Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT04416334
Eligibility Criteria:
Inclusion Criteria:
1. Patients of both sexes who are at least 60 years old.
2. Diagnosis of COVID-19 infection in the last 72 hours and confirmed by PCR
3. Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences
4. The patient must possess at least two of the following high-risk criteria
1. 60 years of age or older AND
2. Any of the following: Diabetes mellitus, high blood pressure, known pulmonary disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia, pancytopenia, or the existence of simultaneous neutrophilia and lymphopenia
5. The patient must be able and willing to comply with the requirements of this study protocol.
Exclusion Criteria:
1. Hospitalized patient or under immediate consideration of doing so
2. Patient taking colchicine for other indications
3. Patient with history of allergic reaction or sensitivity to colchicine
4. Patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or malabsorption
5. Patient with pre-existing progressive neuromuscular disease
6. Patient with kidney damage and estimated glomerular filtrate rate \<30 ml/m at 1732
7. Patient undergoing chemotherapy for cancer, including haematological malignancies.
8. Patients being treated with CYP3A4 and/or glycoprotein inhibitor drugs
9. Immunosuppressive treatment
10. History of cirrhosis, chronic active hepatitis, severe chronic disease defined by GOT or GPT values exceeding 3 times the upper limit of normal.
11. If the investigator considers it, for any reason, to be an inadequate candidate.
12. Patient and/or legal representative will not have signed the informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04416334
Study Brief:
Protocol Section:
NCT04416334