SARS VirusNCT03443102
Long-term Assessment of Organ Functions Among Survivors of Severe Acute Respiratory Syndrome
An observational study of SARS Virus and Long-Term Survivors, run by Peking University People's Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS Virus, Long-Term Survivors
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2018to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003 will be enrolled.
Who may be able to join
- Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003
Who cannot join
- Refusal to continue the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yali Zheng, Dr, 15011451515 ext. 86, drylzheng@gmail.com
About this study
Official title: The 15-year Impact of Severe Acute Respiratory Syndrome on Organ Functions, Exercise Capacity, and Quality of Life in Survivors.
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.
- Conditions
- SARS Virus, Long-Term Survivors
- Medical subject headings
- Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause disability
Disabilities arising from physical injuries and/or mental stresses
Measured: Evaluations would be finished within 90 days after enrollment.
Secondary outcomes (2)
Cardiopulmonary function
The interrelationship between the workings of the heart and lung organs would be assessed by assessed by 6MWT (6-min walk test)
Measured: Evaluations would be finished within 90 days after enrollment.
Life Life quaities mental distress
Quality of life would be assessed by the Medical Outcomes Study 36-item short form version 2 (SF-36)
Measured: Evaluations would be finished within 90 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start25 Jan 2018
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS VirusStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhancheng Gao, Peking University People's Hospital
- Investigators
- Baoguo Jiang, Dr, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443102
- Sponsor's protocol ID
- 2018PHB010-01
- Status last verified
- Feb 2018
- First submitted
- 4 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 15-year Impact of Severe Acute Respiratory Syndrome on Organ Functions, Exercise Capacity, and Quality of Life in Survivors.
- ClinicalTrials.gov ID
- NCT03443102
- Acronym / sponsor ID
- 2018PHB010-01
- Conditions
- SARS Virus, Long-Term Survivors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003 will be enrolled.
Key inclusion criteria (1 listed)
- Health care workers who were working at Peking University People's Hospital during the SARS epidemic in 2002-2003
Key exclusion criteria (1 listed)
- Refusal to continue the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause disability
Time frame: Evaluations would be finished within 90 days after enrollment.
Disabilities arising from physical injuries and/or mental stresses
2 secondary outcomes
Cardiopulmonary function
Time frame: Evaluations would be finished within 90 days after enrollment.
Life Life quaities mental distress
Time frame: Evaluations would be finished within 90 days after enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Derived from this study: PubMed 34819019Li 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.
- Individual participant dataSharing planned: Undecided
Related trials for SARS Virus
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baoguo Jiang, Dr study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS Virus and Long-Term Survivors, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yali Zheng, Dr (+8615011451515, yali_zheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause disability (time frame: Evaluations would be finished within 90 days after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.