An observational study in Covid19, COVID-19 Pneumonia and Critical Illness, sponsored by Sciberras, Stephen M.D.. Completed at 2 sites in Malta. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Sciberras, Stephen M.D. · Observational
An observational cohort study of patients discharged from the ICU following admission with COVID19 infection, looking at their medical wellbeing 6 months after discharge from the ICU.
The COVID-19 epidemic has placed an unprecedented strain on medical services worldwide. Throughout 2020 and early 2021, hospitals and their critical care services have been inundated with patients suffering from critical illness due to COVID-19, some of whom developed multi-organ failure and required a prolonged ICU stay. While the medical literature is now replete with publications and research on the acute phase of illness due to COVID-19, including critical illness, there is a paucity of studies detailing the long-term outcomes following COVID-19 critical illness.
While the negative long-term physical health, mental health and quality-of-life related effects of ARDS have been well documented, there has been very little long-term COVID-19 ARDS specific outcome studies published.
This is an observational cohort study that aims to assess the long-term health outcomes of adult patients admitted to Mater Dei Hospital Intensive Care Unit with COVID-19 infection. Patients will initially be assessed at 6 months after discharge from ITU. They will be interviewed by trained researchers using validated questionnaires. These questionnaires will assess their physical health, mental health and functional status. Participants will be examined and asked to do a 6minute walk test also using validated non-invasive physical assessment tools. They will be offered pulmonary function tests to be carried out at the Pulmonary function laboratory.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 123 is below the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →Sciberras, Stephen M.D. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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All patients will be included
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A positive COVID PCR result before or during the patient's admission will be necessary for inclusion in the study. Participants will be over 18 years of age, with no restriction as regards race, ethnicity or gender.
Exclusion Criteria:
Spirometry to assess lung function
Exercise tolerance
Long term general health effects of critical illness due to COVID-19 infection
Observation of the effect critical illness due to COVID-19 has on a patients' health related quality of life at 6 and 12 months after discharge from the ICU
Time frame: at 6 months
Long term general health effects of critical illness due to COVID-19 infection
Observation of the effect critical illness due to COVID-19 has on a patients' health related quality of life at 6 and 12 months after discharge from the ICU
Time frame: at 12 months
Correlation between severity of COVID19 illness and QOL
Observation of how different severity of critical illness secondary to COVID-19 infection correlates with medium and long-term health related quality of life outcomes.
Time frame: at 6 months
Correlation between severity of COVID19 illness and QOL
Observation of how different severity of critical illness secondary to COVID-19 infection correlates with medium and long-term health related quality of life outcomes.
Time frame: at 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Oct 2021 to primary completion in Dec 2021, 2 months.
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Sciberras, Stephen M.D.