NCT06879535

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 28, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 12, 2025

Last Update Submit

March 12, 2025

Conditions

Keywords

Long COVIDLong-term follow-upSymptomsScales

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

Cases

Patients diagnosed with long COVID

Controls

Patients who have had COVID acute infection without developing long COVID

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Río Hortega

Valladolid, Valladolid, 47012, Spain

Location

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
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Médico Licenciado Especialista en Anestesiología y Reanimación

Study Record Dates

First Submitted

March 12, 2025

First Posted

March 17, 2025

Study Start

March 28, 2022

Primary Completion

March 28, 2025

Study Completion

March 28, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations