Methyl-prednisolone pulses in COVID-19 pneumonia (COV2-MIIHUC)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  METHYLPREDNISOLONE
• Medical condition to be studied:
  COVID-19 pneumonia

Population studied

• Short description of the study population:
  Patients with COVID-19 pneumonia admitted between 1st March and 30th April 2020 to the services of Infectious Diseases and Internal Medicine of Hospital Universitario Cruces.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  COVID-19 pneumonia patients
• Estimated number of subjects:
  353

Study design details

• Main study objective:
  To analyse the effects of methyl-prednisolone pulses during the second week on the clinical course of patients with COVID-19 pneumonia.
• Outcomes:
  Death.Death or intubation. Nosocomial infections.
• Data analysis plan:
  Adjusted Cox proportional risk models were fitted to assess the effect of the dichotomous variable week-2-MP as the predictor of main interest. The aforementioned variables were included in the full model. Likelihood ratio tests were used in a sequential fashion in order to find a reduced adjusted model containing statistically significant covariates. Hazard ratios (HR) with 95% confidence intervals were used to estimate the magnitude of the association between risk predictors and outcomes. Proportionality of hazards was tested through the use of comparison of adjusted and predicted survival curves and Schoenfeld residuals.