Coronavirus Infection COVID-19NCT06460753
Analysis of Laboratory Markers for Severe COVID-19
An observational study of Coronavirus Infection COVID-19, run by Karaganda Medical University at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection COVID-19
- What is being tested?
- CT of the chest organs, blood biochemical parameters
- How many people
- 193 participants
- Where
- 1 siteKazakhstan
- Study dates
- 10 Apr 2024to 10 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- identified COVID-19 by nasopharyngeal material PCR, coronavirus associated lung infiltration, visualized by CT, and clinically severe condition
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Coronavirus Infection COVID-19
- Being tested
- CT of the chest organs, blood biochemical parameters
- Keywords
- coronavirus infection, COVID-19, biochemical markers, forecasting, outcomes, resuscitation and intensive care
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT of the chest organs, blood biochemical parametersDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| hospitalized to ICU severe patients with coronavirus infection COVID-19 | an analysis of the medical records was carried out Receives: Diagnostic Test: CT of the chest organs, blood biochemical parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start10 Apr 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Infection COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaganda Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aissulu Issabekova, MD, Study chair, Karaganda Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460753
- Sponsor's protocol ID
- SC19MI-ARICU-1T
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Laboratory Markers for Severe COVID-19
- ClinicalTrials.gov ID
- NCT06460753
- Acronym / sponsor ID
- SC19MI-ARICU-1T
- Conditions
- Coronavirus Infection COVID-19
- Keywords
- coronavirus infection, COVID-19, biochemical markers, forecasting, outcomes, resuscitation and intensive care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Karaganda Medical UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hospitalized to ICU severe patients with coronavirus infection COVID-19 | – | Diagnostic Test: CT of the chest organs, blood biochemical parametersan analysis of the medical records was carried out |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- identified COVID-19 by nasopharyngeal material PCR, coronavirus associated lung infiltration, visualized by CT, and clinically severe condition
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT of the chest organs, blood biochemical parametersTaking 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. | Diagnostic test | hospitalized to ICU severe patients with coronavirus infection COVID-19 |
Primary outcome
Biochemical markers' correlation with outcomes
Time frame: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
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.
Markers as outcome predictors
Time frame: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
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
3 secondary outcomes
the correlation between the level of biomarkers and the degree of infiltration of lung tissue
Time frame: 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
Time frame: 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
Time frame: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aissulu Issabekova, MD study chair
Karaganda Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection COVID-19, run by Karaganda Medical University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical markers' correlation with outcomes (time frame: Laboratory markers were measured daily. For correlation analysis, control days of measurements were chosen: days 1-3-7-15.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.