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NCT Number: NCT04450017

Clinical Features of Severe Patients With COVID-19

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.

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Key information

Conditions

Sars-CoV2 COVID-19 Coronaviridae Infections Coronavirus Infections Disease Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal Research Clinical Center of Federal Medical & Biological Agency

Moscow, 115682, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The demographic, clinical, laboratory, and instrumental data

Diagnostic Test

Measurement of the demographic, clinical data, laboratory data, and instrumental data

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 29, 2020
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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