COVID-19NCT04377464
COVID-19 - Quality of Life After Infection
An observational study of COVID-19 and Quality of Life, run by Chinese University of Hong Kong.
Trial summary
This study aims to investigate the quality of life of COVID-19 patients after recovery and discharge from the hospital. Patients following-up at the PWH outpatient clinics will be enrolled for further evaluation via telephone follow-up at one, three, and six months after hospital discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Quality of Life
- What is being tested?
- SF12, EQ-5D-5L and work status standardized quantitative assessments
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2020to 30 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As of April 10, 2020, in the NTEC Hospital Authority cluster there have been 89 patients admitted to PWH (of which 17 patients have already been discharged) and 117 admitted to United Christian Hospital with 42 discharged so far.22 Both PWH and United Christian Hospital's COVID-19 patients will follow-up at the PWH infectious diseases specialist outpatient follow-up clinic. Based on prior studies at PWH with SARS patients, approximately 80% agreed to participate in follow-up studies, so we will likely enroll approximately 200 COVID-19 patients.
Who may be able to join
- All adult patients aged ≥18 years who present to the infectious disease follow-up clinic at PWH will be screened for inclusion in this study. The inclusion criteria are age ≥18 years, laboratory-confirmed COVID-19 infection with SARS-CoV-2, and patients who agree to follow-up for up to six months following their first interview.
Who cannot join
- Patients aged below 18 years will be excluded.
- Patients will be excluded if they meet ANY of the following criteria:
- Patients or their next of kin are unable to communicate in Chinese or English,
- Unwilling or unable to provide written informed consent,
- or Patients who will not be available for telephone follow-up at the scheduled times.
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to investigate the quality of life of COVID-19 patients after recovery and discharge from the hospital. Patients following-up at the PWH outpatient clinics will be enrolled for further evaluation via telephone follow-up at one, three, and six months after hospital discharge. SF12, EQ-5D-5L and work status standardized quantitative assessments of quality of life will be implemented via telephone follow-up at these time-points. Previous studies of patients infected with SARS-CoV-1 in 2003 at PWH showed that significant numbers of recovering patients had impaired long-term health status. It is important to see if these same problems also afflict patients infected with the SARS-CoV-2 virus (the novel coronavirus which causes COVID-19).
Read the detailed description
Nearly two million cases have been documented, and thousands have died of the 2019 coronavirus disease (COVID-19). Hong Kong has seen nearly 1,000 documented cases of COVID-19 as of April 11, 2020. Potentially many more cases have gone unreported. The virus that causes the COVID-19 disease, SARS-CoV2, is a coronavirus, from the same group of viruses as the SARS virus from 2003. Worldwide, COVID-19 has killed many more patients than SARS, yet the two viruses share a similar background.
As the peak of viral infections begins to recede, however, the main priority will shift to the process of recovery. Over the past 17 years, Professor David SC HUI has published multiple follow-up examinations of SARS patients conducted at the Prince of Wales Hospital (PWH) outpatient clinics. He found that SARS patients suffered serious long-term effects after ostensibly recovering from their illnesses. Moreover, healthcare workers, who were disproportionately affected by SARS infections in 2003 were also disproportionately affected by long-term disability. Like SARS, many COVID-19 patients require intensive care, intubation, and aggressive medical therapy. One of the treatments tried for SARS patients was high-dose corticosteroids, which has been associated with avascular necrosis of major joints and long term disability. As the COVID-19 pandemic only started a few months ago, it is still unknown if COVID-19 patients will suffer the same fate as SARS survivors.
Recent COVID-19 research has logically focused on the acute diagnosis and treatment of affected patients in order to avoid short -term morbidity and mortality. Past research looking at SARS outcomes showed that both the six month exercise capacity and health status of SARS survivors was lower than that of normal controls. Sepsis patients also experience serious disease caused by infection, and long-term reductions in quality of life have been described in survivors of sepsis. Patients who survive intensive care go on to show deficits in verbal learning and memory, resulting in limitations in returning to work or school. Many SARS survivors developed post-traumatic stress disorder and other debilitating psychological illnesses. Based on the Hong Kong experience with SARS, the investigators are concerned that COVID-19 survivors are at risk for similar challenges in quality of life after discharge from acute care.
