COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04472611

Alexandra Lansky

Not reported

2020-07-15

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria 1.18 years or older and confirmed sars-cov-2 infection by rt-pcr 2. patient is admitted to the floor (non-icu) within 48 hours of hospital admission 3. the patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided witnessed (by 2 independent members of the health care team) oral informed consent, or a photograph of the signed informed consent approved by the institutional review board (irb)

known pregnancy or nursing mothers known allergy to statins or colchicine patient is on chronic colchicine or oral corticosteroid treatment acute liver disease defined by elevated transaminases (ast/alt > 3x uln) severe chronic kidney disease defined as glomerular filtration rate (gfr) < 30ml/min1.73 m2 severe qtc prolongation (>500ms narrow qrs<120ms and >550ms for wide qrs>120) presents with severe disease on admission (who ordinal scale of clinical improvement scores 5-8) rhabdomyolysis or cpk > 5x uln thrombocytopenia defined as platelet count < 50,000 / mm3 leukopenia defined as white blood cell count < 3000 ml severe anemia defined as hemoglobin value <8 g/100ml participation in any other clinical trial of an experimental treatment for covid-19

2

Yale University

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

250

Number of Participants With COVID 19 Severity

None

Phase 3

[{"arm_notes": "", "treatment_id": 1471, "treatment_name": "Colchicine+rosuvastatin", "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"}]