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

NCT04611841 | Unknown

• 1 other identifier: COV2020
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Metavirome; SARS-CoV-2; Pathogenesis; Oxidative stress; Peptides

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency

Moscow, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vadim Govorun, MD

  FRCC PCM

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2020
• First Posted: November 2, 2020
• Study Start: July 21, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 2, 2020

Record last verified: 2020-10

Locations

RU (1)