Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Features of Severe Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450017
Recruitment Status : Completed
First Posted : June 29, 2020
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
SARS-CoV2 Diagnostic Test: The demographic, clinical, laboratory, and instrumental data

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Features of Severe Patients With COVID-19
Actual Study Start Date : April 6, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Group/Cohort 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




Primary Outcome Measures :
  1. Mechanical ventilation duration [ Time Frame: 30 days ]
    The amount of mechanical ventilation days

  2. Non-invasive Mechanical ventilation duration [ Time Frame: 30 days ]
    The amount of Non-invasive mechanical ventilation days

  3. Mortality [ Time Frame: 60 days ]
    The dead and survived patients ratio


Secondary Outcome Measures :
  1. Сomplete blood count [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    Сomplete blood count

  2. Biochemistry analysis [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    Biochemistry analysis

  3. Сomplete blood count dynamics [ Time Frame: Change from baseline on day 15 during ICU treatment ]
    Сomplete blood count

  4. Biochemistry analysis dynamics [ Time Frame: Change from baseline on day 15 during ICU treatment ]
    Biochemistry analysis

  5. Computer tomography [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    Computer tomography of lungs

  6. High-sensitive troponin Т [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    High-sensitive troponin Т

  7. High-sensitive troponin Т dynamics [ Time Frame: Change from baseline on day 15 during ICU treatment ]
    High-sensitive troponin Т

  8. Vitamin D level [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    Vitamin D level

  9. Vitamin D level dynamics [ Time Frame: Change from baseline on day 15 during ICU treatment ]
    Vitamin D level

  10. Immunogram [ Time Frame: Change from baseline on day 5 during ICU treatment ]
    Immunogram

  11. Immunogram dynamics [ Time Frame: Change from baseline on day 15 during ICU treatment ]
    Immunogram



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with COVID-19 requiring respiratory support
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450017


Locations
Layout table for location information
Russian Federation
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
Layout table for investigator information
Principal Investigator: Tatiana V Klypa, Dr.Med.Sc. Federal Research Clinical Center of Federal Medical & Biological Agency
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
ClinicalTrials.gov Identifier: NCT04450017    
Other Study ID Numbers: COVID-ICU
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia:
SARS pneumonia
COVID-19
severe disease
risk factors
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases