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

SARS Virus Clinical Trial

Official title:

The 15-year Impact of Severe Acute Respiratory Syndrome on Organ Functions, Exercise Capacity, and Quality of Life in Survivors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03443102
• Other study ID #: 2018PHB010-01
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2018
• Last updated: February 22, 2018
• Start date: January 25, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: February 2018
• Source: Peking University People's Hospital
• Contact: Yali Zheng, Dr
• Phone: +8615011451515
• Email: yali_zheng[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Long-Term Survivors
• SARS Virus
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause disability	Disabilities arising from physical injuries and/or mental stresses	Evaluations would be finished within 90 days after enrollment.
Secondary	Cardiopulmonary function	The interrelationship between the workings of the heart and lung organs would be assessed by assessed by 6MWT (6-min walk test)	Evaluations would be finished within 90 days after enrollment.
Secondary	Life Life quaities mental distress	Quality of life would be assessed by the Medical Outcomes Study 36-item short form version 2 (SF-36)	Evaluations would be finished within 90 days after enrollment.