The Accident and Emergency Medicine Academic Unit of the Chinese University of Hong Kong based at PWH has worked on multiple studies involving quality of life. In particular, the investigators have previously collaborated with Professor Hui and the CUHK Department of Medicine and Therapeutics (M\&T) on a quality of life follow-up study on SARS patients. As for studying health related quality of life, the investigators currently have an ongoing project examining the subject in trauma patients after discharge.
Several instruments have been widely used in quality of life research, including the 36-Item Short Form Health Survey (SF-36), the 12-Item Short Form Health Survey (SF-12), the World Health Organization Quality of Life Instruments (WHOQOL-BREF), EuroQoL-5D (EQ-5D-5L) and the Short-Form Six-Dimension (SF-6D). Our team has experience using the SF-36, SF-12v2(HK) and the EQ-5D-5L survey instruments for monitoring quality of life in research subjects in Hong Kong. For example, the investigators found that trauma patients in Hong Kong scored significantly worse on the SF-36 twelve months after injury. The investigators also found the most dramatic improvements happened in the first one to six months post-injury, and that 45% of subjects had achieved an excellent outcome by four years post-injury. The SF-12v2(HK) with four week recall is a modified version of the SF-36 to be shorter and quicker to use, while also already translated and validated in Hong Kong. The investigators aim to combine our experience with conducting quantitative quality of life studies with the CUHK Department of M\&T's expertise in coronavirus treatment and followup to explore the quality of life of COVID-19 patients in recovery.
The reported mortality rates for COVID-19 has so far been lower than SARS, although the higher absolute numbers of COVID-19 patients mean worldwide deaths are overall much higher. Trauma, sepsis and SARS survivors have all experienced significant long-term morbidity and decreased quality of life as a result of their injuries or infections. A previous study of patients infected with SARS-CoV-1 in 2003 at PWH showed that significant numbers of recovering patients had impaired long-term health status. The question this study hopes to answer is to what degree do COVID-19 patients suffer a similar fate? Has the knowledge gained from the SARS experience led to improved quality of life outcomes compared to SARS survivors? Or do the similarities between the viruses that cause SARS and COVID-19 extend to a reduced quality of life after recovery as well?
- Conditions
- COVID-19, Quality of Life
- Being tested
- SF12, EQ-5D-5L and work status standardized quantitative assessments
- Keywords
- COVID-19, Quality of Life, Follow-up
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF12, EQ-5D-5L and work status standardized quantitative assessmentsOther
Quality of life assessments
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Survivors | Patients following-up at the PWH outpatient clinics will be enrolled for further evaluation via telephone follow-up at one, three, and six months after hospital discharge. SF12, EQ-5D-5L and work status standardized quantitative assessments of quality of life will be implemented via telephone follow-up at these time-points. Receives: Other: SF12, EQ-5D-5L and work status standardized quantitative assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-month SF-12v2(HK) Scores
The primary outcome measure will be the health summary scores from Short Form Health Survey version 2 Hong Kong (SF-12v2(HK)) in COVID patients at six-months post-discharge from hospital.
Measured: July 1, 2020-January 31, 2021
Secondary outcomes (6)
Six-month EQ-5D-5L Scores
The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at six-months.
Measured: July 1, 2020-January 31, 2021
One-month SF-12v2(HK)
The secondary outcome measures will include the health status measures of the Short Form Health Survey version 2 Hong Kong (SF-12v2(HK)) at one-month.
Measured: July 1, 2020-January 31, 2021
One-month EQ-5D-5L Scores
The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at one-month.
Measured: July 1, 2020-January 31, 2021
Three-month SF-12v2(HK) Scores
The secondary outcome measures will include the health status measures of the Short Form Health Survey version 2 Hong Kong (SF-12v2(HK)) at three-months.
