NCT05077982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

August 26, 2021

Last Update Submit

April 10, 2023

Conditions

Covid19COVID-19 PneumoniaCritical IllnessQuality of Life

Keywords

Covid19Critical Illness

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Correlation between severity of COVID19 illness and QOL

    at 6 months

  • Correlation between severity of COVID19 illness and QOL

    at 12 months

Interventions

SpirometryDIAGNOSTIC_TEST

Spirometry to assess lung function

6-minute walkDIAGNOSTIC_TEST

Exercise tolerance

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients will be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mater Dei Hospital

Msida, MSD2090, Malta

Location

Mater Dei Hospital

Msida, Malta

Location

MeSH Terms

Conditions

COVID-19Critical Illness

Interventions

SpirometryWalking

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor

Study Record Dates

First Submitted

August 26, 2021

First Posted

October 14, 2021

Study Start

October 15, 2021

Primary Completion

December 31, 2021

Study Completion

January 31, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

MA(2)