Respiratory Virus Metagenomics After COVID-19

Metagenomic Study on the Distributive Pattern of Respiratory Virus in the Community After the Emergence of COVID-19

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19 Respiratory Infection

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Shui Shan Lee, MD; Phone Number: 85222528812; Email: sslee@cuhk.edu.hk

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Shui Shan Lee, MD; Phone Number: 852 22528812; Email: sslee@cuhk.edu.hk
      • Contact: Ngai Sze Wong, PhD; Phone Number: 852 22528860; Email: candy_wong@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Subjects would be invited by post through randomly selected households throughout the territory of Hong Kong.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive identification of viruses	Proportion of specimens with identified respiratory virus taxa	4 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: metagenomic; respiratory virus infections; exposure risk
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Respiratory Tract Infections
• Other Study ID Numbers: Protocol HK COVID metagenomic

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No