Real-world characteristics, management and outcomes of subjects screened or diagnosed with COVID-19 in Spain (COVID-19 REAL)

Study type

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

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Pneumonia
• Additional medical condition(s):
  COVID-19PneumoniaViral Infection

Population studied

• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  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)
• Estimated number of subjects:
  8000

Study design details

• Main study objective:
  Describing the characteristics of subjects screened and/or diagnosed with COVID-19 in Spain Describing therapeutic management in the clinical practice Describing clinical outcomes for the infected subjects Assessing predictor factors for infection, hospitalization,intensive care admission and death Exploring effectiveness and safety of administered therapies
• Outcomes:
  Sociodemographic and lifestyle Geographical/Ethnic origin History of exposure to COVID-19 and dates, test results and viral load, if available Current and past concomitant medications Current and past comorbidities Diagnosis, clinical symptoms and signs Laboratory values Severity scores, Infection status Pneumonia status Recovery status and time to recovery Hospitalization and length of stay ICU admission and length of stay Overall survival Complications during infection (bacterial pneumonia, sepsis…) Recurrence/reinfection
• Data analysis plan:
  Descriptive analysis in the overall sample and by subgroups of interest (e.g. Hospital, gender, age subgroups, smoking history, diabetes status, cardiovascular history etc.) Multivariable Cox Regression to estimate Hazard ratios Multivariable Logistic Regression to estimate Odds ratios

Documents

Study publications

Reyes C, Pistillo A, Fernández-Bertolín S, Recalde M, Roel E, Puente D, Sena AG…

Kostka K, Duarte-Salles T, Prats-Uribe A, Sena AG, Pistillo A, Khalid S, Lai LY…