A retrospective study to evaluate the clinical effectiveness and safety of treatments for Covid-19 hospitalised patients and to determine prognostic factors. (RAPID COVID-19)

Study type

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

  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:
  HYDROXYCHLOROQUINE

  LOPINAVIR

  RITONAVIR

  AZITHROMYCIN

  REMDESIVIR

  INTERFERON ALFA-2B

  INTERFERON BETA-1A

  INTERFERON BETA-1B

  TOCILIZUMAB

  SARILUMAB

  SARS-COV-2 CONVALESCENT PLASMA

  DARUNAVIR

  COBICISTAT
• Medical condition to be studied:
  COVID-19

Population studied

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

  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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To compare in-hospital clinical status in patients with Covid-19 treated with standard care and various treatments and determine prognostic factors.
• Outcomes:
  6-point ordinal scale at 14 days:, 6-point ordinal scale at 7 and 28 days, In-hospital death at 28 days, mechanical ventilation, renal replacement therapy, duration of hospitalization, duration of ICU stay, serious complications and serious adverse eventsPrediction score
• Data analysis plan:
  The primary analysis will use an ordered polytomous logistic regression model to assess 14 day in-hospital clinical status on a 6-point ordinal scale, with adjustments. Results will be presented as odds ratios Secondary analysis of death at 28 days will use logistic regression, also with adjustments.Multivariable ordered polytomous logistic regression will be used to determine key predictors of the primary ordinal scale outcome. Multivariable logistic regression will be used to determine key predictors of the secondary outcome of death at 28 days, mechanical ventilation and renal replacement therapy. The final predictive model will be converted into a clinician-friendly index.