Measured: July 1, 2020-January 31, 2021
Three-month EQ-5D-5L Scores
The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at three-months.
Measured: July 1, 2020-January 31, 2021
One, Three and Six-month Return to Work Status
Return to work status in COVID patients at one, three and six-months post discharge from hospital.
Measured: July 1, 2020-January 31, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start5 May 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Walline, Chinese University of Hong Kong
- Investigators
- Joseph Walline, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377464
- Sponsor's protocol ID
- NTEC-2020-0227
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao S, Musa SS, Lin Q, Ran J, Yang G, Wang W, Lou Y, Yang L, Gao D, He D, Wang MH. Estimating the Unreported Number of Novel Coronavirus (2019-nCoV) Cases in China in the First Half of January 2020: A Data-Driven Modelling Analysis of the Early Outbreak. J Clin Med. 2020 Feb 1;9(2):388. doi: 10.3390/jcm9020388.
PubMed 32024089Li TS, Gomersall CD, Joynt GM, Chan DP, Leung P, Hui DS. Long-term outcome of acute respiratory distress syndrome caused by severe acute respiratory syndrome (SARS): an observational study. Crit Care Resusc. 2006 Dec;8(4):302-8.
PubMed 17227266Hui DS. Severe acute respiratory syndrome (SARS): lessons learnt in Hong Kong. J Thorac Dis. 2013 Aug;5 Suppl 2(Suppl 2):S122-6. doi: 10.3978/j.issn.2072-1439.2013.06.18.
PubMed 23977432Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
PubMed 32227758Griffith JF, Antonio GE, Kumta SM, Hui DS, Wong JK, Joynt GM, Wu AK, Cheung AY, Chiu KH, Chan KM, Leung PC, Ahuja AT. Osteonecrosis of hip and knee in patients with severe acute respiratory syndrome treated with steroids. Radiology. 2005 Apr;235(1):168-75. doi: 10.1148/radiol.2351040100. Epub 2005 Feb 9.
PubMed 15703312Li Y, Xia L. Coronavirus Disease 2019 (COVID-19): Role of Chest CT in Diagnosis and Management. AJR Am J Roentgenol. 2020 Jun;214(6):1280-1286. doi: 10.2214/AJR.20.22954. Epub 2020 Mar 4.
PubMed 32130038Shanmugaraj B, Siriwattananon K, Wangkanont K, Phoolcharoen W. Perspectives on monoclonal antibody therapy as potential therapeutic intervention for Coronavirus disease-19 (COVID-19). Asian Pac J Allergy Immunol. 2020 Mar;38(1):10-18. doi: 10.12932/AP-200220-0773.
PubMed 32134278Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
PubMed 32205204Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
PubMed 32187464Hui DS, Joynt GM, Wong KT, Gomersall CD, Li TS, Antonio G, Ko FW, Chan MC, Chan DP, Tong MW, Rainer TH, Ahuja AT, Cockram CS, Sung JJ. Impact of severe acute respiratory syndrome (SARS) on pulmonary function, functional capacity and quality of life in a cohort of survivors. Thorax. 2005 May;60(5):401-9. doi: 10.1136/thx.2004.030205.
PubMed 15860716Winters BD, Eberlein M, Leung J, Needham DM, Pronovost PJ, Sevransky JE. Long-term mortality and quality of life in sepsis: a systematic review. Crit Care Med. 2010 May;38(5):1276-83. doi: 10.1097/CCM.0b013e3181d8cc1d.
PubMed 20308885Rabiee A, Nikayin S, Hashem MD, Huang M, Dinglas VD, Bienvenu OJ, Turnbull AE, Needham DM. Depressive Symptoms After Critical Illness: A Systematic Review and Meta-Analysis. Crit Care Med. 2016 Sep;44(9):1744-53. doi: 10.1097/CCM.0000000000001811.
