NCT05408286

Brief Summary

A multicenter longitudinal study with data collection at 4 and 8 months after hospital discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

March 4, 2022

Last Update Submit

June 6, 2022

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • COVID-19 qualità di vita

    polmonite COVID-19 qualità di vita

    8 mesi

Study Arms (1)

inclusion criteria

All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study.

Behavioral: administration of questionnaires

Interventions

administration of questionnairesBEHAVIORAL

administration of questionnaires

inclusion criteria

Eligibility Criteria

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

The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021

You may qualify if:

  • All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

Study Officials

  • Tatiana Bolgeo, PhD

    Azienda Ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, EU

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2022

First Posted

June 7, 2022

Study Start

November 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 7, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)