SARS-CoV2
Conditions
Keywords
SARS pneumonia, COVID-19, severe disease, risk factors
Brief summary
As coronavirus disease 2019 (COVID-19) spreads across the world, the intensive care unit (ICU) community must prepare for the challenges associated with this pandemic. Providing an efficient care to the patients of the most severely affected category - intensive care unit (ICU) patients - has become one of the serious problems appearing in the COVID-19 pandemics. A typical patient's clinical portrait in ICU of COVID centers is very similar in different countries, however, the key to improve the treatment results for critically ill patients has not yet been found. Data on predictors of severe course in COVID-19 is limited. Knowledge of predictors of severe course of disease can lead to different selection of therapeutic strategy, determine the group of risk of patients for severe course of disease, and improve outcomes.
Detailed description
The clinical disease (COVID-19) results in critical illness in about 5% of patients. The aim of the study is to identify predictors of the severe pneumonia caused by the SARS-CoV-2 virus, and to describe the clinical features of patients admitted to an ICU of the COVID-center of the Federal Research Clinical Center of Federal Medical & Biological Agency on the first day and in dynamics till discharge from the ICU or death. The demographic and clinical data will be collected. Laboratory data (hemoglobin, lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, IL-6, procalcitonin, glucose level, high-sensitive troponin Т, vitamin D level, signs of the presence of a secondary bacterial infection, immunogram and Instrumental data (CT-scan, Electrocardiography, echocardiography, arterial and venous ultrasound investigation) will be analysed. This study is singlecentral observational trial.
Interventions
DIAGNOSTIC_TESTThe demographic, clinical, laboratory, and instrumental data
Measurement of the demographic, clinical data, laboratory data, and instrumental data
Sponsors
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* all patients with COVID-19 admitted to the ICU with invasive and noninvasive ventilation
Exclusion criteria
* less than 24 hours in ICU by any reason, * chronic decompensated diseases with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure), * atonic coma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical ventilation duration | 30 days | The amount of mechanical ventilation days |
| Non-invasive Mechanical ventilation duration | 30 days | The amount of Non-invasive mechanical ventilation days |
| Mortality | 60 days | The dead and survived patients ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemistry analysis dynamics | Change from baseline on day 15 during ICU treatment | Biochemistry analysis |
| Computer tomography | Change from baseline on day 5 during ICU treatment | Computer tomography of lungs |
| High-sensitive troponin Т | Change from baseline on day 5 during ICU treatment | High-sensitive troponin Т |
| High-sensitive troponin Т dynamics | Change from baseline on day 15 during ICU treatment | High-sensitive troponin Т |
| Biochemistry analysis | Change from baseline on day 5 during ICU treatment | Biochemistry analysis |
| Vitamin D level dynamics | Change from baseline on day 15 during ICU treatment | Vitamin D level |
| Immunogram | Change from baseline on day 5 during ICU treatment | Immunogram |
| Immunogram dynamics | Change from baseline on day 15 during ICU treatment | Immunogram |
| Vitamin D level | Change from baseline on day 5 during ICU treatment | Vitamin D level |
| Сomplete blood count | Change from baseline on day 5 during ICU treatment | Сomplete blood count |
| Сomplete blood count dynamics | Change from baseline on day 15 during ICU treatment | Сomplete blood count |
Countries
Russia
Outcome results
None listed