NCT05731817

Brief Summary

More than half of recovered COVID-19 patients experience fatigue. Studies are needed to define the profile of these patients. The objective of this study is to evaluate the profile of surviving patients of COVID-19 in relation to fatigue.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Feb 2023

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 Progress90%
Feb 2023Sep 2026

First Submitted

Initial submission to the registry

February 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

February 10, 2023

Last Update Submit

April 29, 2026

Conditions

COVID-19

Keywords

COVID-19fatigue

Outcome Measures

Primary Outcomes (5)

  • Perceived Fatigue

    To assess perceived fatigue using the borg modified scale. Scale ranges from 0 to 10, with higher punctuation indicating higher fatigue perception.

    Through study completion, an average of 1 year

  • Multidimensional Fatigue

    To assess multidimensional fatigue using the multidimensional fatigue inventory

    Through study completion, an average of 1 year

  • Fatigue Severity

    To assess fatigue severity using the fatigue severity scale. The total score ranges from 7 to 63 points, with higher punctuation indicating higher fatigue severity

    Through study completion, an average of 1 year

  • Fatigue Impact

    To assess fatigue impact using the modified fatigue impact scale. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities. This scale can range from 0 to 36.

    Through study completion, an average of 1 year

  • Muscular Fatigue

    To assess muscular fatigue using surface electromyography

    Through study completion, an average of 1 year

Secondary Outcomes (15)

  • COVID-19 information

    Through study completion, an average of 1 year

  • Dyspnea

    Through study completion, an average of 1 year

  • Cough

    Through study completion, an average of 1 year

  • Pain intensity

    Through study completion, an average of 1 year

  • Functional status

    Through study completion, an average of 1 year

  • +10 more secondary outcomes

Study Arms (1)

COVID-19 patients

COVID-19 patients

Other: Observational study

Interventions

Observational studyOTHER

N/A - observational study.

COVID-19 patients

Eligibility Criteria

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

COVID-19 patients

You may qualify if:

  • diagnosis of COVID-19
  • adults (\>18 years)
  • basic knowledge and access to the internet
  • wish to participate in the study and sign the informed consent

You may not qualify if:

  • patients with severe comorbidities that interfere with the ability to perform the study, and those with mental, physical or organic problems that under medical criteria may pose a risk to the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, Granada, Spain

Location

Related Publications (1)

  • Perez-Gisbert L, Morales-Garcia C, Sanchez-Martinez JA, Gonzalez-Gutierrez MV, Valenza MC, Torres-Sanchez I. Severity Matters: How COVID-19 Severity Impacts Long-Term Effects on Symptoms, Physical Activity and Functionality-An Observational Study. Healthcare (Basel). 2025 Feb 6;13(3):333. doi: 10.3390/healthcare13030333.

    PMID: 39942522DERIVED

MeSH Terms

Conditions

COVID-19Fatigue

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Irene Torres Sánchez, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD, Principal investigator

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 16, 2023

Study Start

February 15, 2023

Primary Completion

September 30, 2024

Study Completion (Estimated)

September 30, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

ES(1)