An observational study in Respiratory Tract Infections (RTI), Respiratory Syndrome, Acute, Severe and Acute Respiratory Infections (ARIs), sponsored by Huashan Hospital. Recruiting at 31 sites in China. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Huashan Hospital · Observational
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.
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.
376 studies on the registry are indexed under Severe Acute Respiratory Syndrome; 15 are open to participants now.
This study's planned enrollment of 2,398 is above the median of 300 across 129 observational studies indexed under Severe Acute Respiratory Syndrome.
Browse Severe Acute Respiratory Syndrome studies →Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.
Compared within Severe Acute Respiratory Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Tract Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with respiratory syndrome treated in fever clinics, emergency departments, outpatient clinics, or inpatient wards of participating medical institutions across China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with respiratory syndrome: Eligible patients are identified using the following search criteria. Patients meeting any one of the following criteria should be included:
Medication: Receipt of any of the following antiviral agents:
Nirmatrelvir/Ritonavir Leritrelvir Xiannuotewei/Ritonavir Molnupiravir Azvudine Deuremidevir
Exclusion Criteria:
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Aug 2028, 35 months after the start.
Of 70 non-industry observational studies under Severe Acute Respiratory Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's planned 35 months is above that.
Counting every sponsor, half of 79 studies reached it within 12 months; a quarter within 4 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Severe Acute Respiratory Syndrome →