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

March 12, 2025 updated by: Andrés Carrascosa Gil, Hospital del Rio Hortega

ESTUDIO DE APLICACIÓN DE ESCALAS PARA VALORACIÓN SINTOMÁTICA DEL SÍNDROME DE COVID PERSISTENTE

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47012
        • Hospital Universitario Rio Hortega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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

Description

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  • patients whose diagnosis of long COVID was revoked during the study (cases)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases
Patients diagnosed with long COVID
Controls
Patients who have had COVID acute infection without developing long COVID

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Rio Hortega

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Estimated)

March 28, 2025

Study Completion (Estimated)

March 28, 2025

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-PI197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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