Observational Study of Follow-up of Hospitalized Patients Diagnosed With COVID-19 to Evaluate the Effectiveness of the Drug Treatment Used to Treat This Disease. COVID-19 Registry ( RegCOVID19 )

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  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:
  Viral infection
• Additional medical condition(s):
  SARS-Cov-2 infection,COVID-19

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice, measured in terms of clinical stability, recovery and mortality.
• Outcomes:
  - %Response to treatment and time to response, defined as clinical stability 3-4 days after treatment (FC<100lpm, FR<24RPM, axillary temperature<37.2ºC, SaO2>90% and adequate level of consciousness). - %Recovery and time to recovery defined as disappearance of symptoms and 2 consecutive negative PCRs at least 24 hours apart. - Mortality and time to death. - %hospitalization in the ICU. - Suspected adverse reactions to the treatments received: type, severity, prior knowledge, outcome. - Quality of life questionnaire on care received during hospitalization and after recovery.
• Data analysis plan:
  As it is a registry, the aim is to include as many patients as possible without initially having a predetermined number. Descriptive statistics of the various variables in the record (both categorical and quantitative variables) will be carried out. In addition, provided that sufficient data is available, comparisons will be made of the result variables according to the different treatments received by the patients using the chi-square test as well as applying multivariate analysis techniques. The Cox regression model will be used to analyse the time variables (time to response, recovery or death) and the influence of the drug treatment received and other prognostic variables.