Clinical trial NCT04377464: COVID-19 - Quality of Life After Infection
Official title: COVID-19 - Quality of Life After Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Quality of Life
Keywords: COVID-19
Quality of Life
Follow-up
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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?

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Six-month SF-12v2(HK) Scores
timeFrame: July 1, 2020-January 31, 2021
Secondary outcomes:
measure: Six-month EQ-5D-5L Scores
timeFrame: July 1, 2020-January 31, 2021
measure: One-month SF-12v2(HK)
timeFrame: July 1, 2020-January 31, 2021
measure: One-month EQ-5D-5L Scores
timeFrame: July 1, 2020-January 31, 2021
measure: Three-month SF-12v2(HK) Scores
timeFrame: July 1, 2020-January 31, 2021
measure: Three-month EQ-5D-5L Scores
timeFrame: July 1, 2020-January 31, 2021
measure: One, Three and Six-month Return to Work Status
timeFrame: July 1, 2020-January 31, 2021
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Joseph Walline, MD
role: PRINCIPAL_INVESTIGATOR
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