Covid19NCT05077982
The Long Term Effects of COVID on Pulmonary Function
An observational study of Covid19 and COVID-19 Pneumonia, run by Sciberras, Stephen M.D. at 2 sites in Malta.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Covid19, COVID-19 Pneumonia, Critical Illness
- What is being tested?
- Spirometry and 6-minute walk
- How many people
- 123 participants
- Where
- 2 sitesMalta
- Study dates
- 15 Oct 2021to 31 Jan 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients will be included
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Covid19, COVID-19 Pneumonia, Critical Illness, Quality of Life
- Being tested
- Spirometry, 6-minute walk
- Keywords
- Covid19, Critical Illness
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryDiagnostic test
Spirometry to assess lung function
6-minute walkDiagnostic test
Exercise tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start15 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciberras, Stephen M.D.
- Collaborators
- Mater Dei Hospital, Malta
- Responsible party
- Principal investigator, Stephen Sciberras, Sciberras, Stephen M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077982
- Sponsor's protocol ID
- LongTermCOVID
- Status last verified
- Apr 2023
- First submitted
- 26 Aug 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05077982
- Acronym / sponsor ID
- LongTermCOVID
- Conditions
- Covid19, COVID-19 Pneumonia, Critical Illness, Quality of Life
- Keywords
- Covid19, Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Sciberras, Stephen M.D.
- Collaborators
- Mater Dei Hospital, Malta
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 Oct 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be included
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria
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 |
|---|---|---|
| SpirometrySpirometry to assess lung function | Diagnostic test | – |
| 6-minute walkExercise tolerance | Diagnostic test | – |
Primary outcome
Long term general health effects of critical illness due to COVID-19 infection
Time frame: at 6 months
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
Long term general health effects of critical illness due to COVID-19 infection
Time frame: at 12 months
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
2 secondary outcomes
Correlation between severity of COVID19 illness and QOL
Time frame: at 6 months
Correlation between severity of COVID19 illness and QOL
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and COVID-19 Pneumonia, run by Sciberras, Stephen M.D. at 2 sites in Malta.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malta. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term general health effects of critical illness due to COVID-19 infection (time frame: at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.