The Long Term Effects of COVID on Pulmonary Function

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077982
• Other study ID #: LongTermCOVID
• Status: Completed
• Start date: October 15, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2023
• Source: Sciberras, Stephen M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Covid19
• Critical Illness
• Quality of Life

Intervention

Diagnostic Test:
• Spirometry
Spirometry to assess lung function
• 6-minute walk
Exercise tolerance

Locations

Country	Name	City	State
Malta	Mater Dei Hospital	Imsida
Malta	Mater Dei Hospital	Imsida

Sponsors (2)

Lead Sponsor	Collaborator
Sciberras, Stephen M.D.	Mater Dei Hospital, Malta

Country where clinical trial is conducted

Malta, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 6 months
Primary	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	at 12 months
Secondary	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.	at 6 months
Secondary	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.	at 12 months