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:
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Conditions: Covid-19
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Age: Between 40 years - 120 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects who are capable and willing to provide informed consent
- Subjects who are outpatients (not currently hospitalized under immediate consideration for hospitalization)
- 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
- 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
- Subjects must be able and willing to comply with the requirements of this study protocol
- 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:
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- Subjects who are currently hospitalized or under immediate consideration for hospitalization
- Subjects currently in shock or with hemodynamic instability
- Subjects who have inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
- Subjects with pre-existent progressive neuromuscular disease
- Subjects with a history of cirrhosis, chronic active hepatitis or severe hepatic disease
- 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
- Subjects currently taking colchicine for other indications
- Subjects with a history of an allergic reaction or significant sensitivity to colchicine
- Subjects undergoing chemotherapy for cancer
- Subjects considered by the investigator, for any reason, to be an unsuitable candidate for the study
- 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.