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Clinical, Functional, Immunological and Genetic Factors on the Severity of the Course of Coronavirus Infection

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04987853
Recruitment Status : Recruiting
First Posted : August 3, 2021
Last Update Posted : August 3, 2021
Sponsor:
Collaborator:
Nazarbayev University Medical Center
Information provided by (Responsible Party):
Makhabbat Bekbossynova, National Research Center for Cardiac Surgery, Kazakhstan

Brief Summary:
The purpose of the program. To determine the clinical, functional, immunological, and genetic factors affecting the severity of the course of acute coronavirus infection COVID-19 and PostCovid syndrome, in order to develop management tactics for such patients to reduce the risk of complications and disability.

Condition or disease Intervention/treatment
Covid19 Corona Virus Infection Diagnostic Test: Clinical and functional analysis Diagnostic Test: Neurological analysis Diagnostic Test: Immunological analysis: Diagnostic Test: Genetic analysis:

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Influence of Clinical, Functional, Immunological, and Genetic Factors on the Severity of the Course of Coronavirus Infection With SARS-CoV-2 and Post Covid Syndrome
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Acute COVID patients
Patients in the acute phase of the course of the disease
Diagnostic Test: Clinical and functional analysis

General blood analysis - Complete blood count on an analyzer with differentiation of 5 classes of cells, the ratio of neutrophils to lymphocytes; Blood chemistry - ALT, AST, total bilirubin, direct, LDH, CRP, alpha-amylase, creatinine, urea, glucose, ferritin, glycosylated hemoglobin, vitamin 25 - OH vitamin D, vitamin B12; Coagulogram - D-dimers, fibrinogen, INR, APTT; Other - NT-pro BNP, Homocysteine, IL 6, Troponin, blood group determination; Linked immunosorbent assay - Determination of IgG and IgM antibodies to SARS-CoV-2 coronavirus (COVID-19) in blood serum, RBD; Functional diagnostics • ECG

  • EchoCG + strain
  • CT scan of the lungs
  • Holter
  • SMAD
  • Kidney ultrasound
  • Ultrasound
  • Doppler ultrasonography of veins and arteries
  • Chalder Scale, EQ Questionnaire
Other Names:
  • Immunological analysis
  • Genetic analysis

Diagnostic Test: Neurological analysis

Neurological examination with the isolation of neurological syndromes (motor, cognitive impairments, sleep disorders, asthenic-depressive syndromes, etc.).

2. Neuropsychological methods - research on the scales of anxiety and depression, MMSE, etc.

3. Instrumental method - EEG, polysonography, ultrasound of the neck vessels, CT perfusion.

4. Laboratory research methods:

  1. The study of antibodies to some neurospecific antigens - myelin basic protein (MBP), neurospecific enolase (NSE).
  2. Study of cellular immunity (CD3 +, CD4 +, CD8 +) and general indicators of humoral immunity (IgG, IgA, IgM, circulating immune complexes).

Diagnostic Test: Immunological analysis:
A comprehensive immunological analysis will be carried out to determine the level of the immune response. Calculation of the level of CD4 +, CD8 + and NK cells. The level of antibodies of the IgG and IgM classes to the proteins of the coronavirus S1, RBD and N was determined
Other Names:
  • Multiplex Immunoassay
  • Immunophenotyping of T-cell and B-cell subpopulations

Diagnostic Test: Genetic analysis:
Isolation (extraction) of DNA will be performed from whole blood using commercial kits according to the manufacturer's instructions. To analyze a large number of genetic markers, it is planned to carry out genome-wide sequencing followed by analysis of genetic polymorphisms of candidate genes encoding coronavirus receptors and immunological factors.

