NCT03443102

Brief Summary

SARS-CoV has caused severe epidemic respiratory disease in human populations. By July 2003, a total of 8,096 probable cases of SARS had been reported including 774 deaths in 27 countries, around one-third of which were health care workers (HCWs). Previous studies have been reported about long-term impacts of SARS infection, including lung function deficiency, steroid-induced osteonecrosis, reduced exercise capacity, and impairment in health-related quality of life (HRQoL). HCWs, especially nurses, have been reported to experience greater psychological distress, particularly increased levels of posttraumatic stress symptomatology (PTSS). But the very complex impacts of this fatal infection on HCWs have not been fully elucidated. It is thus important to follow these occupational patients to detect and manage multi-organ sequelae and functional impairment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

February 4, 2018

Last Update Submit

February 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause disability

    Disabilities arising from physical injuries and/or mental stresses

    Evaluations would be finished within 90 days after enrollment.

Secondary Outcomes (2)

  • Cardiopulmonary function

    Evaluations would be finished within 90 days after enrollment.

  • Life Life quaities mental distress

    Evaluations would be finished within 90 days after enrollment.

Study Arms (2)

SARS survivors

First-line HCWs infected during the SRAS-CoV pandemic in Peking University People's Hospital, China. Diagnose was further confirmed by SARS-CoV seropositive results.

Controls

1. Coworkers of the infected HCWs, who also exposed to SARS patients or specimens. Infection was further excluded by SARS-CoV seronegative results. 2. Healthy controls matched for age, sex and disease condition, but without exposures to SARS virus.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003 will be enrolled.

You may qualify if:

  • Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003

You may not qualify if:

  • Refusal to continue the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

  • Li J, Zheng Y, Zhao L, Yue Z, Pan F, Chen Y, Yu B, Chen Y, Zhao G, Zhou Y, Gao Z. Investigation of the impact of SARS-CoV infection on the immunologic status and lung function after 15 years. BMC Infect Dis. 2021 Nov 24;21(1):1183. doi: 10.1186/s12879-021-06881-3.

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cells would be extracted from participators.

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Baoguo Jiang, Dr

    Peking University People's Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Respiartory and Critical Care Medicine

Study Record Dates

First Submitted

February 4, 2018

First Posted

February 22, 2018

Study Start

January 25, 2018

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations