Clinical trial NCT06460753: Analysis of Laboratory Markers for Severe COVID-19
Official title: Analysis of Laboratory Markers for Severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection COVID-19
Keywords: coronavirus infection
COVID-19
biochemical markers
forecasting
outcomes
resuscitation and intensive care
Lead sponsor: Karaganda Medical University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in the intensive care unit of the Regional Clinical Hospital of Karaganda, which is the clinical base of the Karaganda Medical University.

Brief summary: The course of coronavirus infection was often severe and required hospitalization of patients in the intensive care unit. The new SARS-Cov-2 has been poor studied, so relatively reliable markers are needed to effectively monitor patients and predict complications and outcome. Taking into account the known mechanisms of pathogenesis, the biochemical markers as ferritin, procalcitonin, C-reactive protein and D-dimer were chosen for this purpose. Patients were divided according to the degree of pulmonary infiltration. We hypothesized that the markers would correlate with dynamics, complications, and outcomes.

Detailed description: In the presented study, an analysis of the medical records of 193 patients hospitalized in severe condition to the intensive care unit with a confirmed diagnosis of Coronavirus infection COVID-19 was carried out. Taking into account the volume of pulmonary infiltration according to computer tomography (CT) of the chest organs, patients were divided into 4 groups in accordance with the approved classification: CT 1(up to 25% of lung tissue was infiltrated) - 27 patients, CT 2 (25-50%) - 60 patients, CT 3 (50-75%) - 67 patients, CT 4 (75% and more) - 39 patients. The following biochemical parameters were selected and used to monitor dynamics: procalcitonin (PCT), C-reactive protein (CRP), D-dimer (DD), ferritin (FRT). The duration of observation was 15 days.

In order to determine correlations between quantitative and qualitative data at different stages of treatment, a correlation analysis was carried out (Spearman's test was used). ROC analysis was performed to evaluate selected laboratory markers as predictors of outcome. Next, the odds ratio (OR) was assessed taking into account the obtained Youden's J index and the Associated criterion for each of the selected markers in relation to the patient's outcome. Preliminary contingency tables were compiled in relation to laboratory parameters and outcomes (2x2 tables).

Data were processed using statistical software jamovi (Computer Software ,Version 2.3.26), MedCalc (MedCalc Software Ltd, Ostend, Belgium), Microsoft Office Excel, 2016.

Eligibility criteria: Inclusion Criteria:

* identified COVID-19 by nasopharyngeal material PCR, coronavirus associated lung infiltration, visualized by CT, and clinically severe condition

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Biochemical markers' correlation with outcomes
timeFrame: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
measure: Markers as outcome predictors
timeFrame: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
Secondary outcomes:
measure: the correlation between the level of biomarkers and the degree of infiltration of lung tissue
timeFrame: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
measure: The level of D-dimer quite significantly negatively correlated with the duration of stay in the intensive care unit
timeFrame: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
measure: The inverse correlation was found for procalcitonin and the patient-bed-days in the intensive care unit
timeFrame: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
Other outcomes:
Locations:
city: Karaganda
country: Kazakhstan
facility: Karaganda Medical University
Study officials:
affiliation: Karaganda Medical University
name: Aissulu Issabekova, MD
role: STUDY_CHAIR
References: