BMJ Open (Feb 2023)

Validating a clinical laboratory parameter-based deisolation algorithm for patients with COVID-19 in the intensive care unit using viability PCR: the CoLaIC multicentre cohort study protocol

  • ,
  • Albert Wolthuis,
  • Petra F G Wolffs,
  • Tim Frenzel,
  • Mathie P G Leers,
  • Frank van Rosmalen,
  • Steven JR Meex,
  • Otto Bekers,
  • Bas C T van Bussel,
  • Inge H M van Loo,
  • Guy JM Mostard,
  • Rémy LM Mostard,
  • Arjen-Kars Boer,
  • Ruben Deneer,
  • Tom Schoenmakers,
  • Stefan H M Gorissen,
  • Wilhelmine P H G Verboeket-van de Venne,
  • Walter N K A van Mook,
  • Stephanie MC Ament,
  • M Sesmu Arbous,
  • Miranda van Berkel,
  • Dirck W van Dam,
  • William PTM van Doorn,
  • Tom P Dormans,
  • Silvia MAA Evers,
  • Judith Gillis,
  • Iwan CC van der Horst,
  • W Nadia H Koek,
  • Kitty CFM Linssen,
  • Luuk C Otterspoor,
  • Natal AW van Riel,
  • Frans Stals

DOI
https://doi.org/10.1136/bmjopen-2022-069455
Journal volume & issue
Vol. 13, no. 2

Abstract

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Introduction To investigate whether biochemical and haematological changes due to the patient’s host response (CoLab algorithm) in combination with a SARS-CoV-2 viability PCR (v-PCR) can be used to determine when a patient with COVID-19 is no longer infectious.We hypothesise that the CoLab algorithm in combination with v-PCR can be used to determine whether or not a patient with COVID-19 is infectious to facilitate the safe release of patients with COVID-19 from isolation.Methods and analysis This study consists of three parts using three different cohorts of patients. All three cohorts contain clinical, vital and laboratory parameters, as well as logistic data related to isolated patients with COVID-19, with a focus on intensive care unit (ICU) stay. The first cohort will be used to develop an algorithm for the course of the biochemical and haematological changes of the host response of the COVID-19 patient. Simultaneously, a second prospective cohort will be used to investigate the algorithm derived in the first cohort, with daily measured laboratory parameters, next to conventional SARS-CoV-2 reverse transcriptase PCRs, as well as v-PCR, to confirm the presence of intact SARS-CoV-2 particles in the patient. Finally, a third multicentre cohort, consisting of retrospectively collected data from patients with COVID-19 admitted to the ICU, will be used to validate the algorithm.Ethics and dissemination This study was approved by the Medical Ethics Committee from Maastricht University Medical Centre+ (cohort I: 2020-1565/300523) and Zuyderland MC (cohorts II and III: METCZ20200057). All patients will be required to provide informed consent. Results from this study will be disseminated via peer-reviewed journals and congress/consortium presentations.