Official Title
Medical-biological Research of the Pathogenesis of Disease Caused by SARS-CoV-2
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.

Unknown status
COVID19
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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Russian Federation
Locations

Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency
Moscow, Russian Federation

Vadim Govorun, MD, Study Director
FRCC PCM

Federal Research and Clinical Center of Physical-Chemical Medicine
NCT Number
Keywords
Metavirome
SARS-CoV-2
Pathogenesis
Oxidative stress
Peptides
MeSH Terms
COVID-19