NCT07694648

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,398

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

31 active sites

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 Progress30%
Sep 2025Sep 2028

Study Start

First participant enrolled

September 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 3, 2026

Last Update Submit

July 3, 2026

Conditions

Keywords

Respiratory syndromerespiratory pathogensclinical surveillanceearly warningmultiplex PCRmetagenomic next-generation sequencingmulti-omicsnationwide multicenter study

Outcome Measures

Primary Outcomes (2)

  • Detection rate and pathogen spectrum of respiratory syndrome pathogens among enrolled participants

    3 years

  • Immune response and antibody levels after respiratory syndrome-related infection or vaccination

    3 years

Study Arms (1)

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

Interventions

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.

Respiratory syndrome cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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:
  • Medical history (History of Present Illness): Positive test result for a respiratory syndrome-related pathogen.
  • Laboratory testing: Positive test result for a respiratory syndrome-related pathogen.
  • Medication: Receipt of any of the following antiviral agents:
  • Nirmatrelvir/Ritonavir Leritrelvir Xiannuotewei/Ritonavir Molnupiravir Azvudine Deuremidevir
  • Diagnosis: Diagnosis containing the term "respiratory tract infection."

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Beijing You'an Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510700, China

RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

The 980th Hospital of the People's Liberation Army Joint Logistics Support Force

Shijiazhuang, Hebei, 050082, China

RECRUITING

Heilongjiang Provincial Hospital

Harbin, Heilongjiang, 150036, China

RECRUITING

Jiamusi Central Hospital

Jiamusi, Heilongjiang, 154002, China

RECRUITING

Shangqiu Municipal Hospital

Shangqiu, Henan, 476000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Yichang Third People's Hospital

Yichang, Hubei, 443003, China

RECRUITING

Hunan University of Medicine General Hospital

Huaihua, Hunan, 418000, China

RECRUITING

The Third Hospital of Baotou (Baotou City Hospital for Infectious Diseases)

Baotou, Inner Mongolia, 014040, China

RECRUITING

Nanjing Hospital of Chinese Medicine

Nanjing, Jiangsu, 210022, China

RECRUITING

The Third People's Hospital of Nantong (Nantong Hospital of Infectious Diseases)

Nantong, Jiangsu, 226006, China

RECRUITING

Wuxi Fifth People's Hospital

Wuxi, Jiangsu, 214005, China

RECRUITING

Jiujiang No.1 People's Hospital

Jiujiang, Jiangxi, 332000, China

RECRUITING

Shenyang Sixth People's Hospital

Shenyang, Liaoning, 110006, China

RECRUITING

Affiliated Hospital of Yan'an University

Yan’an, Shaanxi, 716000, China

RECRUITING

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, 277100, China

RECRUITING

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Jinyang Community Health Service Center of Pudong New Area, Shanghai

Shanghai, Shanghai Municipality, 200136, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center

Shanghai, Shanghai Municipality, 201399, China

RECRUITING

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

Children's Hospital of Shanxi Province

Taiyuan, Shanxi, 030013, China

RECRUITING

Characteristic Medical Center of Chinese People's Armed Police Force

Tianjin, Tianjin Municipality, 300162, China

RECRUITING

Altay Prefecture People's Hospital, Xinjiang

Altay, Xinjiang, 836500, China

RECRUITING

Changji Hui Autonomous Prefecture People's Hospital

Changji, Xinjiang, 831100, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

RECRUITING

Hekou Yao Autonomous County People's Hospital

Hekou, Yunnan, 661399, China

RECRUITING

The First People's Hospital of Yunnan Province

Kunming, Yunnan, 650032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal and/or oropharyngeal swabs, sputum, clinically remaining bronchoalveolar lavage fluid, stool, urine, peripheral blood, and other clinically remaining samples when applicable will be used for pathogen detection, sequencing, antibody testing, cytokine testing, and exploratory multi-omics analyses.

MeSH Terms

Conditions

Respiratory Tract InfectionsSevere Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 10, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

July 10, 2026

Record last verified: 2026-07

Locations