Epidemiological study of COVID-19 among hospital employees: extension study of the ‘CovidPreventMainz’ (CPM) study (CPMprevac)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  SARS-CoV-2 test

  SARS-CoV-2 antibody test
• Additional medical condition(s):
  COVID-19 cell-mediated immune responses.,COVID-19 clinical disease.

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  3500

Study design details

• Main study objective:
  This study aims to describe the epidemiology of COVID-19 in a collective of a German university hospital employees (including human medicine and dentistry students with contact to patients) in order to support the initiation, as well as enhance the analytical power, of a field efficacy trial of Curevac’s investigational SARS-CoV-2-mRNA vaccine (CVnCoV).
• Outcomes:
  • Seroconversion due to SARS-CoV-2 infection measured by SARS-CoV-2-specific antibodies in serum samples. • Virologically-confirmed symptomatic COVID-19 clinical disease Case definition 1: FDA, • Virologically-confirmed symptomatic COVID-19 clinical disease Case definition 2: CEPI • Severity of COVID-19 clinical disease Case definition 1: FDA Case definition 2: CEPI • Cell-mediated immune responses in persons with proven SARS-CoV-2 infection • Clinical presentation of suspected COVID-19 cases • Prevalence of asymptomatic SARS-CoV-2 infection
• Data analysis plan:
  The study population will be described using frequency tables and proportions. The prevalence of seroconversions will be calculated absolute, and analysed stratified by age group, sex and other risk factors. Incidence rates (IRs) will be calculated for confirmed COVID-19 disease, using the two described case definitions. Disease severity will be described, using two case definitions.