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Biomarkers for Identification of COVID-19 Infection (B-DT-COV2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322513
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : October 25, 2021
Sponsor:
Collaborators:
Azienda Ospedaliera Pugliese Ciaccio
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Information provided by (Responsible Party):
Luca Gallelli, University of Catanzaro

Study Description
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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
Coronavirus Diagnostic Test: Biomarkers expression

Study Design
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Study Type : Observational
Estimated 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 : March 24, 2020
Actual Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment [ Time Frame: 60 days ]
    Changes in biomarkers in covid-19 patients before and after standard treatment


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of both sexes and > 18 years with and without covid-19 infection that came in hospital for flu-like syptoms: cough fever and dyspnea
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322513


Contacts
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Contact: LUCA GALLELLI 3339245656 ext 3339245656 gallelli@unicz.it

Locations
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Italy
Luca Gallelli Recruiting
Catanzaro, Italy, 88100
Contact: LUCA GALLELLI    3339245656 ext 3339245656    gallelli@unicz.it   
Sponsors and Collaborators
University of Catanzaro
Azienda Ospedaliera Pugliese Ciaccio
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
More Information
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Responsible Party: Luca Gallelli, Clinical Professor, University of Catanzaro
ClinicalTrials.gov Identifier: NCT04322513    
Other Study ID Numbers: covid-19 biomarkers
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases