Clinical Features of Severe Patients With COVID-19

May 19, 2021 updated by: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 115682
        • Federal Research Clinical Center of Federal Medical & Biological Agency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with COVID-19 requiring respiratory support

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-ICU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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