NCT07321314

Brief Summary

RSV infection causes significant mortality and morbidity in susceptible adults. There are many publications on the global RSV disease burden in infants and young children but data on adults are lacking with lots of knowledge gaps. Currently there is no established effective antiviral therapy for RSV. RSV vaccines have recently become available commercially but the Center for Health Protection (Hong Kong) has yet to discuss procurement of RSV vaccines for the high risk groups. Thus a prospective study to assess the disease burden of RSV infection in adults would be of great interest.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Aug 2028

First Submitted

Initial submission to the registry

December 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

December 22, 2025

Last Update Submit

January 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of RSV infection

    The incidence of RSV infection based on the RSV detection rate in respiratory specimens collected from patients with respiratory tract infection symptoms

    1 month

Secondary Outcomes (1)

  • Incidence of severe RSV infection

    1 month

Study Arms (2)

RSV group

Patients with respiratory tract infection symptom and RSV confirmed in clinical specimens

Diagnostic Test: Serial specimen sampling

Control group

Patients with respiratory tract infection symptom but no RSV confirmed in clinical specimens

Interventions

Serial sampling of nasopharyngeal swab, saliva and sputum for RSV on day 3, 5, 7, 14, 28 (during hospitalization) for patients confirmed with RSV infection. Blood taking will be arranged on day 28 for serology purpose

RSV group

Eligibility Criteria

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

Patients hospitalized for community-acquired respiratory tract infection symptoms

You may qualify if:

  • Community-acquired respiratory tract infection symptoms
  • Age \>= 18

You may not qualify if:

  • Unable to provide a good quality of sputum and saliva

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal aspirate / swab, saliva, sputum, blood

Study Officials

  • David SC Hui, MD

    Chinese University of Hong Kong

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations