A Randomized Study to Determine the Expression of the Furin Protein in Patients With SARS-CoV-2 and Vaccinated Against Coronavirus

NCT05104840 | Terminated

• 1 other identifier: 6564N20-20
• Study Type: observational
• Target: 2,432
• Locations: 3 countries
• Sites: 9

Brief 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)

Conditions

COVID-19; SARS-CoV-2; Furin; RGMc Processing; Paired Basic Amino Acid Cleaving Enzyme (PACE)

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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)

  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

  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)

  up to 12 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center Trials & Treatment: lead
• Oleg Martynenko: collaborator

Study Sites (9)

Mayo Clinic-Jacksonville

Jacksonville, Florida, 32034, United States

Location

StatMed Ocala

Ocala, Florida, 34471, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Seattle Intstitute of East Asian Medicine

Seattle, Washington, 98108, United States

Location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Humsafar Trust

Mumbai, 110065, India

Location

Max Super Speciality Hospital Saket

New Delhi, 110017, India

Location

Sher i Kashmir Institute of Medical Sciences

Srinagar, 190011, India

Location

State Institution Republican Clinical Hospital

Kyiv, 04053, Ukraine

Location

Related Links

• The role of furin cleavage site in SARS-CoV-2 spike protein-mediated membrane fusion in the presence or absence of trypsin
• The origin of SARS-CoV-2 furin cleavage site remains a mystery

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 3, 2021
• Study Start: August 10, 2022
• Primary Completion: March 27, 2023
• Study Completion: March 28, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: after the end of the research

Locations

UA (1); US (4); IN (4)