Biomarkers for Identification of COVID-19 Infection

Coronavirus Clinical Trial

— B-DT-COV2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322513
• Other study ID #: covid-19 biomarkers
• Status: Recruiting
• Start date: March 24, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: October 2021
• Source: University of Catanzaro
• Contact: LUCA GALLELLI
• Phone: 3339245656
• Email: gallelli[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Infections

Intervention

Diagnostic Test:
• Biomarkers expression
Evaluation in biomarkers expression between 2 groups

Locations

Country	Name	City	State
Italy	Luca Gallelli	Catanzaro

Sponsors (3)

Lead Sponsor	Collaborator
University of Catanzaro	Azienda Ospedaliera Pugliese Ciaccio, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers expression	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	up to 30 days
Primary	Liver Biomarkers expression	Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy	up to 30 days
Secondary	biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment	Changes in biomarkers in covid-19 patients before and after standard treatment	60 days