COVIDUNICODENCT04451577
Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection
An observational study of COVID, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts
Who may be able to join
- 1. Individuals aged ≥ 18 years;
Who cannot join
- 1. Lack of informed consent according to local procedure per critically ill patients.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Humanitas reseach hospital (ICH)
Rozzano, Milan, 20089
Maria Rescigno, PhD, +390282245431, maria.rescigno@hunimed.eu
About this study
Official title: Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection: a Retrospective-prospective Cohort Study
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.
Read the 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
- Conditions
- COVID
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, analysis of biological samples
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Immunological response to COVID-19
PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome (symptoms aggressiveness).
Measured: 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
Measured: 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04451577
- Sponsor's protocol ID
- UNICODE
- Acronym
- UNICODE
- Status last verified
- Jun 2020
- First submitted
- 25 Jun 2020
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic, Clinical, Molecular Characteristics of Hospital Employees With or Without Covid-19 Infection: a Retrospective-prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04451577
- Acronym / sponsor ID
- UNICODE / UNICODE
- Conditions
- COVID
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMPLOYEES WITHOUT COVID-19 INFECTION | – | Other: No interventionHumanitas 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 |
| EMPLOYEES WITH COVID-19 INFECTION | – | Other: No interventionHumanitas 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts
Key inclusion criteria (1 listed)
- 1. Individuals aged ≥ 18 years;
Key exclusion criteria (1 listed)
- 1. Lack of informed consent according to local procedure per critically ill patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention, analysis of biological samples | Other | EMPLOYEES WITH COVID-19 INFECTION, EMPLOYEES WITHOUT COVID-19 INFECTION |
Primary outcome
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.
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).
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Rescigno, PhD (00390282245431, maria.rescigno@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response to COVID-19 (time frame: 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.