Project Sc(y)lla: SARS-Cov-2 Large-scale Longitudinal Analyses on the comparative safety and effectiveness of treatments under evaluation for COVID-19 across an international observational data network

Study type

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

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Corticosteroids, Interleucin inhibitors, JAK inhibitors, Statins, Anti-diabetics, Protease inhibitors, Anticoagulants
• Study drug International non-proprietary name (INN) or common name:
  HYDROXYCHLOROQUINE
• Anatomical Therapeutic Chemical (ATC) code:
  (C02) ANTIHYPERTENSIVES

  ANTIHYPERTENSIVES

  (J02AA) Antibiotics

  Antibiotics
• Medical condition to be studied:
  COVID-19 treatment

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)
• Estimated number of subjects:
  2500000

Study design details

• Main study objective:
  Specifically, the study has the following objectives:1. To assess comparative effectiveness and safety among treatments administered during hospitalization and prior to intensive services2. To assess comparative effectiveness and safety among treatments administered after COVID-19 positive testing or diagnosis in outpatient setting without prior hospitalization
• Data analysis plan:
  One study design, with multiple different analysis variants, will be conducted after appropriate diagnostics to rule out power and/or confounding issues. For each research question in section 8, we have identified treatments that 1) have in vitro antiviral activity for SARS-COV-2 virus, or 2) are considered concomitant therapies for the COVID-19 disease. The latter are subdivided into antithrombotics, antibiotics, immune-based therapies, concomitant anti-hypertensive, concomitant anti-diabetics, concomitant statin, and other concomitant treatments (see Appendix 1). For each question, we will make pairwise comparisons of all treatments within these eight categories of therapies (e.g. compare all drugs with antiviral activity against each other, and separately compare all antithrombotic therapies with each other). For each comparison, we will estimate and compare the incidences of each outcome in Appendix 2 during the time-at-risk windows defined in 9.2.3.