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Clinical Trials/NCT04322513
NCT04322513
Unknown
Not Applicable

Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection

University of Catanzaro1 site in 1 country110 target enrollmentMarch 24, 2020
ConditionsCoronavirus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronavirus
Sponsor
University of Catanzaro
Enrollment
110
Locations
1
Primary Endpoint
Biomarkers expression
Last Updated
4 years ago

Overview

Brief Summary

Acute lung injury represents the most severe form of the viral infection sustained by coronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged in December 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-like syndrome with fever and cough; patients with clinical symptoms can perform a swab test, including molecular and/or antigen swab, for diagnosis of positivity to Covid-19. Even if diagnosis and treatment are well described, to date, this viral pandemic infection induces an increased mortality in the world. The aim of the present project is to evaluate specific biomarkers that could be used for patient stratification and for tailor therapy in COVID-19 infected patients.

Registry
clinicaltrials.gov
Start Date
March 24, 2020
End Date
December 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Catanzaro
Responsible Party
Principal Investigator
Principal Investigator

Luca Gallelli

Clinical Professor

University of Catanzaro

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 75 years, extremes included, male or female In conscious patients, ability to understand and the willingness to sign a written informed consent document; in unconscious patients informed consent will be signed from parents or legal tutors.

Exclusion Criteria

  • Patients that don't sign the informed consent

Outcomes

Primary Outcomes

Biomarkers expression

Time Frame: up to 30 days

Change in biomarkers (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) in covid-19 positive patients vs covid-negative patients

Liver Biomarkers expression

Time Frame: up to 30 days

Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy

Secondary Outcomes

  • biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment(60 days)

Study Sites (1)

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