Long Covid Patients
Patients with chronic symptoms after a previous Covid-19 (4-12 weeks)
Diagnostic Test: Clinical and functional analysis

General blood analysis - Complete blood count on an analyzer with differentiation of 5 classes of cells, the ratio of neutrophils to lymphocytes; Blood chemistry - ALT, AST, total bilirubin, direct, LDH, CRP, alpha-amylase, creatinine, urea, glucose, ferritin, glycosylated hemoglobin, vitamin 25 - OH vitamin D, vitamin B12; Coagulogram - D-dimers, fibrinogen, INR, APTT; Other - NT-pro BNP, Homocysteine, IL 6, Troponin, blood group determination; Linked immunosorbent assay - Determination of IgG and IgM antibodies to SARS-CoV-2 coronavirus (COVID-19) in blood serum, RBD; Functional diagnostics • ECG

  • EchoCG + strain
  • CT scan of the lungs
  • Holter
  • SMAD
  • Kidney ultrasound
  • Ultrasound
  • Doppler ultrasonography of veins and arteries
  • Chalder Scale, EQ Questionnaire
Other Names:
  • Immunological analysis
  • Genetic analysis

Diagnostic Test: Neurological analysis

Neurological examination with the isolation of neurological syndromes (motor, cognitive impairments, sleep disorders, asthenic-depressive syndromes, etc.).

2. Neuropsychological methods - research on the scales of anxiety and depression, MMSE, etc.

3. Instrumental method - EEG, polysonography, ultrasound of the neck vessels, CT perfusion.

4. Laboratory research methods:

  1. The study of antibodies to some neurospecific antigens - myelin basic protein (MBP), neurospecific enolase (NSE).
  2. Study of cellular immunity (CD3 +, CD4 +, CD8 +) and general indicators of humoral immunity (IgG, IgA, IgM, circulating immune complexes).

Diagnostic Test: Immunological analysis:
A comprehensive immunological analysis will be carried out to determine the level of the immune response. Calculation of the level of CD4 +, CD8 + and NK cells. The level of antibodies of the IgG and IgM classes to the proteins of the coronavirus S1, RBD and N was determined
Other Names:
  • Multiplex Immunoassay
  • Immunophenotyping of T-cell and B-cell subpopulations

Diagnostic Test: Genetic analysis:
Isolation (extraction) of DNA will be performed from whole blood using commercial kits according to the manufacturer's instructions. To analyze a large number of genetic markers, it is planned to carry out genome-wide sequencing followed by analysis of genetic polymorphisms of candidate genes encoding coronavirus receptors and immunological factors.

Postcovid patients
Patients with chronic symptoms after a previous Covid-19 (more than 12 weeks)
Diagnostic Test: Clinical and functional analysis

General blood analysis - Complete blood count on an analyzer with differentiation of 5 classes of cells, the ratio of neutrophils to lymphocytes; Blood chemistry - ALT, AST, total bilirubin, direct, LDH, CRP, alpha-amylase, creatinine, urea, glucose, ferritin, glycosylated hemoglobin, vitamin 25 - OH vitamin D, vitamin B12; Coagulogram - D-dimers, fibrinogen, INR, APTT; Other - NT-pro BNP, Homocysteine, IL 6, Troponin, blood group determination; Linked immunosorbent assay - Determination of IgG and IgM antibodies to SARS-CoV-2 coronavirus (COVID-19) in blood serum, RBD; Functional diagnostics • ECG

  • EchoCG + strain
  • CT scan of the lungs
  • Holter
  • SMAD
  • Kidney ultrasound
  • Ultrasound
  • Doppler ultrasonography of veins and arteries
  • Chalder Scale, EQ Questionnaire
Other Names:
  • Immunological analysis
  • Genetic analysis

Diagnostic Test: Neurological analysis

Neurological examination with the isolation of neurological syndromes (motor, cognitive impairments, sleep disorders, asthenic-depressive syndromes, etc.).

2. Neuropsychological methods - research on the scales of anxiety and depression, MMSE, etc.

3. Instrumental method - EEG, polysonography, ultrasound of the neck vessels, CT perfusion.

4. Laboratory research methods:

  1. The study of antibodies to some neurospecific antigens - myelin basic protein (MBP), neurospecific enolase (NSE).
  2. Study of cellular immunity (CD3 +, CD4 +, CD8 +) and general indicators of humoral immunity (IgG, IgA, IgM, circulating immune complexes).

