Protocol for a prospective, observational, hospital-based multicentre study of nosocomial SARS-CoV-2 transmission: NOSO-COR Project

BMJ Open. 2020 Oct 22;10(10):e039088. doi: 10.1136/bmjopen-2020-039088.

Abstract

Introduction: The newly identified SARS-CoV-2 can cause serious acute respiratory infections such as pneumonia. In France, mortality rate in the general population was approximately 10% and could reach higher levels at the hospital. In the current context of high incidence rates of SARS-CoV-2 in the community, a significant increase in the rate of nosocomial transmission is expected. The risk of nosocomial transmission could even be higher in low-income countries that have fragile healthcare systems. This protocol is intended to estimate the prevalence and incidence of suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective) at participating hospitals.

Methods and analysis: This will be an international multicentre prospective, observational, hospital-based study in adults and children. It will include volunteer patients and healthcare professionals in France and hospitals affiliated with the GABRIEL network. Demographic and clinical data will be collected using case report forms designed especially for the purpose of the project. A nasopharyngeal swab will be collected and tested for SARS-CoV-2 by reverse-transcriptase PCR. Characteristics of the study participants, the proportion of confirmed nosocomial SARS-CoV-2 infections relative to all patients with syndromes suggestive of SARS-CoV-2 infection, will be analysed. Appropriate multivariate modelling will be used to identify the determinants associated with nosocomial onset.

Ethics and dissemination: This study was approved by the clinical research and committee of all participating countries. The findings will be submitted to peer-reviewed journal for publication and shared with national health authorities.

Trial registration number: NCT04290780.

Keywords: epidemiology; infection control; infectious diseases; protocols and guidelines; public health.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Betacoronavirus*
  • COVID-19
  • Child
  • Coronavirus Infections / epidemiology
  • Coronavirus Infections / transmission*
  • Cross Infection / epidemiology*
  • Female
  • France / epidemiology
  • Hospitals / statistics & numerical data*
  • Humans
  • Male
  • Middle Aged
  • Pandemics*
  • Pneumonia, Viral / epidemiology
  • Pneumonia, Viral / transmission*
  • Prospective Studies
  • Risk Factors
  • SARS-CoV-2
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT04290780