Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19

• Status: Completed
• Trial end date: 2021-07-09
• Target enrollment: 0
• Participant gender: All

Summary

COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan failure and elevated mortality. Oral Colchicine exhibits high anti-inflammatory capacity attributed to the inhibition of microtubules polymerization, inflammasome and production of IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. The investigators present a randomized, controlled, open-labeled, and pragmatic clinical trial to study the treatment effect of Colchicine in COVID-19 patients requiring hospitalization, but no intensive care yet. Colchicine will be started within the first 48 hours and continue for 14 days using a descending dose. The benefits will be studied in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary end-points. In the case of positive results, the clinical impact would be relevant given that this oral medication is affordable and widely accessible which would help to prevent the inflammatory complications associated with COVID-19.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ayub Teaching Hospital
• Collaborator: Universidad de Murcia
• Treatments: Colchicine

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.