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

Tom Schoenmakers; Bas C T van Bussel; Stefan H M Gorissen; Inge H M van Loo; Frank van Rosmalen; Wilhelmine P H G Verboeket-van de Venne; Petra F G Wolffs; Walter N K A van Mook; Mathie P G Leers

doi:10.1136/bmjopen-2022-069455

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

Tom Schoenmakers^*, Bas C T van Bussel, Stefan H M Gorissen, Inge H M van Loo, Frank van Rosmalen, Wilhelmine P H G Verboeket-van de Venne, Petra F G Wolffs, Walter N K A van Mook, Mathie P G Leers

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Article number	e069455
Number of pages	7
Journal	BMJ Open
Volume	13
Issue number	2
DOIs	https://doi.org/10.1136/bmjopen-2022-069455
Publication status	Published - 28 Feb 2023

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Schoenmakers, T., Bussel, B. C. T. V., Gorissen, S. H. M., Loo, I. H. M. V., Rosmalen, F. V., Venne, W. P. H. G. V. D., Wolffs, P. F. G., Mook, W. N. K. A. V., & Leers, M. P. G. (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. BMJ Open, 13(2), Article e069455. https://doi.org/10.1136/bmjopen-2022-069455

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title = "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",

abstract = "Introduction To investigate whether biochemical and haematological changes due to the patient{\textquoteright}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.",

author = "Tom Schoenmakers and Bussel, {Bas C T van} and Gorissen, {Stefan H M} and Loo, {Inge H M van} and Rosmalen, {Frank van} and Venne, {Wilhelmine P H G Verboeket-van de} and Wolffs, {Petra F G} and Mook, {Walter N K A van} and Leers, {Mathie P G}",

year = "2023",

month = feb,

day = "28",

doi = "10.1136/bmjopen-2022-069455",

language = "English",

volume = "13",

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Schoenmakers, T, Bussel, BCTV, Gorissen, SHM, Loo, IHMV, Rosmalen, FV, Venne, WPHGVD, Wolffs, PFG, Mook, WNKAV & Leers, MPG 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', BMJ Open, vol. 13, no. 2, e069455. https://doi.org/10.1136/bmjopen-2022-069455

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. / Schoenmakers, Tom; Bussel, Bas C T van; Gorissen, Stefan H M et al.
In: BMJ Open, Vol. 13, No. 2, e069455, 28.02.2023.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Validating a clinical laboratory parameter-based deisolation algorithm for patients with COVID-19 in the intensive care unit using viability PCR

T2 - the CoLaIC multicentre cohort study protocol

AU - Schoenmakers, Tom

AU - Bussel, Bas C T van

AU - Gorissen, Stefan H M

AU - Loo, Inge H M van

AU - Rosmalen, Frank van

AU - Venne, Wilhelmine P H G Verboeket-van de

AU - Wolffs, Petra F G

AU - Mook, Walter N K A van

AU - Leers, Mathie P G

PY - 2023/2/28

Y1 - 2023/2/28

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2022-069455

DO - 10.1136/bmjopen-2022-069455

M3 - Article

SN - 2044-6055

VL - 13

JO - BMJ Open

JF - BMJ Open

IS - 2

M1 - e069455

ER -

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

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