NCT05835128

Brief Summary

The goal of this prospective multicentric study is to evaluate the presence of long-term pulmonary sequelae in patients who had required hospitalization for treating COVID-19 pneumonia, trough chest CT and pulmonary function tests (PFT). Secondly we would like to evaluate the possible correlation between the chest CT findings and pulmonary function tests pre-existing co-morbidities and type of therapy used during hospitalization.

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
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

March 1, 2020

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

4.8 years

First QC Date

April 25, 2023

Last Update Submit

September 28, 2023

Conditions

COVID-19 PneumoniaSequelae of; InfectionRespiratory Function ImpairedSARS CoV 2 InfectionSARS-CoV 2 Pneumonia

Keywords

COVID-19TomographyInfections, ViralRespiratory Tract InfectionsVirus DiseaseCoronavirus InfectionsInfectionsLung DiseasesRNA virus infectionsRespiratory tract diseasesChest CTReduced dose chest CTLung CTcoronaviridae infectionslung sequelapneumoniarespiratory function testsfollow-up studiesmulticentric studiesprospective studies

Outcome Measures

Primary Outcomes (3)

  • Prevalence of structural lung sequelae after COVID-19 pneumonia

    evaluate the presence of lung structural sequelae with chest CT

    12 -14 months

  • Prevalence of functional lung impairment after COVID-19 pneumonia

    evaluate the presence of impaired PFT after COVID-19 pneumonia

    12 -14 months

  • Association between chest CT findings and PFT impairment after COVID-19 pneumonia

    evaluate the possible correlation between the presence of pulmonary structural alterations on chest CT and the presence of impaired PFT

    12-14 months

Secondary Outcomes (7)

  • Prevalence of structural lung sequelae after COVID-19 pneumonia

    4-6 months

  • Prevalence of functional lung impairment after COVID-19 pneumonia

    4-6 months

  • Association between chest CT findings and PFT impairment after COVID-19 pneumonia

    4-6 months

  • Association between chest CT findings after COVID-19 pneumonia and therapy used during hospitalization

    4-6 months

  • Association between chest CT findings after COVID-19 pneumonia and therapy used during hospitalization

    12-14 months

  • +2 more secondary outcomes

Eligibility Criteria

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

The study will be conducted in two Portuguese hospitals from the same institution (university center). Patients will be recruited from the follow -up Post-COVID-19 medical consultations. All patients attending these follow- up consultations will be invited to participate and enrolled if they agree to sign the written informed consent (following the ethics committee protocol).

You may qualify if:

  • at least 18 years old of age;
  • positive SARS-CoV-2 reverse transcription-polymerase chain reaction on a nasopharyngeal and/or oropharyngeal swab or positive SARS-CoV-2 rapid antigen test
  • hospitalization in one of two hospitals of our institution (university center) in consequence of SARS-CoV-2 related disease between march of 2020 and march of 2022 and having :
  • respiratory insufficiency when admitted or developing after admission or image documented viral pneumonia ;
  • at least one thorax x-ray or lung CT acquired during the hospitalization period

You may not qualify if:

  • previous lung cancer
  • previous intersticial lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Faro (CHUA)

Faro, 8005, Portugal

Location

Hospital de Portimâo (CHUA)

Portimão, 8500-338, Portugal

Location

MeSH Terms

Conditions

InfectionsRespiratory InsufficiencyCOVID-19Virus DiseasesRespiratory Tract InfectionsCoronavirus InfectionsLung DiseasesRNA Virus InfectionsRespiratory Tract DiseasesCoronaviridae InfectionsPneumonia

Condition Hierarchy (Ancestors)

Respiration DisordersPneumonia, ViralNidovirales Infections

Study Officials

  • Mónica Diniz, MD

    unafilliated

    PRINCIPAL INVESTIGATOR

  • Castro Miguel, MD

    Centro Hospitalar Universitário do Algarve/Polo de Portimão

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2023

First Posted

April 28, 2023

Study Start

March 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

PT(2)