PubMed 27153046Semmler A, Widmann CN, Okulla T, Urbach H, Kaiser M, Widman G, Mormann F, Weide J, Fliessbach K, Hoeft A, Jessen F, Putensen C, Heneka MT. Persistent cognitive impairment, hippocampal atrophy and EEG changes in sepsis survivors. J Neurol Neurosurg Psychiatry. 2013 Jan;84(1):62-9. doi: 10.1136/jnnp-2012-302883. Epub 2012 Nov 7.
PubMed 23134661Mak IW, Chu CM, Pan PC, Yiu MG, Ho SC, Chan VL. Risk factors for chronic post-traumatic stress disorder (PTSD) in SARS survivors. Gen Hosp Psychiatry. 2010 Nov-Dec;32(6):590-8. doi: 10.1016/j.genhosppsych.2010.07.007. Epub 2010 Sep 15.
PubMed 21112450Rainer TH, Yeung JH, Cheung SK, Yuen YK, Poon WS, Ho HF, Kam CW, Cattermole GN, Chang A, So FL, Graham CA. Assessment of quality of life and functional outcome in patients sustaining moderate and major trauma: a multicentre, prospective cohort study. Injury. 2014 May;45(5):902-9. doi: 10.1016/j.injury.2013.11.006. Epub 2013 Nov 21.
PubMed 24314871
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 - Quality of Life After Infection
- ClinicalTrials.gov ID
- NCT04377464
- Acronym / sponsor ID
- NTEC-2020-0227
- Conditions
- COVID-19, Quality of Life
- Keywords
- COVID-19, Quality of Life, Follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 5 May 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 6 May 2020 (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.
This study aims to investigate the quality of life of COVID-19 patients after recovery and discharge from the hospital. Patients following-up at the PWH outpatient clinics will be enrolled for further evaluation via telephone follow-up at one, three, and six months after hospital discharge. SF12, EQ-5D-5L and work status standardized quantitative assessments of quality of life will be implemented via telephone follow-up at these time-points. Previous studies of patients infected with SARS-CoV-1 in 2003 at PWH showed that significant numbers of recovering patients had impaired long-term health status. It is important to see if these same problems also afflict patients infected with the SARS-CoV-2 virus (the novel coronavirus which causes COVID-19).
Detailed description
Nearly two million cases have been documented, and thousands have died of the 2019 coronavirus disease (COVID-19). Hong Kong has seen nearly 1,000 documented cases of COVID-19 as of April 11, 2020. Potentially many more cases have gone unreported. The virus that causes the COVID-19 disease, SARS-CoV2, is a coronavirus, from the same group of viruses as the SARS virus from 2003. Worldwide, COVID-19 has killed many more patients than SARS, yet the two viruses share a similar background.
As the peak of viral infections begins to recede, however, the main priority will shift to the process of recovery. Over the past 17 years, Professor David SC HUI has published multiple follow-up examinations of SARS patients conducted at the Prince of Wales Hospital (PWH) outpatient clinics. He found that SARS patients suffered serious long-term effects after ostensibly recovering from their illnesses. Moreover, healthcare workers, who were disproportionately affected by SARS infections in 2003 were also disproportionately affected by long-term disability. Like SARS, many COVID-19 patients require intensive care, intubation, and aggressive medical therapy. One of the treatments tried for SARS patients was high-dose corticosteroids, which has been associated with avascular necrosis of major joints and long term disability. As the COVID-19 pandemic only started a few months ago, it is still unknown if COVID-19 patients will suffer the same fate as SARS survivors.
Recent COVID-19 research has logically focused on the acute diagnosis and treatment of affected patients in order to avoid short -term morbidity and mortality. Past research looking at SARS outcomes showed that both the six month exercise capacity and health status of SARS survivors was lower than that of normal controls. Sepsis patients also experience serious disease caused by infection, and long-term reductions in quality of life have been described in survivors of sepsis. Patients who survive intensive care go on to show deficits in verbal learning and memory, resulting in limitations in returning to work or school. Many SARS survivors developed post-traumatic stress disorder and other debilitating psychological illnesses. Based on the Hong Kong experience with SARS, the investigators are concerned that COVID-19 survivors are at risk for similar challenges in quality of life after discharge from acute care.
