Long-term Symptomatic Follow-up of Patients with Long COV... | NCT06879535

Studies
Long-term Symptomatic Follow-up of Patients with Long COVID Syndrome

NCT06879535

Sponsor

Hospital del Rio Hortega

Status

Active, not recruiting

Last Update Posted

Mar 17, 2025Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Long COVID

Interventions

Not provided

Countries

Spain

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2022Actual

Primary Completion Date

Mar 28, 2025Estimated

Completion Date

Mar 28, 2025Estimated

First Submitted Date

Mar 12, 2025

First Submission Date that Met QC Criteria

Mar 12, 2025

First Posted Date

Mar 17, 2025Actual

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

Mar 12, 2025

Last Update Posted Date

Mar 17, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrés Carrascosa Gil, Médico Licenciado Especialista en Anestesiología y Reanimación, Hospital del Rio HortegaPrincipal Investigator

Lead Sponsor

Hospital del Rio HortegaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about the long-term evolution of long COVID.

The main question it aims to answer is:

Does the main symptoms of the patients diagnosed with long COVID aproximate to those of patients who have had COVID acute infection without devoloping long COVID? Participants will answer mailed survey questions about their main symptons.

Detailed Description

Scales, indexes and questionnaires were mailed to 40 patients with long COVID to evaluate their main symptoms. Fatigue, emotional disorders, sleep disorders, cognitive impairments, dyspnea, physical activity, quality of life and pain were analyzed. The patients were reassessed after three years. The same scales, indexes and questionnaires were also sent to a control group of 40 volunteers of the same age and sex as the cases.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Patients diagnosed with long COVID
Controls		Patients who have had COVID acute infection without developing long COVID

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatigue	MFIS scale	From enrollment to three years later
Emotional disorders	HADS scale	From enrollment to three years later
Sleep disorders	PSQI	From enrollment to three years later
Cognitive impairments	MFE-30	From enrollment to three years later
Dyspnea	mMRC	From enrollment to three years later
Physical activity	GPAQ	From enrollment to three years later
Quality of life (healthcare)	SF-36	From enrollment to three years later
Pain (healthcare)	EGDC	From enrollment to three years later

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients older than 18 years old and younger than 75 years old
patients who accepted to participate in the study
patients who have had COVID acute infection
patients who have long COVID (cases)

Exclusion Criteria:

patients who refused to participate in the study at any time of the study
patients whose diagnosis of long COVID was revoked during the study (cases)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with long COVID who have been attended at the Internal Medicine Department at the Hospital Universitario Río Hortega from Valladolid

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Río Hortega		Valladolid	Valladolid	47012	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000094024	Post-Acute COVID-19 Syndrome

Ancestor Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

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Browse Branches

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