An observational study in COVID-19, SARS-CoV-2 and Furin, sponsored by Center Trials & Treatment. Terminated at 9 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Center Trials & Treatment · Observational
The rapid spread of SARS-CoV-2 (also known as 2019-nCoV and HCoV-19 1), a novel beta coronavirus B lineage (βCoV), has sparked a global coronavirus disease (COVID-19) pandemic. It has been suggested that RRAR, a unique furin-like cleavage site (FCS) in the spike protein (S) that is absent in other B βCoV lines such as SARS-CoV, is responsible for its high infectivity and transmissibility.
Furin is a protein with a special function of a fermentative biocatalyst: which recognizes the degree of maturity of a group of amino acids Functionally, Furin works to renew the body, but it is also a path to the introduction of the SARS-CoV virus into a living human cell, HIV virus, Ebola virus, and others that penetrate a human cell using the Furin protein, sending a conditioned signal from the extracellular matrix, and gives the virus the opportunity to merge the protein of the coronavirus spike and the protein content of the cut cell, which activates the phase of virus replication in the body.
We hypothesize that measuring the quantitative indicators of Furin protein expression in patients (at the onset of the disease) who have recovered from SARS-CoV-2 and vaccinated (with all types of vaccines) against coronavirus can provide an understanding of the molecular-cellular mechanisms of the virus's cellular invasion. This means that it will be possible to find new ways to prevent the fusion of the membranes of infected cells with normal ones (this mechanism allows the virus to spread throughout the body without leaving the affected cells).
Protein identification will be carried out by Enhanced Chemiluminescence (ECL) (the method of enhanced chemiluminescence differs from the method of immunochemical staining using chromogenic substrates by a much greater sensitivity)
The parameters of the Furin protein in the blood of patients with a confirmed diagnosis of COVID-19 on days 4, 8, or 14 after the onset of symptoms of the disease or a positive PCR test will be assessed ( provided they are in a hospital or clinic for inpatient or outpatient treatment).
The presence of specific antibodies in the blood serum allows you to determine whether the body has met with the COVID-19 virus and whether antibodies have been developed during the contact that recognizes] this virus when they meet again. ⠀ The primary immune response to antigens new to the body begins with the production of immunoglobulins M (IgM). IgM to COVID-19 appears in the blood about 2-3 weeks after exposure to the virus in the case of asymptomatic COVID-19 and disappears by about 14-16 weeks.
Since the formation of antibodies is due to the individual characteristics of the immune system, the results of selective testing on different test systems in different countries in different ethnic groups should verify the result.
* The absence of antibodies will not be evidence of the absence of infection, since there is a concept of a "serological window", when the pathogen has already entered the body, the pathological process develops, but antibodies have not yet appeared.
Age data will be taken into account This study does not imply the receipt, storage and processing of personal data.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 2,432 is above the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →Center Trials & Treatment is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Determination of the level of Furin protein in the blood of patients with confirmed SARS-CoV2 and being treated in a hospital
Determination of the level of Furin protein in the blood of patients with confirmed SARS-CoV2 and being treated in a hospital
Time frame: up to 12 month
Determination of the level of Furin protein in the blood of patients with confirmed SARS-CoV2 and who are on outpatient treatment
Determination of the level of Furin protein in the blood of patients with confirmed SARS-CoV2 and who are on outpatient treatment
Time frame: up to 12 month
Determination of the level of furin protein in the blood of those vaccinated against SARS-CoV2 after the first and second vaccinations (or after the ones-dose vaccine J&J)
Determination of the level of furin protein in the blood of those vaccinated against SARS-CoV2 after the first and second vaccinations (or after the ones-dose vaccine J\&J)
Time frame: up to 12 month
determination of the levels of antibodies (IgG, IgM) to the proteins (nucleocapsid (N) and the RBD S-protein site) SARS-CoV-2 in patients with test positive for COVID-19
determination of the levels of antibodies (IgG, IgM) to the IgG class coronavirus, to the spike protein (S) SARS-CoV-2 and IgM antibodies, to the proteins (nucleocapsid (N) and the RBD S-protein site) SARS-CoV-2 in patients with test positive for COVID-19
Time frame: up to 12 month
determination of the levels of antibodies (IgG, IgM) to the proteins (nucleocapsid (N) and the RBD S-protein site) SARS-CoV-2 in vaccinated against coronavirus disease (randomized sample by type of vaccine)
determination of the levels of antibodies (IgG, IgM) to the IgG class coronavirus, to the spike protein (S) SARS-CoV-2 and IgM antibodies, to the proteins (nucleocapsid (N) and the RBD S-protein site) SARS-CoV-2 in vaccinated against coronavirus disease (randomized sample by type of vaccine)
Time frame: up to 12 month
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: after the end of the research
Ran from Aug 2022 to primary completion in Mar 2023, 7 months.
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This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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