NCT07156890

Brief Summary

Outbreaks with viruses occur continuously, and novel viruses or new variants of existing viruses can surface after a zoonotic event or human-to-human transmission. This project proposal is designed to detect early circulation of (novel) respiratory viruses in both symptomatic and asymptomatic participants, either by direct detection of the virus or changes in local or systemic immunity. Additionally, SENTINEL will provide information on infectivity and (protective) immune responses in viral outbreaks or vaccination campaigns.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Aug 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Aug 2024Aug 2029

Study Start

First participant enrolled

August 19, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

August 27, 2025

Last Update Submit

September 4, 2025

Conditions

Keywords

healthcare workersrespiratory virusespandemic preparednessvirus-specific immunitysurveillancevaccines

Outcome Measures

Primary Outcomes (5)

  • Main study endpoint

    Identification of circulating respiratory viruses by targeted molecular testing in symptomatic participants

    60 months

  • Main study endpoint

    Identification of circulating respiratory viruses by metagenomic sequencing in symptomatic participants

    60 months

  • Main study endpoint

    Identification of circulating respiratory viruses by virus culture in symptomatic participants

    60 months

  • Main study endpoint

    Longitudinal monitoring of local immune responses, for example by, but not limited to, quantitative, qualitative and/or functional antibody assays (ELISA, VNT, PRNT) to detect changes as a proxy for asymptomatic exposure to respiratory viruses.

    60 months

  • Main study endpoint

    Longitudinal monitoring of systemic immune responses, for example by, but not limited to, quantitative, qualitative and/or functional antibody assays (ELISA, VNT, PRNT) to detect changes as a proxy for asymptomatic exposure to respiratory viruses.

    60 months

Secondary Outcomes (5)

  • Secondary study endpoint

    60 months

  • Secondary study endpoint

    60 months

  • Secondary study endpoint

    60 months

  • Secondary study endpoint

    60 months

  • Secondary study endpoint

    60 months

Study Arms (2)

Health care workers

Hospital staff with and without direct contact to patients (HCW)

Animal workers

Animal workers with direct contact to animals (AW)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals working at healthcare facilities or facilities with animals (e.g. farms, bird ringers, or slaughterhouses). We will include an average of 250 participants per year, over a maximum of 5 years. 1,000 participants will be recruited in total for the study.

You may qualify if:

  • years or older
  • Health care workers with or without direct patient contact
  • Animal workers with or without direct animal contact

You may not qualify if:

  • \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

50ml of whole blood per study visit, 1 throat swab per infection, 1 nasal fluid lining collector (nasosorption) per study visit, 1 nasal brush per study visit

Central Study Contacts

Corine H. Geurts van Kessel, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical microbiologist

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 5, 2025

Study Start

August 19, 2024

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

September 5, 2025

Record last verified: 2025-09

Locations