Long COVIDNCT06879535
Long-term Symptomatic Follow-up of Patients with Long COVID Syndrome
An observational study of Long COVID, run by Hospital del Rio Hortega at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 28 Mar 2022to 28 Mar 2025
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with long COVID who have been attended at the Internal Medicine Department at the Hospital Universitario Río Hortega from Valladolid
Who may be able to join
- 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)
Who cannot join
- 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- patients whose diagnosis of long COVID was revoked during the study (cases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Long COVID
- Keywords
- Long COVID, Long-term follow-up, Symptoms, Scales
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients diagnosed with long COVID | |
| Controls | Patients who have had COVID acute infection without developing long COVID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
MFIS scale
Measured: From enrollment to three years later
Emotional disorders
HADS scale
Measured: From enrollment to three years later
Sleep disorders
PSQI
Measured: From enrollment to three years later
Cognitive impairments
MFE-30
Measured: From enrollment to three years later
Dyspnea
mMRC
Measured: From enrollment to three years later
Physical activity
GPAQ
Measured: From enrollment to three years later
Quality of life (healthcare)
SF-36
Measured: From enrollment to three years later
Pain (healthcare)
EGDC
Measured: From enrollment to three years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start28 Mar 2022
- Primary completion28 Mar 2025 (estimated)
- Study completion28 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés Carrascosa Gil, Hospital del Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879535
- Sponsor's protocol ID
- 21-PI197
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESTUDIO DE APLICACIÓN DE ESCALAS PARA VALORACIÓN SINTOMÁTICA DEL SÍNDROME DE COVID PERSISTENTE
- ClinicalTrials.gov ID
- NCT06879535
- Acronym / sponsor ID
- 21-PI197
- Conditions
- Long COVID
- Keywords
- Long COVID, Long-term follow-up, Symptoms, Scales
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 28 Mar 2025 (estimated)
- First posted
- 17 Mar 2025 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients diagnosed with long COVID |
| Controls | – | –Patients who have had COVID acute infection without developing long COVID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with long COVID who have been attended at the Internal Medicine Department at the Hospital Universitario Río Hortega from Valladolid
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue
Time frame: From enrollment to three years later
MFIS scale
Emotional disorders
Time frame: From enrollment to three years later
HADS scale
Sleep disorders
Time frame: From enrollment to three years later
PSQI
Cognitive impairments
Time frame: From enrollment to three years later
MFE-30
Dyspnea
Time frame: From enrollment to three years later
mMRC
Physical activity
Time frame: From enrollment to three years later
GPAQ
Quality of life (healthcare)
Time frame: From enrollment to three years later
SF-36
Pain (healthcare)
Time frame: From enrollment to three years later
EGDC
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 17 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Long COVID
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Long COVID, run by Hospital del Rio Hortega 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 2 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 17 Mar 2025. 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?
Fatigue (time frame: From enrollment to three years later). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2025.