Clinical Features of Severe Patients With COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Clinical Features of Severe Patients With COVID-19 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
Measurement of the demographic, clinical data, laboratory data, and instrumental data
|
Outcome Measures
Primary Outcome Measures
- 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
- Сomplete blood count [Change from baseline on day 5 during ICU treatment]
Сomplete blood count
- Biochemistry analysis [Change from baseline on day 5 during ICU treatment]
Biochemistry analysis
- Сomplete blood count dynamics [Change from baseline on day 15 during ICU treatment]
Сomplete blood count
- 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
- Vitamin D level [Change from baseline on day 5 during ICU treatment]
Vitamin D level
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Federal Research Clinical Center of Federal Medical & Biological Agency | Moscow | Russian Federation | 115682 |
Sponsors and Collaborators
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Investigators
- Principal Investigator: Tatiana V Klypa, Dr.Med.Sc., Federal Research Clinical Center of Federal Medical & Biological Agency
Study Documents (Full-Text)
None provided.More Information
Publications
- Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Paranjpe I, Russak AJ, De Freitas JK, Lala A, Miotto R, Vaid A, Johnson KW, Danieletto M, Golden E, Meyer D, Singh M, Somani S, Manna S, Nangia U, Kapoor A, O'Hagan R, O'Reilly PF, Huckins LM, Glowe P, Kia A, Timsina P, Freeman RM, Levin MA, Jhang J, Firpo A, Kovatch P, Finkelstein J, Aberg JA, Bagiella E, Horowitz CR, Murphy B, Fayad ZA, Narula J, Nestler EJ, Fuster V, Cordon-Cardo C, Charney DS, Reich DL, Just AC, Bottinger EP, Charney AW, Glicksberg BS, Nadkarni GN. Clinical Characteristics of Hospitalized Covid-19 Patients in New York City. medRxiv. 2020 Apr 26. pii: 2020.04.19.20062117. doi: 10.1101/2020.04.19.20062117.
- Tian W, Jiang W, Yao J, Nicholson CJ, Li RH, Sigurslid HH, Wooster L, Rotter JI, Guo X, Malhotra R. Predictors of mortality in hospitalized COVID-19 patients: A systematic review and meta-analysis. J Med Virol. 2020 Oct;92(10):1875-1883. doi: 10.1002/jmv.26050. Epub 2020 Jul 11.
- COVID-ICU