IMPACT OF COLCHICINE ON PREVENTING HOSPITAL ADMISSIONS BY COVID-19: the COLCHI-COVID19 study.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40430
• EU PAS number:
  EUPAS34810
• Study ID:
  40430
• Official title and acronym:
  IMPACT OF COLCHICINE ON PREVENTING HOSPITAL ADMISSIONS BY COVID-19: the COLCHI-COVID19 study.
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  OBJECTIVE: To evaluate whether the ongoing use of colchicine might, in case of SARS-CoV-2 contagion, reduce the risk of hospital admission by COVID19. METHODOLOGY: 1. Design: observational, cross-sectional, analytical study. 2. Study subjects: 2.1. Population: registered inhabitants in the Valencian region (dated April 15, 2020), and with access to the public health system. 2.2. Inclusion criteria: A. Age >=18 years. B. At least one attendance in the last 2 years in Rheumatology of Valencian public hospitals. C. Registered diagnoses (ICD-10 coding): - GOUT (M10.X) - CALCIUM PYROPHOSPHATE CRYSTAL ARTHRITIS (M11.X) - FAMILIAL MEDITERRANEAN FEVER (M04.X) - BEHÇET DISEASE (M35.2) 2.3 Exclusion criteria: none. 2.4. Sample size: The Valencian region, with a population in 2019 of 4974969 inhabitants (INE, 2019), had at April 3, 2020 (M. Health, update nº 64) 2064 hospitalized by COVID19. We estimate that, in the region, there are about 8000 active prescriptions of colchicine. The sample size will likely be sufficient to observe a possible effect of colchicine on hospital admissions for COVID19. 3. Study variables: 3.1. Outcome variables: 3.1.1. Primary: hospital admission for COVID19 3.1.2. Secondary: intrahospital mortality from COVID19 3.2. Explanatory variables: 3.2.1. Primary: active treatment with colchicine in the study period (January to April 2020), with a prescription duration of more than 30 days. Dosing and posology will be recorded. 3.2.2. Secondary variables: Age (in years), Sex, Type of rheumatic disease, concomitant biological therapy. 4. Data analysis: Categorization according to the use of colchicine. In each group, the rate of hospitalization for COVID19 and intrahospital mortality will be analyzed, estimating risks regarding the use of colchicine (odds ratio with 95%CI) by logistic regression. Analyses will be stratified by age (quartiles), sex, type of rheumatic disease and use of biologics.
• Study status:
  Ongoing

Research institution and networks

Institutions

Hospital General Universitario de Alicante (ISABIAL)

Study timelines

Date when funding contract was signed

Actual: 13/04/2020

Study start date

Planned: 25/09/2020

Actual: 01/04/2021

Data analysis start date

Planned: 16/10/2020

Actual: 04/04/2021

Date of interim report, if expected

Planned: 13/11/2020

Date of final study report

Planned: 18/12/2020

Sources of funding

Other

More details on funding

Institute of Sanitary and Biomedical Research of Alicante (ISABIAL)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable