal obstruction, with or without agueusia

You may not be eligible for this study if the following are true:

    1. Subjects who are currently hospitalized or under immediate consideration for hospitalization
    2. Subjects currently in shock or with hemodynamic instability
    3. Subjects who have inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
    4. Subjects with pre-existent progressive neuromuscular disease
    5. Subjects with a history of cirrhosis, chronic active hepatitis or severe hepatic disease
    6. Female subjects who are pregnant, or breast-feeding or are considering becoming pregnant during the study or for 6 months after the last dose of study medication
    7. Subjects currently taking colchicine for other indications
    8. Subjects with a history of an allergic reaction or significant sensitivity to colchicine
    9. Subjects undergoing chemotherapy for cancer
    10. Subjects considered by the investigator, for any reason, to be an unsuitable candidate for the study
    11. Estimate 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



If you are registered as a volunteer, please log in to contact the study team/express interest in this study.