COVID-19NCT05731817
Profile of COVID-19 Patients Related to Fatigue
An observational study of COVID-19, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Observational study
- How many people
- 398 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Background: More than half of recovered COVID-19 patients experience fatigue. Studies are needed to define the profile of these patients.
Objectives: Evaluate the profile of surviving patients of COVID-19 in relation to fatigue;
Methodology: Observational study. The profile of the survivors of COVID-19 will be described, dividing them into 2 groups based on the presence or absence of fatigue.
Patients will be recruited from the Virgen de las Nieves University Hospital in Granada.
The evaluation will be carried out through Google forms, telematic means or face-to-face depending on the variables.
A symptomatic evaluation of fatigue, aspects related to fatigue and physical performance will be carried out.
- Conditions
- COVID-19
- Being tested
- Observational study
- Keywords
- COVID-19, fatigue
- Medical subject headings
- COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
N/A - observational study.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients | COVID-19 patients Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Fatigue
To assess perceived fatigue using the borg modified scale. Scale ranges from 0 to 10, with higher punctuation indicating higher fatigue perception.
Measured: Through study completion, an average of 1 year
Multidimensional Fatigue
To assess multidimensional fatigue using the multidimensional fatigue inventory
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 1 year
Muscular Fatigue
To assess muscular fatigue using surface electromyography
Measured: Through study completion, an average of 1 year
Secondary outcomes (15)
COVID-19 information
To assess information about the date and symptoms when COVID-19 was diagnosed
Measured: Through study completion, an average of 1 year
Dyspnea
To assess Dyspnea perception using the borg modified scale
Measured: Through study completion, an average of 1 year
Cough
To assess cough using the leicester cough questionnaire
Measured: Through study completion, an average of 1 year
Pain intensity
To assess pain intensity using the visual analogue scale and brief pain inventory
Measured: Through study completion, an average of 1 year
Functional status
To assess functional status using the post-covid functional scale and functional independence measure
Measured: Through study completion, an average of 1 year
Frailty
To assess frailty using the clinical frailty scale
Measured: Through study completion, an average of 1 year
Health-related Quality of life
To assess health-related quality of life using the euroqol-5d
Measured: Through study completion, an average of 1 year
Psychological status
To assess Psychological status using the hospital anxiety and depression scale
Measured: Through study completion, an average of 1 year
Sleep quality
To assess sleep quality using the Pittsburgh Sleep Quality Index
Measured: Through study completion, an average of 1 year
Nutritional status
To assess nutritional status using the mini nutritional assessment
Measured: Through study completion, an average of 1 year
Physical activity
To assess physical activity using the international physical activity questionnaire. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in Metabolic Equivalent (MET)-min/week and time spent sitting.
Measured: Through study completion, an average of 1 year
Kinesiophobia
To assess kinesiophobia using the TAMPA scale
Measured: Through study completion, an average of 1 year
Exercise capacity
To assess exercise capacity using the Short Physical Performance Battery and the 6 minutes walk test
Measured: Through study completion, an average of 1 year
Strength
To assess strength using dynamometry
Measured: Through study completion, an average of 1 year
Heart rate variability
To assess heart rate variability using holter
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Feb 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Torres Sánchez, Universidad de Granada
- Investigators
- Irene Torres Sánchez, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731817
- Sponsor's protocol ID
- COVIDATE-01
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39942522
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile of COVID-19 Patients Related to Fatigue
- ClinicalTrials.gov ID
- NCT05731817
- Acronym / sponsor ID
- COVIDATE-01
- Conditions
- COVID-19
- Keywords
- COVID-19, fatigue
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: More than half of recovered COVID-19 patients experience fatigue. Studies are needed to define the profile of these patients.
Objectives: Evaluate the profile of surviving patients of COVID-19 in relation to fatigue;
Methodology: Observational study. The profile of the survivors of COVID-19 will be described, dividing them into 2 groups based on the presence or absence of fatigue.
Patients will be recruited from the Virgen de las Nieves University Hospital in Granada.
The evaluation will be carried out through Google forms, telematic means or face-to-face depending on the variables.
A symptomatic evaluation of fatigue, aspects related to fatigue and physical performance will be carried out.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients | – | Other: Observational studyCOVID-19 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyN/A - observational study. | Other | COVID-19 patients |
Primary outcome
Perceived Fatigue
Time frame: Through study completion, an average of 1 year
To assess perceived fatigue using the borg modified scale. Scale ranges from 0 to 10, with higher punctuation indicating higher fatigue perception.
Multidimensional Fatigue
Time frame: Through study completion, an average of 1 year
To assess multidimensional fatigue using the multidimensional fatigue inventory
Fatigue Severity
Time frame: Through study completion, an average of 1 year
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
Fatigue Impact
Time frame: Through study completion, an average of 1 year
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.
Muscular Fatigue
Time frame: Through study completion, an average of 1 year
To assess muscular fatigue using surface electromyography
15 secondary outcomes
COVID-19 information
Time frame: Through study completion, an average of 1 year
Dyspnea
Time frame: Through study completion, an average of 1 year
Cough
Time frame: Through study completion, an average of 1 year
Pain intensity
Time frame: Through study completion, an average of 1 year
Functional status
Time frame: Through study completion, an average of 1 year
Frailty
Time frame: Through study completion, an average of 1 year
Health-related Quality of life
Time frame: Through study completion, an average of 1 year
Psychological status
Time frame: Through study completion, an average of 1 year
Sleep quality
Time frame: Through study completion, an average of 1 year
Nutritional status
Time frame: Through study completion, an average of 1 year
Physical activity
Time frame: Through study completion, an average of 1 year
Kinesiophobia
Time frame: Through study completion, an average of 1 year
Exercise capacity
Time frame: Through study completion, an average of 1 year
Strength
Time frame: Through study completion, an average of 1 year
Heart rate variability
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 39942522Perez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Torres Sánchez, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Fatigue (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05731817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.