CClinicalTrials.gg
Status unknownNCT03443102Updated Feb 26, 2018

Long-term Assessment of Organ Functions Among Survivors of Severe Acute Respiratory Syndrome

An observational study in SARS Virus and Long-Term Survivors, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Sex
All
01

Study 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.

02

Conditions studied

  • SARS Virus
  • Long-Term Survivors
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Refusal to continue the study
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. All-cause disability

    Disabilities arising from physical injuries and/or mental stresses

    Time frame: Evaluations would be finished within 90 days after enrollment.

Secondary outcomes

  1. Cardiopulmonary function

    The interrelationship between the workings of the heart and lung organs would be assessed by assessed by 6MWT (6-min walk test)

    Time frame: Evaluations would be finished within 90 days after enrollment.

  2. Life Life quaities mental distress

    Quality of life would be assessed by the Medical Outcomes Study 36-item short form version 2 (SF-36)

    Time frame: Evaluations would be finished within 90 days after enrollment.

06

Study locations

1 of 1 sites recruiting
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 34819019 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT03443102
Lead sponsor
Peking University People's Hospital
Responsible party
Zhancheng Gao (Head of Respiartory and Critical Care Medicine, Peking University People's Hospital) — Principal investigator
First posted
Feb 22, 2018
Start date
Jan 25, 2018
Primary completion
Jul 1, 2018 (estimated)
Completion
Dec 1, 2018 (estimated)
Last update
Feb 26, 2018

Study contacts

Yali Zheng, Dr
Contact
yali_zheng@126.com
+8615011451515
Jia Li, Dr
Contact
lj10120@sina.com
+8613661310120
Baoguo Jiang, Dr
study chair · Peking University People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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