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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hospitalized to ICU severe patients with coronavirus infection COVID-19 | an analysis of the medical records was carried out |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT of the chest organs, blood biochemical parameters | Diagnostic Test | Taking into account the clinical manifestations, all patients underwent chest computed tomography (CT) to diagnose COVID-19-associated pneumonia. According to the CT results, all patients were classified into one of 4 subgroups, according to the degree of pulmonary infiltration. The following biochemical parameters were selected and used to monitor dynamics: procalcitonin (PCT), C-reactive protein (CRP), D-dimer (DD), ferritin (FRT). Biochemical markers were determined daily during the stay in the intensive care unit. The duration of observation was 15 days was selected. Information was analysed retrospectively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients hospitalized in the intensive care unit of the Regional Clinical Hospital of Karaganda, which is the clinical base of the Karaganda Medical University.
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| Name | Affiliation | Role |
|---|---|---|
| Aissulu Issabekova, MD | Karaganda Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaganda Medical University | Karaganda | 100008 | Kazakhstan |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 25, 2024 | |
| Reset | Sep 27, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2024 | Jun 12, 2024 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 25, 2024 | Sep 27, 2024 |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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biochemical parameters: procalcitonin, C-reactive protein, D-dimer, ferritin
|
| 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. |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |