VILA-COVID 19 RETROSPECTIVE OBSERVATIONAL CLINICAL STUDY PROTOCOL: EARLY ADMINISTRATION OF CORTIC THERAPY AND ANTI-INFLAMMATORIES IN PATIENTS WITH COVID 19 DIAGNOSIS. (COVID-19) (VILACOVID 19-CTC)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Respiratory failure

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • 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:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  he objective of our study is to record our experience in the treatment of patients with COVID 19, to assess the results of those who have received corticosteroid therapy, anti-inflammatory drugs (colchicine and / or indomethacin), biological therapies (tocilizumab and / or anakinra) and immunoglobulins, quantifying the evolution of the acute phase reactants of these patients.
• Outcomes:
  Describe our findings in patients diagnosed with COVID 19+ who have received early corticosteroid therapy, in relation to oxygen requirements and / or need for IOT, and compare these findings with the results of patients diagnosed with COVID 19 + who have not received early corticosteroid therapy in the same period of time. Describe the optimal time of administration of early corticosteroid therapy based on the clinical, analytical, PAFI (or SAFI) and radiological characteristics Describe the time of early administration based on the age of the patient. Describe the clinical, analytical and radiological findings if tocilizumab, anakinra or Immuglobulines have been administered. Describe the days of hospitalization
• Data analysis plan:
  The statistical analysis will be done using spss version 22.0. It will include the following procedures: Description of the variables. We will use means and standard deviation in cases of continuous variables with normal distribution, and means with interquartile intervals for continuous variables that do not meet normality criteria. Qualitative variables will be expressed with names and percentages. Chi-square or Fisher's test statistical techniques were used to compare the qualitative variables. For the quantitative variables that meet the normality criteria, Student's T will be used, for those that do not follow the normal distribution, parametric n tests will be used (Mann-Whitney U). The differences between groups they will be carried out using linear models with the practice of ultrasound study as a grouping variable and clinical parameters as adjustment covariates.