COVID-19NCT05104840
A Randomized Study to Determine the Expression of the Furin Protein in Patients With SARS-CoV-2 and Vaccinated Against Coronavirus
An observational study of COVID-19 and SARS-CoV-2, run by Center Trials & Treatment at 9 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2, Furin
- How many people
- 2,432 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 10 Aug 2022to 28 Mar 2023
- How long will I take part?
- 15 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients of coronavirus departments of hospitals and clinics of any specialization. * Hospital patients for COVID-19 treatment. * Patients with confirmed SARS-CoV-2 and on outpatient treatment. * Patients with confirmed SARS-CoV-2 and being treated at home under the remote supervision of a physician.
Who may be able to join
- Any gender
- Age > 18
- Hospitalized adult male and female patients with Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection
- Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection
- All Confirmed COVID-19 Patients by PCR or highly suspected patients admitted to the chest department's isolation unit during the duration of the study
- Able to understand and provide voluntary informed consent. Informed consent for participation in the study (consent can be oral if written consent cannot be expressed
- Vaccination with any type of SARS-CoV-2 vaccine
Who cannot join
- Other medical condition other than COVID-19 or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
- Suspected or known active systemic bacterial, viral (except SARS-CoV2 infection) or fungal infections
- Active herpes zoster infection
- Any physical examination findings and/or history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
- Participation in other clinical trials of investigational treatments for COVID-19.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Mayo Clinic-Jacksonville
Jacksonville, Florida, 32034
StatMed Ocala
Ocala, Florida, 34471
Seattle Intstitute of East Asian Medicine
Seattle, Washington, 98108
India4 sites
Humsafar Trust
Mumbai, 110065
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Max Super Speciality Hospital Saket
New Delhi, 110017
Sher i Kashmir Institute of Medical Sciences
Srinagar, 190011
About this study
Official title: Randomized Study on Determine the Expression of the Furin Protein in Patients With Confirmed COVID-19 Disease (in Various Phases of the Disease), Recovered From SARS-CoV-2 and Vaccinated Against Coronavirus (All Types of Vaccines)
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.
Read more
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)
Read the detailed 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.
- Conditions
- COVID-19, SARS-CoV-2, Furin, RGMc Processing, Paired Basic Amino Acid Cleaving Enzyme (PACE)
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: up to 12 month
Secondary outcomes (2)
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
Measured: 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)
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start10 Aug 2022
- Primary completion27 Mar 2023
- Study completion28 Mar 2023
Why it stopped: the company is liquidated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 2,432 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Center Trials & Treatment
- Sponsor type
- University, hospital or other
- Collaborators
- Oleg Martynenko
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104840
- Sponsor's protocol ID
- 6564N20-20
- Status last verified
- Mar 2023
- First submitted
- 28 Oct 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on Determine the Expression of the Furin Protein in Patients With Confirmed COVID-19 Disease (in Various Phases of the Disease), Recovered From SARS-CoV-2 and Vaccinated Against Coronavirus (All Types of Vaccines)
- ClinicalTrials.gov ID
- NCT05104840
- Acronym / sponsor ID
- 6564N20-20
- Conditions
- COVID-19, SARS-CoV-2, Furin, RGMc Processing, Paired Basic Amino Acid Cleaving Enzyme (PACE)
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the company is liquidated
- Enrolment
- 2,432 participants (actual)
- Lead sponsor
- Center Trials & TreatmentUniversity, hospital or other
- Collaborators
- Oleg Martynenko
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 3 Nov 2021 (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.
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)
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients of coronavirus departments of hospitals and clinics of any specialization. * Hospital patients for COVID-19 treatment. * Patients with confirmed SARS-CoV-2 and on outpatient treatment. * Patients with confirmed SARS-CoV-2 and being treated at home under the remote supervision of a physician.
Key inclusion criteria (7 listed)
- Any gender
- Age > 18
- Hospitalized adult male and female patients with Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection
- Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection
- All Confirmed COVID-19 Patients by PCR or highly suspected patients admitted to the chest department's isolation unit during the duration of the study
Key exclusion criteria (5 listed)
- Other medical condition other than COVID-19 or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
- Suspected or known active systemic bacterial, viral (except SARS-CoV2 infection) or fungal infections
- Active herpes zoster infection
- Any physical examination findings and/or history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
- Participation in other clinical trials of investigational treatments for COVID-19.
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 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 being treated in a hospital
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 patients with confirmed SARS-CoV2 and who are on outpatient treatment
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 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)
2 secondary outcomes
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
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)
Time frame: up to 12 month
Results and safety
The study was stopped early (reason given: the company is liquidated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- The role of furin cleavage site in SARS-CoV-2 spike protein-mediated membrane fusion in the presence or absence of trypsinLink provided by the sponsor.
- SARS-CoV-2 spike and its adaptable furin cleavage siteLink provided by the sponsor.
- The origin of SARS-CoV-2 furin cleavage site remains a mysteryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2, run by Center Trials & Treatment at 9 sites in 3 countries.
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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, India, Ukraine. 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?
The study was stopped early (reason given: the company is liquidated). 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 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). The study lists 3 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 29 Mar 2023.