NCT04416464

Brief Summary

Patients suffering from pneumonia due to SARS-CoV-2 infection, after admission to the Intensive Care Unit (ICU), are susceptible to development of various functional sequelae, increased risk of chronic diseases, increased mortality rates and existence of relevant impacts on their quality of life in the months and years that follow the ICU admission. The present study aims to assess the determinants of health-related quality of life and patient-centered long-term outcomes among patients recovered from SARS-COV-2 pneumonia, after discharge from the ICU, its determinants and predictors, in Portugal. It is a multicenter prospective cohort study of adult patients admitted at the ICU due to proven or suspected SARS-CoV-2 infection, included 90 days after discharge from the ICU. The primary outcome is one-year health-related quality of life assessed by the EQ-5D-3L. The secondary outcomes are all-cause mortality, rehospitalizations, return to work or study, the degree of dependence and functional capacity, symptoms of anxiety, depression and post-traumatic stress, level of physical activity and cognitive, renal and respiratory functions after ICU discharge. Investigators will collect data by means of structured telephone interviews, at a 12 months follow up period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

June 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 10, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

June 3, 2020

Last Update Submit

September 9, 2021

Conditions

Quality of LifeLong-term OutcomesCoronavirus InfectionMoralityRehospitalization

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life.

    The outcome will be assessed using the Portuguese version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).

    One-year (12 months) after ICU discharge.

Secondary Outcomes (13)

  • Length of stay at the ICU.

    The outcome will be assessed 3 months after ICU discharge (at the participant enrollment).

  • Incidence of all-cause mortality

    The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

  • Rehospitalization.

    The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

  • Percentage of long-term ventilatory support need.

    The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

  • Percentage of renal replacement therapy need.

    The outcome will be assessed at 3, 6, 9 and 12 months after ICU discharge.

  • +8 more secondary outcomes

Study Arms (1)

Pneumonia due to SARS-CoV-2 infection

Adult hospitalized patients with pneumonia due to proven or suspected SARS-Cov-2 infection.

Other: COVID-19 Pneumonia

Interventions

COVID-19 PneumoniaOTHER

Pneumonia due to proven or suspected SARS-Cov-2 infection

Pneumonia due to SARS-CoV-2 infection

Eligibility Criteria

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

Adult survivors of ICU admission and pneumonia due to proven or suspected SARS-CoV-2 infection.

You may qualify if:

  • Men and women aged 18 years and older
  • Admission to the intensive care unit (ICU)
  • Pneumonia due to proven or suspected SARS-CoV-2 infection

You may not qualify if:

  • Refusal to provide consent for the study by the patient or legal guardian
  • ICU length of stay less than 24 hours
  • Absence of telephone contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centro Hospitalar de Vila Nova de Gaia / Espinho - Unidade I

Vila Nova de Gaia, Porto District, 4434-502, Portugal

Location

Centro Hospitalar Universitário de São João

Porto, Portugal

Location

Centro Hospitalar Universitário do Porto - Hospital de Santo António

Porto, Portugal

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Luís Filipe Azevedo, Prof.

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 4, 2020

Study Start

June 15, 2020

Primary Completion

July 31, 2021

Study Completion

October 1, 2022

Last Updated

September 10, 2021

Record last verified: 2021-06

Locations

PT(3)