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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04643444
Other study ID # 2020-02650
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 9, 2021
Est. completion date June 2022

Study information

Verified date February 2021
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aim to determine the immune status of the employees of the cantonal police of Bern against SARS-CoV-2 over a period of 1 year, and to investigate the risk profile of the study participants and their risk of SARS-CoV-2 exposure in their working and private environments, as well as to evaluate the use of personal protective equipment at potential exposure instances.


Description:

i) To determine the extent of infection with seroprevalence data in the special population of police officers of the canton Bern. ii) To determine risk factors for infection by comparing the proportion of seropositivity (infected versus noninfected individuals). The investigators hypothesize that police officers with fieldwork activity will have a higher seroprevalence than will office and administration personnel. The investigators hypothesize that working in the city of Bern will be associated with a higher seroprevalence than will working in other geographic areas of the canton (i.e. rural area). iii) To monitor COVID-19 antibody titres and neutralizing capacity over time and to associate them with reinfection rates and infection-free intervals in police officers after accidental contact with a proven COVID-19 case. The investigators hypothesize that in seropositive individuals, there will be a decreasing dynamic of antibody titres over the one-year study period, and hence, a decrease of neutralizing capacity.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date June 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Police officers of the cantonal police of Bern volunteering to participate in the study. Exclusion Criteria: - Refusal or inability to give informed consent or contraindication to venepuncture.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Blood sampling
Testing for the presence of SARS-CoV-2 antibodies
Other:
Online Questionnaire
Questions on working place, risk profiles and PPE

Locations

Country Name City State
Switzerland University of Bern, Institute for Infectious Diseases Bern BE

Sponsors (2)

Lead Sponsor Collaborator
University of Bern Interregionale Blutspende SRK Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroprevalence The variable of primary interest is COVID-19 seropositivity. This variable is measured at five time points over the one-year study period. The following baseline factors may have an influence on the primary endpoint and will be obtained: (i) pre-existing comorbidities, (ii) rural versus city distribution of working place, and (iii) office work versus field work. One year
Secondary Risk profile assessment The investigators will assess the proportion of symptomatic and asymptomatic cases among seropositive participants. The investigators will calculate the attack rate in different subgroup. These include (i) study participants with health-related risk factors (age>50 and age>60 years, diabetes, arterial hypertension, cardiovascular disease, chronic pulmonary disease, immune-compromised status due to host diseases, medical treatment, cancer, obesity), (ii) activity-related subgroups (i.e. fieldwork vs office activity), (iii) geography-related subgroups (i.e. city vs rural areas). In follow-up visits, the antibody titers (i.e. dynamic) and the neutralization capacity will be assessed. Thereby, the investigators will determine the change in serum levels of SARS-CoV-2 antibodies over time in seropositive participants. One year
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