EFFECTIVENESS AND SAFETY OF TOCILIZUMAB IN INTERSTITIAL PNEUMONIA WITH SERIOUS RESPIRATORY FAILURE SECONDARY TO SARS-COV-2 INFECTION (COVID-19): COHORT STUDY (TOCICOV-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:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TOCILIZUMAB
• Medical condition to be studied:
  Coronavirus test positive

  Pneumonia

  COVID-19

Population studied

• Short description of the study population:
  The study population were adult patients (≥ 18 years) with COVID-19, confirmed by PCR on nasopharyngeal swab, who were consecutively admitted to the participating hospitals between 3 March and 20 April 2020.
• 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:
  393

Study design details

• Main study objective:
  To assess the effectiveness and safety of tocilizumab in the treatment of interstitial pneumonia due to COVID19 with severe respiratory failure treated at the hospitalization ward to prevent the need for mechanical ventilation and ICU admission.
• Outcomes:
  % of patients with an event on day 15. Event is defined as: admission to the ICU by COVID-19 or death after admission by COVID-19. % of patients with an event on the day on days 1, 3, 7 and 29. Time to event Mortality on day 15 and 29 % of patients in need of oxygen therapy in each of its modalities Hospitalization time Change in the analytical levels % of patients with SAEs
• Data analysis plan:
  490/5000 The incidence in exposed (cohort treated with tocilizumab) 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.