Respiratory Virus Metagenomics After COVID-19

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05126589
Collaborator
(none)
500
1
61.1
8.2

Study Details

Study Description

Brief Summary

The study aims to characterize the distributive pattern of viruses in upper airway and its relationship with influenza seasons, symptomatology and exposure setting. A total of 500 adults residing in Hong Kong would be recruited, who would complete a questionnaire and return self-collected nasal and throat swabs for metagenomic analyses.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. This is a serial cross-sectional study. Participants would be asked to complete a questionnaire and to self-collect nasal and throat swabs during a specified collection period with reference to an influenza season.

    2. Subjects would be invited by post through randomly selected households throughout the territory of Hong Kong. Eligible persons are adults normally resident in the address who could communicate in written Chinese or English. Persons incapable of giving informed consent would be excluded. Other exclusion criteria are: individuals with mental illnesses, prisoners. Approval is obtained from the clinical research ethics committee.

    3. A bilingual questionnaire would be administered, which consists of four parts, including: (a) Socio-demographics; (b) History of SARS-CoV-1 infection and vaccination; (c) Exposure settings preceding sample collection; (d) Presence and types (if any) of influenza-like illnesses (ILI) at the time of sample collection;

    4. With the provision of nasal and throat swab collection kits, participants shall collect the nasal/throat sample within a 3-month period from the start of an influenza season when one presents with influenza-like illnesses (ILI), or at the end of the season if no such illnesses occur. The self-collected swabs would need to be returned with the questionnaire within 48 hours after sampling. After returning the swabs, a HK$50 voucher would be given to compensate participants' time.

    5. RNA would be extracted from the collected samples, followed by by metagenomic analyses. The collected data would be tidied, checked and collated to form a research database. Descriptive statistics, including standard frequency tables and metrics, would be performed.

    6. The key outcomes in this study are the change of abundance of viruses in different influenza seasons, and the difference in distributions of viral taxa in samples from participants.

    7. On completion of the analyses, the transmission risk of respiratory infections could be assessed, and emerging viral infections could be identified. Certain exposure setting associated viruses could be identified to inform public health policies.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Metagenomic Study on the Distributive Pattern of Respiratory Virus in the Community After the Emergence of COVID-19
    Actual Study Start Date :
    Dec 28, 2021
    Anticipated Primary Completion Date :
    Jul 31, 2026
    Anticipated Study Completion Date :
    Jan 31, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Positive identification of viruses [4 years]

      Proportion of specimens with identified respiratory virus taxa

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • adults normally residing in Hong Kong

    • could communicate in English and/or Chinese

    • provision of consent

    Exclusion Criteria:
    • individuals with mental illness

    • prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Hong Kong Hong Kong China

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: Shui Shan Lee, Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shui-Shan Lee, MD, Research Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05126589
    Other Study ID Numbers:
    • Protocol HK COVID metagenomic
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shui-Shan Lee, MD, Research Professor, Chinese University of Hong Kong
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 9, 2022