The Accident and Emergency Medicine Academic Unit of the Chinese University of Hong Kong based at PWH has worked on multiple studies involving quality of life. In particular, the investigators have previously collaborated with Professor Hui and the CUHK Department of Medicine and Therapeutics (M\&T) on a quality of life follow-up study on SARS patients. As for studying health related quality of life, the investigators currently have an ongoing project examining the subject in trauma patients after discharge.
Several instruments have been widely used in quality of life research, including the 36-Item Short Form Health Survey (SF-36), the 12-Item Short Form Health Survey (SF-12), the World Health Organization Quality of Life Instruments (WHOQOL-BREF), EuroQoL-5D (EQ-5D-5L) and the Short-Form Six-Dimension (SF-6D). Our team has experience using the SF-36, SF-12v2(HK) and the EQ-5D-5L survey instruments for monitoring quality of life in research subjects in Hong Kong. For example, the investigators found that trauma patients in Hong Kong scored significantly worse on the SF-36 twelve months after injury. The investigators also found the most dramatic improvements happened in the first one to six months post-injury, and that 45% of subjects had achieved an excellent outcome by four years post-injury. The SF-12v2(HK) with four week recall is a modified version of the SF-36 to be shorter and quicker to use, while also already translated and validated in Hong Kong. The investigators aim to combine our experience with conducting quantitative quality of life studies with the CUHK Department of M\&T's expertise in coronavirus treatment and followup to explore the quality of life of COVID-19 patients in recovery.
The reported mortality rates for COVID-19 has so far been lower than SARS, although the higher absolute numbers of COVID-19 patients mean worldwide deaths are overall much higher. Trauma, sepsis and SARS survivors have all experienced significant long-term morbidity and decreased quality of life as a result of their injuries or infections. A previous study of patients infected with SARS-CoV-1 in 2003 at PWH showed that significant numbers of recovering patients had impaired long-term health status. The question this study hopes to answer is to what degree do COVID-19 patients suffer a similar fate? Has the knowledge gained from the SARS experience led to improved quality of life outcomes compared to SARS survivors? Or do the similarities between the viruses that cause SARS and COVID-19 extend to a reduced quality of life after recovery as well?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Survivors | – | Other: SF12, EQ-5D-5L and work status standardized quantitative assessmentsPatients following-up at the PWH outpatient clinics will be enrolled for further evaluation via telephone follow-up at one, three, and six months after hospital discharge. SF12, EQ-5D-5L and work status standardized quantitative assessments of quality of life will be implemented via telephone follow-up at these time-points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As of April 10, 2020, in the NTEC Hospital Authority cluster there have been 89 patients admitted to PWH (of which 17 patients have already been discharged) and 117 admitted to United Christian Hospital with 42 discharged so far.22 Both PWH and United Christian Hospital's COVID-19 patients will follow-up at the PWH infectious diseases specialist outpatient follow-up clinic. Based on prior studies at PWH with SARS patients, approximately 80% agreed to participate in follow-up studies, so we will likely enroll approximately 200 COVID-19 patients.
Key inclusion criteria (1 listed)
- All adult patients aged ≥18 years who present to the infectious disease follow-up clinic at PWH will be screened for inclusion in this study. The inclusion criteria are age ≥18 years, laboratory-confirmed COVID-19 infection with SARS-CoV-2, and patients who agree to follow-up for up to six months following their first interview.
Key exclusion criteria (5 listed)
- Patients aged below 18 years will be excluded.
- Patients will be excluded if they meet ANY of the following criteria:
- Patients or their next of kin are unable to communicate in Chinese or English,
- Unwilling or unable to provide written informed consent,
- or Patients who will not be available for telephone follow-up at the scheduled times.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SF12, EQ-5D-5L and work status standardized quantitative assessmentsQuality of life assessments | Other | COVID-19 Survivors |
Primary outcome
Six-month SF-12v2(HK) Scores
Time frame: July 1, 2020-January 31, 2021
The primary outcome measure will be the health summary scores from Short Form Health Survey version 2 Hong Kong (SF-12v2(HK)) in COVID patients at six-months post-discharge from hospital.
