Protocol for a multicentre study of nosocomial SARS-CoV2 transmission The NOSO-COR Project

ABSTRACT

IntroductionThe newly identified SARS-CoV2 can cause serious acute respiratory infections such as pneumonia with a mortality rate of approximately 2% to 4%. In the current context of high incidence rates of SARS-CoV2 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 study and document suspected or confirmed cases of nosocomial SARS-CoV2 infection, the clinical spectrum and the determinants (risk factors/protective) at participating hospitals. Methods and analysisThis will be an international multicentre prospective, observational, hospital-based study in adults and children. It will include volunteer patients, care givers 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-CoV2 by RT-PCR. Characteristics of the study participants, the proportion of confirmed nosocomial SARS-CoV2 infections relative to all patients with syndromes suggestive of 2019-nCoV infection will be analysed. Appropriate multivariate modelling will be used to identify the determinants associated with nosocomial onset. Ethics and disseminationThis study was approved by the clinical research and committee of Ile de France V on March 8, 2020. Registration detailsThe trial was registered in ClinicalTrials (NCT04290780). Strengths and limitations of the study[tpltrtarr] This prospective study will generate and evaluate original data on nosocomial SARS-CoV2 infection in France and in the low-income countries of the GABRIEL network using the same protocol and standardised CRF. [tpltrtarr]The results will provide the opportunity to compare the management of nosocomial Covid-19 infection in different settings for mutual exchanges and optimisation. [tpltrtarr]The results will make it possible to refine the definition of nosocomial SARS-CoV2 infection, strengthen preventive campaigns for in-hospital transmission of SARS-CoV2 and pave the way for new recommendations in terms of preventive measures. [tpltrtarr]Selection bias owing to access to care in different populations and bias owing to the extent of access to personal protective equipment, in particular, in low-income countries may occur. [tpltrtarr]The non-exhaustivity of the confounders to be collected should be considered for interpretation of the results.