Clinical trial NCT05077982: The Long Term Effects of COVID on Pulmonary Function
Official title: Long Term Outcomes of COVID-19 Critical Illness: Cohort Study of Adult Patients Admitted to the Intensive Care Unit at Mater Dei Hospital With COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
COVID-19 Pneumonia
Critical Illness
Quality of Life
Keywords: Covid19
Critical Illness
Lead sponsor: Sciberras, Stephen M.D.
Sponsor class: INDIV
Collaborators: name: Mater Dei Hospital, Malta
First posted: 2021-10-14
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients will be included

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the Intensive Care Unit with organ failure secondary to acute COVID-19 infection and successfully discharged from Mater Dei Hospital and surviving beyond 6 months after discharge, will be offered inclusion in the study.

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:

* There are no exclusion criteria

Primary outcomes:
measure: Long term general health effects of critical illness due to COVID-19 infection
timeFrame: at 6 months
measure: Long term general health effects of critical illness due to COVID-19 infection
timeFrame: at 12 months
Secondary outcomes:
measure: Correlation between severity of COVID19 illness and QOL
timeFrame: at 6 months
measure: Correlation between severity of COVID19 illness and QOL
timeFrame: at 12 months
Other outcomes:
Locations:
city: Imsida
country: Malta
facility: Mater Dei Hospital
city: Imsida
country: Malta
facility: Mater Dei Hospital
Study officials:
References: