Residual Symptoms After Coronavirus Disease (COVID-19) in... | NCT05000229

Studies
Residual Symptoms After Coronavirus Disease (COVID-19) in Lithuanian Population

NCT05000229

Sponsor

Lithuanian University of Health Sciences

Status

Unknown status

Last Update Posted

Aug 11, 2021Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Post-Covid Syndrome

Interventions

Not provided

Countries

Lithuania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2021Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Jul 16, 2021

First Submission Date that Met QC Criteria

Aug 10, 2021

First Posted Date

Aug 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2021

Last Update Posted Date

Aug 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dovilė Važgėlienė, MD, PhD-student, Lithuanian University of Health SciencesPrincipal Investigator

Lead Sponsor

Lithuanian University of Health SciencesOTHER

Collaborators

Name	Class
Karolinska Institutet	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to describe the post-covid-19 syndrome in Lithuanian population regarding the remaining symptoms and their impact on physical functioning, work ability and needs of rehabilitation.

Detailed Description

Participants with suspected and confirmed cases of COVID-19 infection will complete an anonymous online questionnaire for post-covid syndrome, i.e. symptoms lasting longer than 28 days after post-covid-19 syndrome. The online survey is developed to assess the health state before infection and residual symptoms lasting longer than acute COVID-19 infection, influencing the functional activity and work ability. The needs of rehabilitation will also be assessed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Description of post-covid-19 syndrome in Lithuanian population	Post-covid-19 syndrome in Lithuanian population: prevalence, symptomatology and needs of rehabilitation	2021.05.04 - 2022.12.31

Secondary Outcomes

Measure	Description	Time Frame
Assessment of medical premorbid status in post-covid-19 syndrome	The severity of comorbidities in terms of self-reported medical diagnoses and medication	2021.05.04 - 2022.12.31

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

older than 18 years age patients;
a history of COVID-19 infection that was and was not positive for SARS-CoV-2 diagnostic or antibody testing
the duration of remaining symptoms is longer than 28 days
ability to fulfil internet-based questionnaire

Exclusion Criteria:

ongoing covid-19 infection
other comorbidities requiring treatment or rehabilitation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The online study will be open to all volunteers over the age of 18 with COVID-19 infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dovilė Važgėlienė	Contact	+37064004420		do.bartkute@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lithuanian University of Health Sciences	Recruiting	Kaunas		44307	Lithuania