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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04350320
Eligibility Criteria:
Inclusion Criteria:
1. SARS-CoV-2 infection confirmed by PCR.
2. Admitted in the hospital in the previous 48 hours, with clinical status 3, 4 or 5 of WHO classification.
3. Age above 18 years old.
4. Informed written consent.
Exclusion Criteria:
1. Invasive mechanical ventilation needed.
2. Established limitation of the therapeutic effort
3. Inflammatory bowel disease (IBD: Chron Syndrome or Ulcerative colitis), chronic diarrhea or malabsorption.
4. Previous neuromuscular disease.
5. Other disease with an estimated vital prognosis under 1 year.
6. Severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2)
7. Medical records of cirrhosis, active chronic hepatitis or severe hepatic disease defined by GOT or GPT levels three times above the normal upper limit.
8. Patients with previous colchicine treatment for other diseases (mainly chronic prescriptions for familial Mediterranean fever or gout). Clearance period will not be required for patients treated with colchicine who stopped the treatment before the randomization.
9. Patients with history of allergic reaction or significant sensitivity to colchicine.
10. Treatment with immunosuppressive agents, corticoids or interleukine-1 antagonists for 6 months before inclusion.
11. Pregnant or breastfeeding female, confirmed by a positive result in the human chorionic gonadotropin (hCG) test.
12. Fertile woman, or post-menopausal during less than one year and non-surgically sterilized. Women of fertile age may be included if using at least one contraceptive method and preferably two complementary contraceptive methods.
13. Use of other investigational drugs in the moment of inclusion, or during 30 days previous to inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04350320
Study Brief:
Protocol Section:
NCT04350320