Comparing S Protein levels and viral load in COVID-19 patients
S Protein and COVID-19: a Monocentric Prospective Study
This study is trying to see how S Protein levels in the blood relate to the amount of COVID-19 virus in patients, comparing those with COVID-19 to those with pneumonia from other causes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 1 site (Monza, Lombardia) |
| Trial ID | NCT05351385 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare plasma S Protein levels with SARS-CoV-2 viral load in patients diagnosed with COVID-19. It involves two cohorts: one with COVID-positive patients and another with patients suffering from pneumonia unrelated to SARS-CoV-2. Biological samples will be collected during routine clinical practice, including blood samples for various assays and nasopharyngeal swabs for PCR analysis. The study is designed to enhance understanding of the relationship between S Protein levels and viral load in COVID-19.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have tested positive for SARS-CoV-2 or have pneumonia not related to SARS-CoV-2.
Not a fit: Patients with congenital S Protein deficiency or those on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the role of S Protein in COVID-19, potentially leading to improved diagnostic and therapeutic strategies.
How similar studies have performed: While this approach is observational, similar studies have explored viral load and protein levels in COVID-19, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cohort COVID + : * 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 with a diagnosis of congenital S Protein deficiency. * 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.
Where this trial is running
Monza, Lombardia
- San Gerardo Hospital — Monza, Lombardia, Italy (Recruiting)
Study contacts
- Study coordinator: Daniela Ciulla, M.Sc
- Email: d.ciulla.hsg@gmail.com
- Phone: +392339883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.