Clinical Features of Severe Patients With COVID-19
- Conditions
- SARS-CoV2
- Interventions
- Diagnostic Test: The demographic, clinical, laboratory, and instrumental data
- Registration Number
- NCT04450017
- Lead Sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- all patients with COVID-19 admitted to the ICU with invasive and noninvasive ventilation
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Clinical Features of Severe Patients With COVID-19 The demographic, clinical, laboratory, and instrumental data Critical ill patients with COVID-19 admitted to the ICU. The demographic, clinical data, laboratory data, and Instrumental data will be analysed.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Сomplete blood count dynamics Change from baseline on day 15 during ICU treatment Сomplete blood count
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 dynamics Change from baseline on day 15 during ICU treatment Immunogram
Сomplete blood count Change from baseline on day 5 during ICU treatment Сomplete blood count
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
Immunogram Change from baseline on day 5 during ICU treatment Immunogram
Biochemistry analysis dynamics Change from baseline on day 15 during ICU treatment Biochemistry analysis
Vitamin D level Change from baseline on day 5 during ICU treatment Vitamin D level
High-sensitive troponin Т dynamics Change from baseline on day 15 during ICU treatment High-sensitive troponin Т
Trial Locations
- Locations (1)
Federal Research Clinical Center of Federal Medical & Biological Agency
🇷🇺Moscow, Russian Federation