Covid19COV2020NCT04611841
Medical-biological Research of the Pathogenesis of COVID-19 Disease Caused by SARS-CoV-2
An observational study of Covid19, run by Federal Research and Clinical Center of Physical-Chemical Medicine at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19
- How many people
- 250 participants
- Where
- 1 siteRussia
- Study dates
- 21 Jul 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age over 18 and under 75 years old
- COVID-19 diagnosis confirmed by PCR test
- Written consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency
Moscow
About this study
Official title: Medical-biological Research of the Pathogenesis of Disease Caused by SARS-CoV-2
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.
Read the 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:
- 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;
- Study of genetic diversity (including metavirome) and dynamics of structural variability of the causative agent of coronavirus infection in the studied regions;
- Studying the features of the formation and tension of immunity in patients who have undergone coronavirus infection of varying severity;
- 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.
- Conditions
- Covid19
- Keywords
- Metavirome, SARS-CoV-2, Pathogenesis, Oxidative stress, Peptides
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through samples collection end, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start21 Jul 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research and Clinical Center of Physical-Chemical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Burnasyan Federal Medical Biophysical Center, Federal Research Clinical Center of Federal Medical & Biological Agency, Russia, Moscow city hospital named after S.I. Spasokukotskiy, Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems, Federal State Budgetary Healthcare Institution, Hospital RAS
- Responsible party
- Sponsor
- Investigators
- Vadim Govorun, MD, Study director, FRCC PCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611841
- Sponsor's protocol ID
- COV2020
- Acronym
- COV2020
- Status last verified
- Oct 2020
- First submitted
- 26 Sep 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical-biological Research of the Pathogenesis of Disease Caused by SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04611841
- Acronym / sponsor ID
- COV2020 / COV2020
- Conditions
- Covid19
- Keywords
- Metavirome, SARS-CoV-2, Pathogenesis, Oxidative stress, Peptides
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Federal Research and Clinical Center of Physical-Chemical MedicineUniversity, hospital or other
- Collaborators
- Burnasyan Federal Medical Biophysical Center, Federal Research Clinical Center of Federal Medical & Biological Agency, Russia, Moscow city hospital named after S.I. Spasokukotskiy, Federal State Public Scientific Institution, Scientific Center for Family Health and Human Reproduction Problems, Federal State Budgetary Healthcare Institution, Hospital RAS
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- Study of genetic diversity (including metavirome) and dynamics of structural variability of the causative agent of coronavirus infection in the studied regions;
- Studying the features of the formation and tension of immunity in patients who have undergone coronavirus infection of varying severity;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age over 18 and under 75 years old
- COVID-19 diagnosis confirmed by PCR test
- Written consent to participate in the study
Key exclusion criteria (3 listed)
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of antibody binding of patients diagnosed with COVID-19 to proteins of the SARS-CoV-2 virus
Time frame: Through samples collection end, an average of 2 years
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.
Determination of the presence of peptides of the SARS-CoV-2 virus in the plasma of patients diagnosed with COVID-19
Time frame: Through samples collection end, an average of 2 years
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.
Determination of the degree of oxidative damage to lipids (lipid peroxidation) in the blood plasma of patients infected with coronavirus
Time frame: Through samples collection end, an average of 2 years
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.
Revealing the degree of protein damage in the blood plasma of patients infected with coronavirus
Time frame: Through samples collection end, an average of 2 years
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.
Measurement of iron (Fe3+) content in blood plasma of patients infected with coronavirus
Time frame: Through samples collection end, an average of 2 years
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.
Metagenomic analysis of viral and bacterial respiratory flora of selected samples
Time frame: Through samples collection end, an average of 2 years
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.
Analysis of the genetic variability of the SARS-CoV-2 virus, including the heterogeneity of the viral population in one patient
Time frame: Through samples collection end, an average of 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vadim Govorun, MD study director
FRCC PCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Federal Research and Clinical Center of Physical-Chemical Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of antibody binding of patients diagnosed with COVID-19 to proteins of the SARS-CoV-2 virus (time frame: Through samples collection end, an average of 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.