NCT05545332

Brief Summary

Longitudinal, prospective observational cohort study enrolling patients with persisting symptoms (\> 12 weeks) after COVID-19 in a multidisciplinary care model.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 3, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 19, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

August 19, 2022

Last Update Submit

September 16, 2022

Conditions

Keywords

post COVID-19 syndromlong COVIDlong term sequelae

Outcome Measures

Primary Outcomes (2)

  • Prevalence rates of post-COVID patients requiring multidisciplinary care.

    To quantify disease burden by prevalence rates of post-COVID patients requiring multidisciplinary care.

    2 years

  • Characterisation of symptom patterns associated with impaired functional status.

    Characterisation of symptom patterns associated with impaired post covid-19 functional status scale ≥ 2.

    up to 24 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible patients will be screened by primary physicians in Tyrol (Wester Austria) using the post-COVID-19 functional status (PCFS) scale to assess the functional status, and a symptom checklist for the presence and severity of the 10 most common symptoms.

You may qualify if:

  • Individuals with persistent post COVID symptoms ≥ 12 weeks
  • post COVID functional status scale (PCFS) ≥ 2

You may not qualify if:

  • observation time after infection \< 12 weeks
  • PCFS \< 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Innsbruck

Innsbruck, 6020, Austria

RECRUITING

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

Central Study Contacts

Judith M Löffler-Ragg

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 19, 2022

First Posted

September 19, 2022

Study Start

March 3, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

September 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

We provide all of the individual participant data collected during the trial after deidentification and to researchers who provide a methodologically sound proposal.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Beginning three months after publication and ending five years following article publication.
Access Criteria
Access to researchers who provide a methodologically sound proposal.

Locations