Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens

July 3, 2026 updated by: Jingwen Ai, Huashan Hospital

Clinical Multimodal Early Warning Surveillance of Respiratory Syndrome Pathogens and Construction and Application of Prevention and Control Measures

This nationwide, multicenter observational study will establish and improve a hospital-based clinical surveillance and early warning system for respiratory syndrome pathogens. Clinical data and biospecimens generated during routine care will be collected from participating medical institutions every two weeks to monitor pathogen trends, support risk assessment, and provide evidence for prevention and control measures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will enroll eligible patients with respiratory syndrome from fever clinics, emergency departments, outpatient clinics, and inpatient wards in participating hospitals across seven administrative regions in China. Standardized clinical data, including demographic information, symptoms, diagnoses, laboratory tests, medication orders, oxygen therapy, hospitalization, ICU admission, and outcomes, will be reported through encrypted data channels every two weeks. For eligible participants meeting the tiered diagnostic criteria, respiratory samples and clinically remaining biospecimens will be tested using routine pathogen testing, multiplex PCR or targeted sequencing, metagenomic next-generation sequencing, antibody testing, cytokine testing, and exploratory multi-omics assays as clinically appropriate. The study aims to generate national and regional surveillance reports and support early warning, pathogen identification, and prevention and control strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100069
        • Recruiting
        • Beijing You'an Hospital, Capital Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510700
        • Recruiting
        • The Fifth Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050082
        • Recruiting
        • The 980th Hospital of the People's Liberation Army Joint Logistics Support Force
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150036
        • Recruiting
        • Heilongjiang Provincial Hospital
        • Contact:
      • Jiamusi, Heilongjiang, China, 154002
        • Recruiting
        • Jiamusi Central Hospital
        • Contact:
    • Henan
      • Shangqiu, Henan, China, 476000
        • Recruiting
        • Shangqiu Municipal Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Yichang, Hubei, China, 443003
        • Recruiting
        • Yichang Third People's Hospital
        • Contact:
          • Zhu Jin
          • Phone Number: 18654108@qq.co +86 13308608938
    • Hunan
      • Huaihua, Hunan, China, 418000
        • Recruiting
        • Hunan University of Medicine General Hospital
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014040
        • Recruiting
        • The Third Hospital of Baotou (Baotou City Hospital for Infectious Diseases)
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210022
        • Recruiting
        • Nanjing Hospital of Chinese Medicine
        • Contact:
      • Nantong, Jiangsu, China, 226006
        • Recruiting
        • The Third People's Hospital of Nantong (Nantong Hospital of Infectious Diseases)
        • Contact:
      • Wuxi, Jiangsu, China, 214005
        • Recruiting
        • Wuxi Fifth People's Hospital
        • Contact:
    • Jiangxi
      • Jiujiang, Jiangxi, China, 332000
        • Recruiting
        • Jiujiang No.1 People's Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110006
        • Recruiting
        • Shenyang Sixth People's Hospital
        • Contact:
    • Shaanxi
      • Yan’an, Shaanxi, China, 716000
        • Recruiting
        • Affiliated Hospital of Yan'an University
        • Contact:
    • Shandong
      • Zaozhuang, Shandong, China, 277100
        • Recruiting
        • Zaozhuang Municipal Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200233
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huashan Hospital Fudan University
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200136
        • Recruiting
        • Jinyang Community Health Service Center of Pudong New Area, Shanghai
        • Contact:
      • Shanghai, Shanghai Municipality, China, 201399
        • Recruiting
        • Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
      • Taiyuan, Shanxi, China, 030013
        • Recruiting
        • Children's Hospital of Shanxi Province
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300162
        • Recruiting
        • Characteristic Medical Center of Chinese People's Armed Police Force
        • Contact:
    • Xinjiang
      • Altay, Xinjiang, China, 836500
        • Recruiting
        • Altay Prefecture People's Hospital, Xinjiang
        • Contact:
      • Changji, Xinjiang, China, 831100
        • Recruiting
        • Changji Hui Autonomous Prefecture People's Hospital
        • Contact:
      • Ürümqi, Xinjiang, China, 830054
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
    • Yunnan
      • Hekou, Yunnan, China, 661399
        • Recruiting
        • Hekou Yao Autonomous County People's Hospital
        • Contact:
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • The First People's Hospital of Yunnan Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with respiratory syndrome treated in fever clinics, emergency departments, outpatient clinics, or inpatient wards of participating medical institutions across China.

Description

Inclusion Criteria:

  • Patients with respiratory syndrome: Eligible patients are those diagnosed with respiratory syndrome based on the predefined data dictionary and the following ICD-10 (International Statistical Classification of Diseases, 10th Revision) diagnosis codes: R05, R50, J00, J01, J02, J03, J04, J06, J07, J08, J09, J10, J11, J12, J13, J14, J15, J16, J17, J18, J20, J21, J98.414, and J98.802.

  • Patients with respiratory syndrome: Eligible patients are identified using the following search criteria. Patients meeting any one of the following criteria should be included:

    1. Medical history (History of Present Illness): Positive test result for a respiratory syndrome-related pathogen.
    2. Laboratory testing: Positive test result for a respiratory syndrome-related pathogen.

    3. Medication: Receipt of any of the following antiviral agents:

      Nirmatrelvir/Ritonavir Leritrelvir Xiannuotewei/Ritonavir Molnupiravir Azvudine Deuremidevir

    4. Diagnosis: Diagnosis containing the term "respiratory tract infection."

Exclusion Criteria:

  • Participants who may compromise the study results: Patients who are unable to provide a specimen or whose specimen volume is insufficient for laboratory testing.
  • Participants who are unable to comply with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Respiratory syndrome cohort
Patients entering fever clinics, emergency departments, outpatient clinics, or inpatient wards who meet the respiratory syndrome screening and diagnostic criteria.
Diagnostic test: Tiered pathogen testing and multi-omics analysis
Participants will undergo clinically indicated tiered testing, including SARS-CoV-2 nucleic acid testing, influenza A/B antigen or nucleic acid testing, routine blood testing, targeted sequencing or multiplex PCR, metagenomic next-generation sequencing, respiratory pathogen antibody testing, cytokine testing, and exploratory transcriptomics, metabolomics, proteomics, single-cell, microbiome, and related analyses using collected or clinically remaining samples.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants
Time Frame: 3 years
3 years
Immune response and antibody levels after respiratory syndrome-related infection or vaccination
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2025-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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