B-DT-COV2: Biomarkers for Identification of COVID-19 Infection

• Sponsor: University of Catanzaro (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04322513
• Collaborator: Azienda Ospedaliera Pugliese Ciaccio (Other), Azienda Ospedaliera Universitaria Mater Domini, Catanzaro (Other)
• Enrollment: 110
• Location: 1
• Anticipated Duration (Months): 33.2
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus	Diagnostic Test: Biomarkers expression

Study Design

• Study Type: Observational
• Anticipated Enrollment: 110 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection
• Actual Study Start Date: Mar 24, 2020
• Actual Primary Completion Date: Jun 30, 2021
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Covid-19 positive patients all drugs used for standard treatment	Diagnostic Test: Biomarkers expression; Evaluation in biomarkers expression between 2 groups
Covid-19 negative patients	Diagnostic Test: Biomarkers expression; Evaluation in biomarkers expression between 2 groups

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Luca Gallelli	Catanzaro		Italy	88100

Sponsors and Collaborators

• University of Catanzaro
• Azienda Ospedaliera Pugliese Ciaccio
• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Luca Gallelli, Clinical Professor, University of Catanzaro
• ClinicalTrials.gov Identifier: NCT04322513
• Other Study ID Numbers: covid-19 biomarkers
• First Posted: Mar 26, 2020
• Last Update Posted: Oct 25, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Coronavirus Infections

Study Results

No Results Posted as of Oct 25, 2021