COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04539873

Walter Chaves

wchaves@fucsalud.edu.co

2020-09-07

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - patients ≥18 years old. - laboratory-confirmed sars-cov-2 infection: infection confirmed with nasopharyngeal swab by positive rt pcr in the last 48 hours. - hospital admission for covid-19 in the previous 48 hours. - clinical stage 3 (no supplemental oxygen requirement) or 4 (supplemental oxygen requirement for nasal contact lenses or mask) of the who classification (see annex 2). - the patient must be able and willing to provide informed written consent before performing study procedures. - patient confirmed to covid19 as positive by positive pcr test

- pregnancy, nursing mothers, and women of childbearing potential who are unable to use adequate contraception. - known hypersensitivity or other clear contraindication to the use of colchicine. - history of end-stage renal disease (egfr <30 ml / min / 1.73 m2). - medical history of cirrhosis (child-pugh c), liver failure, chronic active hepatitis, or severe liver disease defined by alanine aminotransferase (alt) or aspartate aminotransferase (ast)> 5 times the upper limit of normal. - history of pre-existing neuromuscular disease. - previous severe hematologic disease or bleeding disorders. - inflammatory bowel disease (crohn's disease or ulcerative colitis), chronic diarrhea, or malabsorptive syndrome. - colchicine treatment for other indications. - treatment with immunosuppressive/immunomodulatory agents, including glucocorticoids, antivirals, antimalarials, and il 6 antagonists for 30 days prior to enrollment. - use of other investigational drugs at the time of inclusion, or during the 30 days prior to inclusion. - any medical condition or disease that, in the opinion of the investigator, may place the patient at unacceptable risk to participate in the study.

2

Fundación Universitaria de Ciencias de la Salud

18

100

Colombia

Moderate disease at enrollment

3: Moderate disease at enrollment

128

Number of participants who die or require transfer to Intesive care unit

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"}]