Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with two branches. Patients who meet all the inclusion criteria and none of the exclusion criteria will be randomized 1: 1 to be included in one of the following groups:

• Experimental group: colchicine for 2 weeks orally at the doses described, added to the standard treatment of COVID-19.

• Control group: placebo for 2 weeks orally added to standard COVID-19 treatment.

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

Details

• Lead Sponsor: Asociacion Instituto Biodonostia

Criteria

Inclusion Criteria:

• 1 - Acute symptoms compatible with SARS-CoV-2 infection: fever, cough, myalgia, dysgeusia / ageusia, dyspnea, pulmonary infiltrates on X-ray / CT, or any sign / symptom attributable to said infection

• 2. Microbiologically confirmed infection by SARS-CoV-2 (PCR and / or CLIA or ELISA serology or with a valid microbiological diagnostic test with antigen test).

• 3.> 18 years.

• 4. <2 weeks from the onset of symptoms.

• 5. Admitted (with or without pneumonia) and ambulant (with pneumonia demonstrated by X-ray or CT)

• 6. Some analytical degree of moderate inflammation defined by PCR between 20 and 80 mg / L and / or ferritin between the high limit of normality (LAN) and 3 times said LAN

• 7. Signing of the Informed Consent, or acceptance of oral consent before witnesses.

Exclusion Criteria:

• 1. Drug allergy.

• 2. Intolerance to lactose and / or cow's milk proteins.

• 3. Renal failure with GFR <30 ml / min.

• 4. Liver cirrhosis or severe liver failure

• 5. Pregnancy or breastfeeding.

• 6. Blood dyscrasias or cardiac disorders that in the opinion of the investigator contraindicate the use of colchicine.

• 7. Pre-existing degenerative neuromuscular disease.

• 8. Acute or chronic diarrhea or malabsorptive syndrome that in the judgment of the clinician contraindicates the use of colchicine.

• 9. CRP> 80 mg / L or ferritin> 3 times LAN

• 10. Shock or hemodynamic instability.

• 11. Respiratory distress measured by PaO2 / FIO2 <300 or baseline O2 saturation ≤ 93%.

• 12. Patients undergoing mechanical ventilation.

• 13. Chronic treatment with any drug that, in the opinion of the investigator, interacts with colchicine and cannot be discontinued during the clinical trial, unacceptably increasing the risk of toxicity (digoxin, cyclosporine, etc.)

• 14. Have received any dose of colchicine, tocilizumab, any antiL6 or antiL1 drug.

• 15. Current treatment with corticosteroids (except chronic corticosteroid therapy without recent increase in dose).

• 16. Participation in any other clinical trial of patients with COVID-19.

• 17. Any other condition that, in the opinion of the investigator, contraindicates the use of colchicine or puts the subject at risk due to their participation in the study.