Spanish Registry of treatment efficacy against SARS-CoV-2 COVID-19 (RER-FAR-COVID-19)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  AZITHROMYCIN

  CHLOROQUINE

  COBICISTAT

  DARUNAVIR

  EMTRICITABINE

  FOSAMPRENAVIR

  HYDROXYCHLOROQUINE SULFATE

  INTERFERON BETA-1B

  LOPINAVIR

  REMDESIVIR

  RITONAVIR

  TENOFOVIR

  TOCILIZUMAB
• Medical condition to be studied:
  Pneumonia
• Additional medical condition(s):
  SARS-CoV-2 infection

Population studied

• Age groups:
  • 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:
  Hepatic impaired

  Immunocompromised

  Renal impaired
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  To Evaluate the effectiveness of pharmacotherapy used in the treatment of cases of SARS-CoV2 coronavirus infection who have required hospital admission in Spain during the pandemic declared in March 2020.
• Outcomes:
  Remission rate of the disease at 14 days (proportion, 95% CI), understanding remission as:- Improvement of symptoms (fever, cough ...) together with radiological improvement and/or- PaFi> o = 300 mm Hg or O2 saturations> 93 without O2 administration.
• Data analysis plan:
  Accordind the exceptional situation, no sample size has been calculated to achieve the primary objective. However, intermediate analyzes will be made based on the inclusion of completed cases (discharge / exitus or 14 days of treatment) every week. The beta error of each of the treatment groups will be calculated from each analysis cut to determine if the number of patients included is powerful enough to draw conclusions. At least a beta error of 20% (power of 80%) and an alpha error of 5% will be assumed.