NCT05758649

Brief Summary

The study will assess cardiac and psychological profile at 2-3 months after recovery from COVID-19 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration 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

October 1, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

3.2 years

First QC Date

March 3, 2023

Last Update Submit

March 5, 2024

Conditions

Post-COVID Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of patients with cardiovascular or psychological sequelae

    3 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who will refer to the disease clinics 2-3 months after discharge from the COVID-19 areas of ICS Maugeri.

You may qualify if:

  • Recent discharge (≤ 3 months) from a COVID+ ward for SARS-CoV-2 disease

You may not qualify if:

  • Serious clinical conditions (severe chronic inflammatory diseases, neoplasms, neurological pathologies).
  • Non-Italian education, illiteracy, or return to illiteracy.
  • Severe visual-perceptual deficits.
  • Low motivation/interest or refusal to undergo the assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICS Maugeri

Pavia, 27100, Italy

Location

Related Publications (1)

  • Vigore M, Steccanella A, Maffoni M, Torlaschi V, Gorini A, La Rovere MT, Maestri R, Bussotti M, Masnaghetti S, Fanfulla F, Pierobon A. Patients' Clinical and Psychological Status in Different COVID-19 Waves in Italy: A Quanti-Qualitative Study. Healthcare (Basel). 2023 Sep 6;11(18):2477. doi: 10.3390/healthcare11182477.

    PMID: 37761674RESULT

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 7, 2023

Study Start

October 1, 2020

Primary Completion

December 31, 2023

Study Completion

February 29, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

IT(1)