EFFECTIVENESS AND SAFETY OF CORTICOSTEROIDS IN SARS-COV-2 INFECTION (COVID-19): COHORT STUDY (CORTICOV-19)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (H02AB04) methylprednisolone

  methylprednisolone
• Medical condition to be studied:
  Coronavirus test positive

  Pneumonia

Population studied

• Short description of the study population:
  Adult patients admitted to Hospital Puerta de Hierro-Majadahonda between 4 March 2020 and 7 April 2020 with a diagnosis of COVID-19 pneumonia according to WHO interim guidance and complicated with ARDS and/or an hyperinflammatory syndrome where included. Of them, patients who received corticosteroid therapy according to clinical practice were assigned to the steroid cohort, while patients who did not were assigned to the control cohort.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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 patients
• Estimated number of subjects:
  463

Study design details

• Main study objective:
  To assess the effectiveness and safety of the use of corticosteroids in the treatment of interstitial pneumonia due to COVID19 in the hospital ward to prevent the need for mechanical ventilation, ICU admission, or death.
• Outcomes:
  % of patients presenting an event during the follow-up period.Event is defined as: progression to a score of 5, 6 or 7 on the 7-point Ordinale Scale (WHO) after admission by COVID-19. Time to eventMortalityHospitalization in ICU% of patients in need of oxygen therapy in each of its modalities (nasal glasses / mask / reservoir / high flow / NIMV or VM / ECMO)Days free of oxygenHospitalization timeChange in the analytical levels: Lymphocytes, Neutrophils, Dimero D, Act prothrombin, C-reactive protein, LDH, GOT, Ferritin, IL6
• Data analysis plan:
  The incidence in exposed (cohort treated with corticosteroids) and in non-exposed (untreated cohort) will be calculated for each of the effectiveness variables. From these, the measures of association relative risk (RR), absolute risk reduction (RAR) and relative risk reduction (RRR) will be calculated for each of the variables, with their 95% CIs. Additionally, the odds ratios (OR) will be calculated. The RR adjusted for comorbidities and prognostic factors will be estimated.