Analysis of Laboratory Markers for Severe COVID-19
NCT Number: NCT06460753
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Coronavirus Infection COVID-19
Interventions: DIAGNOSTIC_TEST: CT of the chest organs, blood biochemical parameters
Sponsor: Karaganda Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 193
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-10
Completion Date: 2024-06-10
Locations: Karaganda Medical University, Karaganda, 100008, Kazakhstan

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.

Primary Outcome Measures: Biochemical markers' correlation with outcomes, In the early stages of hospitalization was found the significant inverse correlation (p \< 0.01, r -0.236) with the outcome of the stay for procalcitonin levels on the third day - larger concentrations of this marker were associated with death for the patient; on day 7 - weaker inverse correlation (p \< 0.05, r -0.246), by the end of treatment - a significant inverse correlation at p \< 0.001, r -0.393. A correlation between D-dimer and the outcome of the stay was revealed - on the 3rd day and at the end of treatment - in both cases the correlation is inverse, quite significant (p \< 0.01, r-0.237and p \< 0.001, r-0.512 respectively). Higher ferritin levels correlated with death when determined in the late period of hospitalization - inverse correlation at p \< 0.001, r-0.447., Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.|Markers as outcome predictors, According to the results of ROC analysis predictively significant for mortal outcome (\*AUC values are close to 1.0, at the significance level P =0.05) were: procalcitonin level on days 3, 7 and 15, CRP level on days 7 and 15, levels of D-dimer on days 3, 7 and 15, ferritin on days 3 and 7, Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
Secondary Outcome Measures: the correlation between the level of biomarkers and the degree of infiltration of lung tissue, The correlation between the level of biomarkers and the degree of infiltration of lung tissue (CRP, D-dimer, ferritin at the beginning of treatment and at the end of treatment, procalcitonin at the end of treatment) was identified. This correlation was direct in all cases., Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.|The level of D-dimer quite significantly negatively correlated with the duration of stay in the intensive care unit, The level of D-dimer quite significantly (p \< .001) negatively correlated with the duration of stay in the intensive care unit when assessed on days 1, 3 and at the end of treatment, but such a correlation was not detected on day 7., Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.|The inverse correlation was found for procalcitonin and the patient-bed-days in the intensive care unit, The inverse correlation was found for procalcitonin and the duration of patient's stay in the intensive care unit - on day 3 (p \< .05) and at the end of treatment (p\< .01)., Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.