Diagnostic Test: Immunological analysis:
A comprehensive immunological analysis will be carried out to determine the level of the immune response. Calculation of the level of CD4 +, CD8 + and NK cells. The level of antibodies of the IgG and IgM classes to the proteins of the coronavirus S1, RBD and N was determined
Other Names:
  • Multiplex Immunoassay
  • Immunophenotyping of T-cell and B-cell subpopulations

Diagnostic Test: Genetic analysis:
Isolation (extraction) of DNA will be performed from whole blood using commercial kits according to the manufacturer's instructions. To analyze a large number of genetic markers, it is planned to carry out genome-wide sequencing followed by analysis of genetic polymorphisms of candidate genes encoding coronavirus receptors and immunological factors.




Primary Outcome Measures :
  1. bioinformatic data analysis [ Time Frame: 24 months ]
    To analyze a large number of genetic markers, it is planned to carry out genome-wide sequencing followed by analysis of genetic polymorphisms of candidate genes encoding coronavirus receptors and immunological factors

  2. the level of the immune response [ Time Frame: 24 months ]
    Calculation of the level of CD4 +, CD8 + and NK cells. The level of antibodies of the IgG and IgM classes to the proteins of the coronavirus S1, RBD and N was determined


Biospecimen Retention:   Samples With DNA
  1. blood
  2. deoxyribonucleic acid (DNA) samples


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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will include patients with a positive PCR test for COVID-19. Patients in the acute phase of the course of the disease are monitored and treated in accordance with the republican COVID-19 treatment protocol. After signing the informed consent, the patient will be included in the study. The collection of the necessary materials for subsequent analyzes (clinical-functional, genetic, immunological) will be carried out in accordance with this protocol. Subsequently, patients are observed within one year from the moment of illness in accordance with the study protocol and with the collection of all necessary materials.
Criteria

Inclusion Criteria:

  • Age over 18 years old
  • Patients with a history of coronavirus infection COVID-19 confirmed by PCR analysis
  • Patients who signed informed consent to participate in the study

Exclusion Criteria:

  • Refusal to undergo diagnostic procedures determined by the research protocol.
  • Evidence for preexisting interstitial lung disease.
  • Participation in another study.

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): NCT04987853


Contacts
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Contact: Makhabbat Sansyzbaeva, PhD, MD +77055965060 ext +77172703153 cardiacsurgeryres@gmail.com
Contact: Ainur Tauekelova, MD +7 (7172) 703 158 ainuratau@mail.ru

Locations
Layout table for location information
Kazakhstan
National Research Center for Cardiac Surgery Recruiting
Astana, Kazakhstan, 010000
Contact: Makhabbat Sansyzbaeva, PhD, MD    +77172703153    cardiacsurgeryres@gmail.com   
Sponsors and Collaborators
National Research Center for Cardiac Surgery, Kazakhstan
Nazarbayev University Medical Center
Investigators
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Principal Investigator: Makhabbat Sansyzbaeva Chairman of the Board of "National Research Cardiac Surgery Centre" JSC
  Study Documents (Full-Text)

Documents provided by Makhabbat Bekbossynova, National Research Center for Cardiac Surgery, Kazakhstan:
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: BR10965164
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: BR10965164
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: BR10965164

Publications of Results:

Other Publications:
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Responsible Party: Makhabbat Bekbossynova, Chairman of the Board, National Research Center for Cardiac Surgery, Kazakhstan
ClinicalTrials.gov Identifier: NCT04987853    
Other Study ID Numbers: version 1.0
BR10965164 ( Other Grant/Funding Number: MES RK )
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: starting 6 months after publication
Access Criteria: all types of supporting information will be shared with the interested party within the framework of the legislation of the Republic of Kazakhstan
URL: http://heartcenter.kz

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Makhabbat Bekbossynova, National Research Center for Cardiac Surgery, Kazakhstan:
Post Covid syndrome
pneumonia
cardiology
genetic research
immunology
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Coronavirus Infections
Disease Attributes
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases