Clinical, Functional, Immunological and Genetic Factors on the Severity of the Course of Coronavirus Infection
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
2 other identifiers
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedAugust 3, 2021
July 1, 2021
1.5 years
July 23, 2021
July 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
bioinformatic data analysis
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
24 months
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
24 months
Study Arms (3)
Acute COVID patients
Patients in the acute phase of the course of the disease
Long Covid Patients
Patients with chronic symptoms after a previous Covid-19 (4-12 weeks)
Postcovid patients
Patients with chronic symptoms after a previous Covid-19 (more than 12 weeks)
Interventions
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
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).
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
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Refusal to undergo diagnostic procedures determined by the research protocol.
- Evidence for preexisting interstitial lung disease.
- Participation in another study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Research Center for Cardiac Surgery
Astana, 010000, Kazakhstan
Related Publications (17)
Soy M, Keser G, Atagunduz P, Tabak F, Atagunduz I, Kayhan S. Cytokine storm in COVID-19: pathogenesis and overview of anti-inflammatory agents used in treatment. Clin Rheumatol. 2020 Jul;39(7):2085-2094. doi: 10.1007/s10067-020-05190-5. Epub 2020 May 30.
PMID: 32474885BACKGROUNDZhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. Addendum: A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Dec;588(7836):E6. doi: 10.1038/s41586-020-2951-z. No abstract available.
PMID: 33199918RESULTde Wit E, van Doremalen N, Falzarano D, Munster VJ. SARS and MERS: recent insights into emerging coronaviruses. Nat Rev Microbiol. 2016 Aug;14(8):523-34. doi: 10.1038/nrmicro.2016.81. Epub 2016 Jun 27.
PMID: 27344959RESULTHuang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PMID: 31986264RESULTRagab D, Salah Eldin H, Taeimah M, Khattab R, Salem R. The COVID-19 Cytokine Storm; What We Know So Far. Front Immunol. 2020 Jun 16;11:1446. doi: 10.3389/fimmu.2020.01446. eCollection 2020.
PMID: 32612617RESULTVabret N, Britton GJ, Gruber C, Hegde S, Kim J, Kuksin M, Levantovsky R, Malle L, Moreira A, Park MD, Pia L, Risson E, Saffern M, Salome B, Esai Selvan M, Spindler MP, Tan J, van der Heide V, Gregory JK, Alexandropoulos K, Bhardwaj N, Brown BD, Greenbaum B, Gumus ZH, Homann D, Horowitz A, Kamphorst AO, Curotto de Lafaille MA, Mehandru S, Merad M, Samstein RM; Sinai Immunology Review Project. Immunology of COVID-19: Current State of the Science. Immunity. 2020 Jun 16;52(6):910-941. doi: 10.1016/j.immuni.2020.05.002. Epub 2020 May 6.
PMID: 32505227RESULTLiu J, Wu P, Gao F, Qi J, Kawana-Tachikawa A, Xie J, Vavricka CJ, Iwamoto A, Li T, Gao GF. Novel immunodominant peptide presentation strategy: a featured HLA-A*2402-restricted cytotoxic T-lymphocyte epitope stabilized by intrachain hydrogen bonds from severe acute respiratory syndrome coronavirus nucleocapsid protein. J Virol. 2010 Nov;84(22):11849-57. doi: 10.1128/JVI.01464-10. Epub 2010 Sep 15.
PMID: 20844028RESULTHenderson LA, Canna SW, Schulert GS, Volpi S, Lee PY, Kernan KF, Caricchio R, Mahmud S, Hazen MM, Halyabar O, Hoyt KJ, Han J, Grom AA, Gattorno M, Ravelli A, De Benedetti F, Behrens EM, Cron RQ, Nigrovic PA. On the Alert for Cytokine Storm: Immunopathology in COVID-19. Arthritis Rheumatol. 2020 Jul;72(7):1059-1063. doi: 10.1002/art.41285. Epub 2020 May 10.
PMID: 32293098RESULTXie X, Zhong Z, Zhao W, Zheng C, Wang F, Liu J. Chest CT for Typical Coronavirus Disease 2019 (COVID-19) Pneumonia: Relationship to Negative RT-PCR Testing. Radiology. 2020 Aug;296(2):E41-E45. doi: 10.1148/radiol.2020200343. Epub 2020 Feb 12.
PMID: 32049601RESULTAi T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.
PMID: 32101510RESULTWu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PMID: 32091533RESULTLi X, Geng M, Peng Y, Meng L, Lu S. Molecular immune pathogenesis and diagnosis of COVID-19. J Pharm Anal. 2020 Apr;10(2):102-108. doi: 10.1016/j.jpha.2020.03.001. Epub 2020 Mar 5.
PMID: 32282863RESULTLu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W. Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020 Feb 22;395(10224):565-574. doi: 10.1016/S0140-6736(20)30251-8. Epub 2020 Jan 30.
PMID: 32007145RESULTHalpin S, O'Connor R, Sivan M. Long COVID and chronic COVID syndromes. J Med Virol. 2021 Mar;93(3):1242-1243. doi: 10.1002/jmv.26587. Epub 2020 Oct 30. No abstract available.
PMID: 33034893RESULTMendelson M, Nel J, Blumberg L, Madhi SA, Dryden M, Stevens W, Venter FWD. Long-COVID: An evolving problem with an extensive impact. S Afr Med J. 2020 Nov 23;111(1):10-12. doi: 10.7196/SAMJ.2020.v111i11.15433.
PMID: 33403997RESULTVink M, Vink-Niese A. Could Cognitive Behavioural Therapy Be an Effective Treatment for Long COVID and Post COVID-19 Fatigue Syndrome? Lessons from the Qure Study for Q-Fever Fatigue Syndrome. Healthcare (Basel). 2020 Dec 11;8(4):552. doi: 10.3390/healthcare8040552.
PMID: 33322316RESULTBekbossynova M, Tauekelova A, Kalila Z, Sailybayeva A, Khamitov S, Oralbekova Z. Anxiety and Depression Among Astana Reinfected Patients at 1-, 3-, and 6-Month Follow-Up in the Post-COVID Center. Can Respir J. 2025 Feb 24;2025:5596465. doi: 10.1155/carj/5596465. eCollection 2025.
PMID: 40041615DERIVED
Related Links
Biospecimen
1. blood 2. deoxyribonucleic acid (DNA) samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Makhabbat Sansyzbaeva
Chairman of the Board of "National Research Cardiac Surgery Centre" JSC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman of the Board
Study Record Dates
First Submitted
July 23, 2021
First Posted
August 3, 2021
Study Start
June 1, 2021
Primary Completion
December 1, 2022
Study Completion
June 1, 2023
Last Updated
August 3, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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
all IPD that underlie results in a publication