Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05104840 |
| Other study ID # |
6564N20-20 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 10, 2022 |
| Est. completion date |
March 28, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Center Trials & Treatment |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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)
Description:
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).
- Patients will be asked to donate blood for an enzyme-linked immunosorbent assay of
levels of specific IgM and IgG to SARS-CoV-2 from the 3rd to the 39th day after the
development of COVID-19 (provided they are in a hospital or clinic for inpatient or
outpatient treatment)
- Patients will be asked to take a blood test to quantify antibodies (IgG, IgM) to the IgG
class coronavirus to the SARS-CoV-2 spike (S) protein and IgM antibodies, to proteins
(nucleocapsid (N) and RBD site of the S-protein ) SARS-CoV-2, (ELISA),
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.
- In the vaccinated, the level of Furin protein in the blood will be determined after the
first and (or) after the second vaccination, as well as after the booster dose on days
10-60-120-240-360 after vaccination.
- In those who have been ill, but not vaccinated with any vaccine against coronavirus, the
level of Furin protein in the blood will be determined up to 60 days after receiving a
negative PCR test and the absence of clinical signs of the disease.
- In patients with post-COVID conditions (syndrome), or with a severe form of the disease,
the indicators will be determined up to day 180 inclusive after receiving a negative PCR
test and the absence of acute clinical signs of the disease.
- If the patients have data, the results of genotyping / mutation and coronavirus variant
will be taken into account.
- Patients may be offered compensation (financial reward) for taking tests, participating
in a survey, and providing data and/or travel expenses for testing.
