Clinical Features of Severe Patients With COVID-19

Study Overview
=================
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.

Official Title
-----------------
Clinical Features of Severe Patients With COVID-19

Conditions
-----------------
SARS-CoV2

Intervention / Treatment
-----------------
* Diagnostic Test: The demographic, clinical, laboratory, and instrumental data


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical Features of Severe Patients With COVID-19<br>Critical ill patients with COVID-19 admitted to the ICU. The demographic, clinical data, laboratory data, and Instrumental data will be analysed. | Diagnostic Test: The demographic, clinical, laboratory, and instrumental data<br>* Measurement of the demographic, clinical data, laboratory data, and instrumental data<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation duration | The amount of mechanical ventilation days | 30 days | 
| Non-invasive Mechanical ventilation duration | The amount of Non-invasive mechanical ventilation days | 30 days | 
| Mortality | The dead and survived patients ratio | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Сomplete blood count | Сomplete blood count | Change from baseline on day 5 during ICU treatment | 
| Biochemistry analysis | Biochemistry analysis | Change from baseline on day 5 during ICU treatment | 
| Сomplete blood count dynamics | Сomplete blood count | Change from baseline on day 15 during ICU treatment | 
| Biochemistry analysis dynamics | Biochemistry analysis | Change from baseline on day 15 during ICU treatment | 
| Computer tomography | Computer tomography of lungs | Change from baseline on day 5 during ICU treatment | 
| High-sensitive troponin Т | High-sensitive troponin Т | Change from baseline on day 5 during ICU treatment | 
| High-sensitive troponin Т dynamics | High-sensitive troponin Т | Change from baseline on day 15 during ICU treatment | 
| Vitamin D level | Vitamin D level | Change from baseline on day 5 during ICU treatment | 
| Vitamin D level dynamics | Vitamin D level | Change from baseline on day 15 during ICU treatment | 
| Immunogram | Immunogram | Change from baseline on day 5 during ICU treatment | 
| Immunogram dynamics | Immunogram | Change from baseline on day 15 during ICU treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS pneumonia, COVID-19, severe disease, risk factors