6 secondary outcomes
Six-month EQ-5D-5L Scores
Time frame: July 1, 2020-January 31, 2021
One-month SF-12v2(HK)
Time frame: July 1, 2020-January 31, 2021
One-month EQ-5D-5L Scores
Time frame: July 1, 2020-January 31, 2021
Three-month SF-12v2(HK) Scores
Time frame: July 1, 2020-January 31, 2021
Three-month EQ-5D-5L Scores
Time frame: July 1, 2020-January 31, 2021
One, Three and Six-month Return to Work Status
Time frame: July 1, 2020-January 31, 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Background: PubMed 32024089Zhao S, Musa SS, Lin Q, Ran J, Yang G, Wang W, Lou Y, Yang L, Gao D, He D, Wang MH. Estimating the Unreported Number of Novel Coronavirus (2019-nCoV) Cases in China in the First Half of January 2020: A Data-Driven Modelling Analysis of the Early Outbreak. J Clin Med. 2020 Feb 1;9(2):388. doi: 10.3390/jcm9020388.
- Background: PubMed 17227266Li TS, Gomersall CD, Joynt GM, Chan DP, Leung P, Hui DS. Long-term outcome of acute respiratory distress syndrome caused by severe acute respiratory syndrome (SARS): an observational study. Crit Care Resusc. 2006 Dec;8(4):302-8.
- Background: PubMed 23977432Hui DS. Severe acute respiratory syndrome (SARS): lessons learnt in Hong Kong. J Thorac Dis. 2013 Aug;5 Suppl 2(Suppl 2):S122-6. doi: 10.3978/j.issn.2072-1439.2013.06.18.
- Background: PubMed 32227758Bhatraju PK, Ghassemieh BJ, Nichols M, Kim R, Jerome KR, Nalla AK, Greninger AL, Pipavath S, Wurfel MM, Evans L, Kritek PA, West TE, Luks A, Gerbino A, Dale CR, Goldman JD, O'Mahony S, Mikacenic C. Covid-19 in Critically Ill Patients in the Seattle Region - Case Series. N Engl J Med. 2020 May 21;382(21):2012-2022. doi: 10.1056/NEJMoa2004500. Epub 2020 Mar 30.
- Background: PubMed 15703312Griffith JF, Antonio GE, Kumta SM, Hui DS, Wong JK, Joynt GM, Wu AK, Cheung AY, Chiu KH, Chan KM, Leung PC, Ahuja AT. Osteonecrosis of hip and knee in patients with severe acute respiratory syndrome treated with steroids. Radiology. 2005 Apr;235(1):168-75. doi: 10.1148/radiol.2351040100. Epub 2005 Feb 9.
- Background: PubMed 32130038Li Y, Xia L. Coronavirus Disease 2019 (COVID-19): Role of Chest CT in Diagnosis and Management. AJR Am J Roentgenol. 2020 Jun;214(6):1280-1286. doi: 10.2214/AJR.20.22954. Epub 2020 Mar 4.
- Background: PubMed 32134278Shanmugaraj B, Siriwattananon K, Wangkanont K, Phoolcharoen W. Perspectives on monoclonal antibody therapy as potential therapeutic intervention for Coronavirus disease-19 (COVID-19). Asian Pac J Allergy Immunol. 2020 Mar;38(1):10-18. doi: 10.12932/AP-200220-0773.
- Background: PubMed 32205204Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
- Background: PubMed 32187464Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
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- World Health Organization. Situation Report-78 HIGHLIGHTS.; 2020Link provided by the sponsor.
- Center for Health Protection G of the HKS. Centre for Health ProtectionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Joseph Walline, MD principal investigator
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Quality of Life, run by Chinese University of Hong Kong.
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 5 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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Joseph Walline, MD (+852 3505 1033, jwalline@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-month SF-12v2(HK) Scores (time frame: July 1, 2020-January 31, 2021). 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 NCT04377464, which also lists 20 linked publications.
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 6 May 2020.