Clinical trial NCT04611841: Medical-biological Research of the Pathogenesis of COVID-19 Disease Caused by SARS-CoV-2
Official title: Medical-biological Research of the Pathogenesis of Disease Caused by SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Metavirome
SARS-CoV-2
Pathogenesis
Oxidative stress
Peptides
Lead sponsor: Federal Research and Clinical Center of Physical-Chemical Medicine
Sponsor class: OTHER
Collaborators: name: Burnasyan Federal Medical Biophysical Center
name: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
name: Moscow city hospital named after S.I. Spasokukotskiy
name: Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems
name: Federal State Budgetary Healthcare Institution, Hospital RAS
First posted: 2020-11-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Mostly urban residents, at least 18 years old and no more than 75 years old with clinical manifestations and laboratory confirmed new coronavirus infection.

Brief summary: Сonducting in-depth medical and biological studies of the pathogenesis of the disease caused by the SARS-CoV-2 in Moscow, the Moscow region and some other regions of the Russian Federation.

Detailed description: To date, none of the methods used to test for coronavirus infection provide reliable information about the status of an individual's infection. Common tests based on PCR, carried out on the basis of samples taken from the human respiratory tract, give a positive answer in far from all cases. Antibody tests may not record the initial stages of the disease, or may not reveal residual immunity in those who have been ill, while giving cross-reactions to other common coronaviruses.

A comprehensive assessment of the biological parameters of the virus and the parameters of the immune response to infection is required. In this regard, we propose an integrated approach, including the use of PCR testing technology, analysis of the immune response in the form of antibodies of all major classes (IgG, IgA), determination of inflammation markers, C-reactive protein, detailed blood test, ferritin and troponin.

In addition, an analysis of the genetic diversity of strains of the pathogen COVID-19 circulating among various groups of the population of the Russian Federation will be carried out.

To collect and analyze data, it is planned to enter information into a special electronic system and analyze the collected data with a wide range of informative methods that allow "layer by layer" to compare and collect a complete picture of what is happening.

Objectives of the study:

1. Identifying the percentage of infected in the population in Moscow, the Moscow region and some other regions where the epidemic situation in connection with SARS-CoV-2 remains tense;
2. Study of genetic diversity (including metavirome) and dynamics of structural variability of the causative agent of coronavirus infection in the studied regions;
3. Studying the features of the formation and tension of immunity in patients who have undergone coronavirus infection of varying severity;
4. Clarification of the mechanisms of occurrence and development of coronavirus infection.

In the study of biological samples obtained from research participants, methods of proteomics, peptidomics, next generation sequencing (NGS), physicochemical methods of analysis will be used.

Eligibility criteria: Inclusion Criteria:

* Age over 18 and under 75 years old
* COVID-19 diagnosis confirmed by PCR test
* Written consent to participate in the study

Exclusion Criteria:

* Unwillingness or inability to give written informed consent to participate in the study
* A serious condition with a threat to life or contraindications that prevent the collection of biomaterial
* Oncological diseases outside the stage of remission

Primary outcomes:
measure: Determination of antibody binding of patients diagnosed with COVID-19 to proteins of the SARS-CoV-2 virus
timeFrame: Through samples collection end, an average of 2 years
measure: Determination of the presence of peptides of the SARS-CoV-2 virus in the plasma of patients diagnosed with COVID-19
timeFrame: Through samples collection end, an average of 2 years
measure: Determination of the degree of oxidative damage to lipids (lipid peroxidation) in the blood plasma of patients infected with coronavirus
timeFrame: Through samples collection end, an average of 2 years
measure: Revealing the degree of protein damage in the blood plasma of patients infected with coronavirus
timeFrame: Through samples collection end, an average of 2 years
measure: Measurement of iron (Fe3+) content in blood plasma of patients infected with coronavirus
timeFrame: Through samples collection end, an average of 2 years
measure: Metagenomic analysis of viral and bacterial respiratory flora of selected samples
timeFrame: Through samples collection end, an average of 2 years
measure: Analysis of the genetic variability of the SARS-CoV-2 virus, including the heterogeneity of the viral population in one patient
timeFrame: Through samples collection end, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency
Study officials:
affiliation: FRCC PCM
name: Vadim Govorun, MD
role: STUDY_DIRECTOR
References: