The Long Term Effects of COVID on Pulmonary Function | NCT05077982

Studies
The Long Term Effects of COVID on Pulmonary Function

NCT05077982

Sponsor

Sciberras, Stephen M.D.

Status

Completed

Last Update Posted

Apr 12, 2023Actual

Enrollment

123Actual

Phase

Not provided

Conditions

Covid19
COVID-19 Pneumonia
Critical Illness
Quality of Life

Interventions

Spirometry
6-minute walk

Countries

Malta

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Jan 31, 2022Actual

First Submitted Date

Aug 26, 2021

First Submission Date that Met QC Criteria

Oct 12, 2021

First Posted Date

Oct 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2023

Last Update Posted Date

Apr 12, 2023Actual

Name	Class
Mater Dei Hospital, Malta	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spirometry	Diagnostic Test	Spirometry to assess lung function
6-minute walk	Diagnostic Test	Exercise tolerance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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 Outcomes

Measure	Description	Time Frame
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
Correlation between severity of COVID19 illness and QOL

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

All patients will be included

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mater Dei Hospital		Msida		MSD2090	Malta
Mater Dei Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 1, 2021	Aug 26, 2021	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D016638	Critical Illness

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013147	Spirometry
D016138	Walking

Ancestor Terms

ID	Term
D012129	Respiratory Function Tests
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided