COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04350320

Domingo A Pascual Figal

dpascual@um.es

2020-04-17

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: sars-cov-2 infection confirmed by pcr. admitted in the hospital in the previous 48 hours, with clinical status 3, 4 or 5 of who classification. age above 18 years old. informed written consent.

invasive mechanical ventilation needed. established limitation of the therapeutic effort inflammatory bowel disease (ibd: chron syndrome or ulcerative colitis), chronic diarrhea or malabsorption. previous neuromuscular disease. other disease with an estimated vital prognosis under 1 year. severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2) medical records of cirrhosis, active chronic hepatitis or severe hepatic disease defined by got or gpt levels three times above the normal upper limit. 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. patients with history of allergic reaction or significant sensitivity to colchicine. treatment with immunosuppressive agents, corticoids or interleukine-1 antagonists for 6 months before inclusion. pregnant or breastfeeding female, confirmed by a positive result in the human chorionic gonadotropin (hcg) test. 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. use of other investigational drugs in the moment of inclusion, or during 30 days previous to inclusion.

2

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

18

None

Spain

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

102

Changes in the patients' clinical status through the 7 points ordinal scale WHO R&D Blueprint expert group;Changes in IL-6 concentrations

None

Phase 3

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]