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Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection (UNICODE)

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ClinicalTrials.gov Identifier: NCT04451577
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief Summary:
The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts. Participants will be asked consent for the research use of blood, pharyngeal swab, and for those hospitalized for COVID-19, also for the bronchoalveolar lavage and fecal samples. Biological samples will be used to perform cellular, microbial and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease.

Condition or disease Intervention/treatment
COVID Other: No intervention

Detailed Description:

The analysis will include:

  • study the expression levels of molecules known to mediated viral infection, like the Angiotensin converting enzyme 2 (ACE2) and genetic variants in these genes, which could be related to susceptibility to the viral infection and/or to the severity of the clinical course of the disease
  • compare the frequency of genetic variants potentially related with COVID-19 susceptibility/severity in different subgroups of patients, ranging from individuals positive for the virus but asymptomatic to individuals affected by COVID-19 with ARDS requiring admission to ICU
  • germline DNA analysis to search for genetic factors predisposing or protecting against severe pulmonary affection in COVID-19 infected participants. To this aim DNA will be analyzed by a GWAS (Genome Wide Association Study) approach by using the GSA Illumina chip. The obtained data will also be used to try to develop a polygenic risk score to stratify individuals with a particularly high or low risk for severe disease course
  • explore the contribution of rare variants by studying the exome
  • sepsis and ARDS biomarkers developed at ICH (e.g. PTX3, sIL-1R2, MSF) analysis to address their prognostic potential in Covid-19 patients
  • PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome
  • microbiota analysis of residual BAL and pharyngeal swab to evaluate whether different microbial or metabolome profiles are associated to worsen disease or to protection
  • plasma and saliva/sputum test for anti-SARS-Cov-2 antibodies (IgM, IgG, IgE and IgA) and for microbiota analysis

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection: a Retrospective-prospective Cohort Study
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
EMPLOYEES WITHOUT COVID-19 INFECTION

Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts.

Negativity to COVOD-19 will be tested by peripheral blood samples every month for 6 months (or until seroconversion). If they are positive for anti- covid 19 antibodies, a test for positivity of the virus will be carried out. T

Other: No intervention
No intervention, analysis of biological samples

EMPLOYEES WITH COVID-19 INFECTION

Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts.

employees that are Sars-Cov-2 positive both symptomatic and asymptomatic, there will be at least 2 peripheral blood samples (5 and 3 ml) at every control visit until ascertained negativity. They will also undergo a pharyngeal swab for viral titers and microbiota analysis at enrollment and at negativity. In addition, a sample of saliva/sputum will be collected for most of the employees at positivity and at every control visit.

For employees hospitalized but not requiring intensive care the following samples will be collected:

  • an aliquot of samples from the respiratory tract (e.g., bronchial aspirate, bronchoalveolar lavage) residual from the normal clinical practice
  • saliva/sputum
  • pharyngeal swab not used for diagnosis both at admission and at the first check up
  • blood sample in EDTA for plasma and peripheral blood mononuclear cell (PBMC)
Other: No intervention
No intervention, analysis of biological samples




Primary Outcome Measures :
  1. Clinical response to COVID-19 [ Time Frame: 36 months ]
    COVID-19 infection will be assessed by serological analysis of the presence of IgG anti-Covid-19 antibodies, an a subsequent pharyngeal swab. Symphtoms and possible hospitalization will be considered in clinical response.

  2. Immunological response to COVID-19 [ Time Frame: 36 months ]
    PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome (symptoms aggressiveness).

  3. Genetic predisposition to COVID-19 [ Time Frame: 36 months ]
    Genetic variants analysis potentially related with COVID-19 susceptibility/severity in different subgroups of patients, ranging from individuals positive for the virus but asymptomatic to individuals affected by COVID-19 with ARDS requiring admission to ICU

  4. Microbiome-related response to COVID-19 [ Time Frame: 36 months ]
    Microbiota analysis (using 16S rDNA sequencing technology) of residual BAL, pharyngeal swab, plasma and saliva/sputum to evaluate whether different microbial or metabolome profiles are associated to worsen disease or to protection


Biospecimen Retention:   Samples With DNA
blood, pharyngeal swab, and for those hospitalized for COVID-19, also for the bronchoalveolar lavage and fecal samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts
Criteria

Inclusion Criteria:

  • 1. Individuals aged ≥ 18 years;

Exclusion Criteria:

  • 1. Lack of informed consent according to local procedure per critically ill patients.

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): NCT04451577


Contacts
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Contact: Maria Rescigno, PhD 00390282245431 maria.rescigno@hunimed.eu

Locations
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Italy
Humanitas reseach hospital (ICH) Recruiting
Rozzano, Milan, Italy, 20089
Contact: Maria Rescigno, PhD    +390282245431    maria.rescigno@hunimed.eu   
Sponsors and Collaborators
Istituto Clinico Humanitas
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT04451577    
Other Study ID Numbers: UNICODE
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
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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Infection