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

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ClinicalTrials.gov Identifier: NCT03443102
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Zhancheng Gao, Peking University People's Hospital

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.

Condition or disease
SARS Virus Long-Term Survivors

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The 15-year Impact of Severe Acute Respiratory Syndrome on Organ Functions, Exercise Capacity, and Quality of Life in Survivors.
Actual Study Start Date : January 25, 2018
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. All-cause disability [ Time Frame: Evaluations would be finished within 90 days after enrollment. ]
    Disabilities arising from physical injuries and/or mental stresses


Secondary Outcome Measures :
  1. Cardiopulmonary function [ Time Frame: Evaluations would be finished within 90 days after enrollment. ]
    The interrelationship between the workings of the heart and lung organs would be assessed by assessed by 6MWT (6-min walk test)

  2. Life Life quaities mental distress [ Time Frame: Evaluations would be finished within 90 days after enrollment. ]
    Quality of life would be assessed by the Medical Outcomes Study 36-item short form version 2 (SF-36)


Biospecimen Retention:   Samples With DNA
Peripheral Blood Mononuclear Cells would be extracted from participators.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to continue the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443102


Contacts
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Contact: Yali Zheng, Dr +8615011451515 yali_zheng@126.com
Contact: Jia Li, Dr +8613661310120 lj10120@sina.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Yali Zheng, Dr    15011451515 ext 86    drylzheng@gmail.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Chair: Baoguo Jiang, Dr Peking University People's Hospital

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Responsible Party: Zhancheng Gao, Head of Respiartory and Critical Care Medicine, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03443102     History of Changes
Other Study ID Numbers: 2018PHB010-01
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases