Clinical Multimodal Surveillance of Respiratory Syndrome Pathogens

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.

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Key information

Conditions

Respiratory Tract Infections (RTI) Acute Respiratory Infections (ARIs) Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Respiratory Syndrome, Acute, Severe Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing You'an Hospital, Capital Medical University, Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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."

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.

Treatment and study plan

Tiered pathogen testing and multi-omics analysis

Diagnostic Test

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.

Primary outcomes

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

Time frame: 3 years
Immune response and antibody levels after respiratory syndrome-related infection or vaccination

Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jingwen Ai, M.D.

CONTACT

[email protected]

+86 17317958269

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jul 10, 2026
Registry last updated: Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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