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

NCT04451577 | Unknown

• 1 other identifier: UNICODE
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID

Outcome Measures

Primary Outcomes (4)

• Clinical response to COVID-19

  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.

  36 months

• Immunological response to COVID-19

  PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome (symptoms aggressiveness).

  36 months

• Genetic predisposition to COVID-19

  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

  36 months

• Microbiome-related response to COVID-19

  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

  36 months

Study Arms (2)

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

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

Interventions

No intervention OTHER

No intervention, analysis of biological samples

EMPLOYEES WITH COVID-19 INFECTION; EMPLOYEES WITHOUT COVID-19 INFECTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \. Individuals aged ≥ 18 years;

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas reseach hospital (ICH)

Rozzano, Milan, 20089, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, pharyngeal swab, and for those hospitalized for COVID-19, also for the bronchoalveolar lavage and fecal samples

Central Study Contacts

Maria Rescigno, PhD

CONTACT

00390282245431; maria.rescigno@hunimed.eu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2023
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)