S Protein and COVID-19: a Monocentric Prospective Study
NCT ID: NCT05351385
Last Updated: 2024-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
70 participants
OBSERVATIONAL
2021-09-23
2024-12-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
COVID-19 Patients Characterization, Biobank, Treatment Response and Outcome Predictor
NCT04318366
Sensitivity Evaluation of Serological Tests for Covid-19
NCT04678024
Predictive Factors COVID-19 Patients
NCT04427345
COST (COvid STudio) ACTION: Study for the Evaluation of Specific Antibodies Anti Covid-19 Linked to Covid-19 Infection, Symptoms and Genetic Expression of ACE2 Polymorphisms in Patients (COST ACTION)
NCT04367402
Multiparametric Assessment of Peripheral Blood and Tissue Myeloid Cells. Phenotype for Precision Medicine in Patients With SARS-Cov-2 Infection
NCT05767853
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
There will be two cohorts:
* COVID + cohort: 50 patients with positive nasopharyngeal swab and / or BAL.
* Control Cohort: 20 patients with non-SARS-CoV-2 related pneumonia.
The study involves analyzing biological samples collected for normal clinical practice.
In particular:
* blood samples will be used for PROS and Sflt1 assay, haematological, biochemical and coagulation tests.
* Samples deriving from nasopharyngeal swab or from Broncho-Alveolar Lavage (BAL) liquid will be used for Real time PCR analysis to evaluate the viral load of SARS CoV-2.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Covid +
Patients SARS-CoV-2 positive.
Hematolgy and Chemistry analysis
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Real Time PCR
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
PROS assay COVID+
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Sflt1 assay COVID+
Samples will be collected at Day 0 and Day 10
Control
Patients with Pneumonia non-SARS-CoV-2 related
PROS assay CONTROL
Samples will be collected at Day 0 (+5)
Sflt1 assay CONTROL
Samples will be collected at Day 0 (+5)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hematolgy and Chemistry analysis
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Real Time PCR
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
PROS assay COVID+
Samples will be collected at Day 0, Day 5, Day 10 and Day 15
Sflt1 assay COVID+
Samples will be collected at Day 0 and Day 10
PROS assay CONTROL
Samples will be collected at Day 0 (+5)
Sflt1 assay CONTROL
Samples will be collected at Day 0 (+5)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects aged ≥ 18 years.
* Signing of the informed consent.
* Positivity for SARS-CoV-2 by RealTimePCR from nasopharyngeal swab or bronchial wash.
Cohort Control:
1. Subjects aged ≥ 18 years.
2. Signing of the informed consent.
3. Diagnosis of pneumonia not related to SARS-CoV-2, demonstrated by negative swab.
Exclusion Criteria
* Patients who are taking oral anticoagulant therapy (TAO) or new oral anticoagulants (NAO).
* Chronic liver failure (\> 5 points on the Child-Pugh score).
* Female subjects who are pregnant or on estrogen-progestogen replacement therapy.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
San Gerardo Hospital
OTHER
University of Milano Bicocca
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Luisa Verga, MD
Role: STUDY_DIRECTOR
San Gerardo Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
San Gerardo Hospital
Monza, Lombardy, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PROS-Covid
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.