Medical-biological Research of the Pathogenesis of COVID-19 Disease Caused by SARS-CoV-2

Covid19 Clinical Trial

— COV2020  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04611841
• Other study ID #: COV2020
• Status: Enrolling by invitation
• Start date: July 21, 2020
• Est. completion date: December 2022

Study information

• Verified date: October 2020
• Source: Federal Research and Clinical Center of Physical-Chemical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
Russian Federation	Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency	Moscow

Sponsors (6)

Lead Sponsor	Collaborator
Federal Research and Clinical Center of Physical-Chemical Medicine	Burnasyan Federal Medical Biophysical Center, Federal Research Clinical Center of Federal Medical & Biological Agency, Russia, Federal State Budgetary Healthcare Institution, Hospital RAS, Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems, Moscow city hospital named after S.I. Spasokukotskiy

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of antibody binding of patients diagnosed with COVID-19 to proteins of the SARS-CoV-2 virus	Visualization of antibody binding to linear and volumetric sequences SARS-CoV-2 proteins of the virus in 200 samples of blood plasma by the methods Western blot and enzyme-linked immunosorbent assay. It is necessary to identify the epitopes of the SARS-CoV-2 virus recognized by the human immune system and to analyze the individual response of different patients to coronavirus infection.; Sample collection time points: Point 1 - on the day of admission if there is a positive test for RNA virus or on the day of receipt of confirmation of the presence of the virus in an already hospitalized patient; Point 6 - an acute condition, regardless of the day of observation; Point 7 - statement, regardless of the day of observation.	Through samples collection end, an average of 2 years
Primary	Determination of the presence of peptides of the SARS-CoV-2 virus in the plasma of patients diagnosed with COVID-19	Determination of the presence of peptides of the SARS-CoV-2 virus in 100 samples of blood plasma, confirmed by mass spectrometry. It is necessary to identify the correlation between the severity of the coronavirus infection and the presence of viral peptides in the patient's blood; Sample collection time points: Point 1 - on the day of admission if there is a positive test for RNA virus or on the day of receipt of confirmation of the presence of the virus in an already hospitalized patient; Point 6 - an acute condition, regardless of the day of observation; Point 7 - statement, regardless of the day of observation.	Through samples collection end, an average of 2 years
Primary	Determination of the degree of oxidative damage to lipids (lipid peroxidation) in the blood plasma of patients infected with coronavirus	The content of lipid peroxidation products in blood plasma, expressed in µg / ml of plasma.; Analysis 200 samples of blood plasma by spectrophotometric and spectrofluorimetric methods. To demonstrate a statistically significant difference from the control group of patients not infected with coronavirus.; Sample collection time points: Point 1 - on the day of admission if there is a positive test for RNA virus or on the day of receipt of confirmation of the presence of the virus in an already hospitalized patient; Point 6 - an acute condition, regardless of the day of observation; Point 7 - statement, regardless of the day of observation.	Through samples collection end, an average of 2 years
Primary	Revealing the degree of protein damage in the blood plasma of patients infected with coronavirus	The content of average weight molecules in blood plasma, expressed in µg / ml of plasma.; Analysis 200 samples of blood plasma by spectrophotometric method. To demonstrate a statistically significant difference from the control group of patients not infected with coronavirus.; Sample collection time points: Point 1 - on the day of admission if there is a positive test for RNA virus or on the day of receipt of confirmation of the presence of the virus in an already hospitalized patient; Point 6 - an acute condition, regardless of the day of observation; Point 7 - statement, regardless of the day of observation.	Through samples collection end, an average of 2 years
Primary	Measurement of iron (Fe3+) content in blood plasma of patients infected with coronavirus	The content of iron ions (Fe3+) in units of optical density per 1 ml of plasma. Analysis 200 samples of blood plasma by spectrophotometric method. To demonstrate a statistically significant difference from the control group of patients not infected with coronavirus.; Sample collection time points: Point 1 - on the day of admission if there is a positive test for RNA virus or on the day of receipt of confirmation of the presence of the virus in an already hospitalized patient; Point 6 - an acute condition, regardless of the day of observation; Point 7 - statement, regardless of the day of observation.	Through samples collection end, an average of 2 years
Primary	Metagenomic analysis of viral and bacterial respiratory flora of selected samples	500 metagenomes for comparative bioinformatics analysis of viral and bacterial flora in patients with COVID-19 of varying severity.; Sample collection time points: Point 1 - on the day of admission if there is a positive test for RNA virus or on the day of receipt of confirmation of the presence of the virus in an already hospitalized patient; Point 6 - an acute condition, regardless of the day of observation; Point 7 - statement, regardless of the day of observation.	Through samples collection end, an average of 2 years
Primary	Analysis of the genetic variability of the SARS-CoV-2 virus, including the heterogeneity of the viral population in one patient	Bioinformatic analysis of the 500 viral genomes for comparison genetic characteristics of different strains SARS-CoV-2.; Sample collection time points: Point 1 - on the day of admission if there is a positive test for RNA virus or on the day of receipt of confirmation of the presence of the virus in an already hospitalized patient; Point 6 - an acute condition, regardless of the day of observation; Point 7 - statement, regardless of the day of observation.	Through samples collection end, an average of 2 years