Biomarkers for Identification of COVID-19 Infection

• Conditions: Coronavirus
• Interventions: Diagnostic Test: Biomarkers expression

• Registration Number: NCT04322513
• Lead Sponsor: University of Catanzaro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study Start: 2020-03-24
• Study First Posted: 2020-03-26
• Primary Completion: 2021-06-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-25
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid-19 positive patients	Biomarkers expression	all drugs used for standard treatment
Covid-19 negative patients	Biomarkers expression	-

Primary Outcome Measures

Name	Time	Method
Biomarkers expression	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	up to 30 days	Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy

Secondary Outcome Measures

Name	Time	Method
biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment	60 days	Changes in biomarkers in covid-19 patients before and after standard treatment

Trial Locations

Locations (1)

Luca Gallelli; 🇮🇹 Catanzaro, Italy