COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04997551

Not reported

Not reported

2021-08-09

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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.

- 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.

2

Asociacion Instituto Biodonostia

18

99

Spain

Moderate disease at enrollment

3: Moderate disease at enrollment

752

Each of the items (proportion of patients who suffer death, need for mechanical ventilation and development of respiratory distress) separately on days +7, +14 and +30.;Proportion of patients who present death, need for mechanical ventilation or respiratory distress (Pa02 / FiO2 <300 or baseline O2 saturation ≤93%) on days +7, +14 and +30.

None

Phase 3

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]