Department of Clinical Chemistry and Hematology, Zuyderland Medical Centre, Sittard-Geleen/Heerlen, The Netherlands
School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, The Netherlands.
BMJ Open. 2023 Feb 28;13(2):e069455. doi: 10.1136/bmjopen-2022-069455.
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.
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.
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.
为了研究由于患者宿主反应（CoLab 算法）与 SARS-CoV-2 存活 PCR（v-PCR）相结合而导致的生化和血液学变化是否可用于确定 COVID-19 患者是否不再具有传染性，我们假设 CoLab 算法与 v-PCR 结合可用于确定 COVID-19 患者是否具有传染性，以促进 COVID-19 患者从隔离中安全释放。
本研究由三个部分组成，使用三个不同的 COVID-19 患者队列。所有三个队列均包含临床、生命体征和实验室参数，以及与 COVID-19 隔离患者相关的逻辑数据，重点关注重症监护病房（ICU）住院情况。第一队列将用于开发 COVID-19 患者宿主反应生化和血液学变化过程的算法。同时，第二个前瞻性队列将用于研究第一队列中得出的算法，每天测量实验室参数，除了常规的 SARS-CoV-2 逆转录酶 PCR 外，还将进行 v-PCR，以确认患者体内存在完整的 SARS-CoV-2 颗粒。最后，第三个多中心队列将由 ICU 收治的 COVID-19 患者的回顾性数据组成，用于验证该算法。
这项研究得到了 Maastricht University Medical Centre+ 医学伦理委员会（队列 I：2020-1565/300523）和 Zuyderland MC（队列 II 和 III：METCZ20200057）的批准。所有患者都需要提供知情同意。该研究的结果将通过同行评议的期刊和会议/联盟报告进行传播。
