COVID-19NCT05669235
Differences Between Women With COVID-19 and Long Covid
An observational study of COVID-19, run by University of Valencia at 1 site in Spain.
Trial summary
The coronavirus disease of 2019 (COVID-19) has infected more than 630 million people and resulted in more than 6.5 million deaths worldwide. Among the possible sequelae of the virus, a disorder called long COVID has shown to affect about 10% of those infected, mostly adult women, without comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- COVID-19
- What is being tested?
- Questionnaires
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 29 Dec 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- Women only
- Adult, Older adult
Study population: Women who have suffered from COVID-19 who have or have not had symptoms since then.
Who may be able to join
- Women between 18 and 65 years
- That they have passed COVID-19 at least once.
- Whether or not they have symptoms secondary to COVID-19.
Who cannot join
- They do not want to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences Between Women Who Have Suffered COVID-19 With Respect to Those Who Have Suffered Long Covid: Observational Study
The coronavirus disease of 2019 (COVID-19) has infected more than 630 million people and resulted in more than 6.5 million deaths worldwide. Among the possible sequelae of the virus, a disorder called long COVID has shown to affect about 10% of those infected, mostly adult women, without comorbidities.
Long COVID corresponds to a multisystemic syndrome following the acute period of the disease, in which the person maintains persistent symptoms such as fatigue, dyspnea, cough, memory loss, muscle and joint pain, among others.
Now that time has passed, it is necessary to verify why there are women who present symptoms of long covid and others do not.
- Conditions
- COVID-19
- Being tested
- Questionnaires
- Keywords
- COVID-19, Long covid, Women
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesDiagnostic test
A series of questionnaires will be carried out that assess both respiratory problems, depression and strength.
| Study group | Role | What they receive |
|---|---|---|
| Long covid | Women who present symptoms after suffering from COVID-19, consistent with long covid. Receives: Diagnostic Test: Questionnaires | |
| Covid | Women who have passed COVID-19 without consequences. Receives: Diagnostic Test: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessment Scale
Scale that measures fatigue, made up of 10 items rated from 1 to 5: 1. Never 2. Sometimes (think of a frequency of once a month or less, for example) 3. Regularly (for example, a couple of times a month) 4. often (think for example every week) 5. always (every day)
Measured: Baseline
Secondary outcomes (6)
Modified Medical Research Council Dyspnea Scale
The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases.
Describes baseline dyspnea, but does not accurately quantify response to treatment of chronic obstructive pulmonary disease (COPD).
Demonstrates at least moderate positive correlation with other dyspnea scores, including the baseline dyspnea index (BDI) and oxygen cost diagram (OCD). It measures the degree of dyspnea in 5 levels (from 0 to 4).
Measured: Baseline
Quality of life (EQ-5D)
The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L.
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome.
Measured: Baseline
Perceived Stress Scale (PSS)
A more precise measure of personal stress can be determined by using a variety of instruments that have been designed to help measure individual stress levels. The first of these is called the Perceived Stress Scale. The Perceived Stress Scale (PSS) is a classic stress assessment instrument. The tool, while originally developed in 1983, remains a popular choice for helping us understand how different situations affect our feelings and our perceived stress. The questions in this scale ask about your feelings and thoughts during the last month. In each case, you will be asked to indicate how often you felt or thought a certain way. Although some of the questions are similar, there are differences between them and you should treat each one as a separate question. The best approach is to answer fairly quickly. That is, don't try to count up the number of times you felt a particular way; rather indicate the alternative that seems like a reasonable estimate.
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS)
The Patient Health Questionnaire 9-item depression scale (PHQ-9) and 7-item Generalized Anxiety Disorder scale (GAD-7) are among the best validated and most commonly used depression and anxiety measures, respectively.20-25 They have been used in hundreds of research studies, incorporated into numerous clinical practice guidelines, and adopted by a variety of medical and mental health care practice settings. Importantly, the PHQ-9 and GAD-7 are public domain measures available in more than 80 translations, many of which can be freely downloaded at www.phqscreeners.com. This paper uses data from 3 clinical trials to examine the reliability and convergent, construct, and factor structure validity as well as sensitivity to change of the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) - a 16-item scale comprising the PHQ-9 and GAD-7 - as a composite measure of depression and anxiety.
Measured: Baseline
Inventario de Depresión de Beck (BDI-2)
This test consists of 21 multiple-choice questions, where the subject in question who takes the test must assess on a scale of 0 to 3 the degree to which he personally identifies with the answer he has answered in it (where 0 is that you do not identify at all, being able to conclude that you do not present the symptoms on which the question is concerned; and 3 is that there is an absolute identification, for which, the subject would suffer from the symptoms). It is a test that is easy to perform, in which the subject would not spend more than 10 or 15 minutes doing it.
Measured: Baseline
30 second sit-to-stand
Test that measures the number of times you can get up and sit down in a chair in 30 seconds.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start29 Dec 2022
- Primary completion28 Feb 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hernández-Guillén, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669235
- Sponsor's protocol ID
- OBS_LCOVID
- Status last verified
- Oct 2023
- First submitted
- 29 Dec 2022
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences Between Women Who Have Suffered COVID-19 With Respect to Those Who Have Suffered Long Covid: Observational Study
- ClinicalTrials.gov ID
- NCT05669235
- Acronym / sponsor ID
- OBS_LCOVID
- Conditions
- COVID-19
- Keywords
- COVID-19, Long covid, Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 30 Dec 2022 (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 coronavirus disease of 2019 (COVID-19) has infected more than 630 million people and resulted in more than 6.5 million deaths worldwide. Among the possible sequelae of the virus, a disorder called long COVID has shown to affect about 10% of those infected, mostly adult women, without comorbidities.
Long COVID corresponds to a multisystemic syndrome following the acute period of the disease, in which the person maintains persistent symptoms such as fatigue, dyspnea, cough, memory loss, muscle and joint pain, among others.
Now that time has passed, it is necessary to verify why there are women who present symptoms of long covid and others do not.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long covid | – | Diagnostic Test: QuestionnairesWomen who present symptoms after suffering from COVID-19, consistent with long covid. |
| Covid | – | Diagnostic Test: QuestionnairesWomen who have passed COVID-19 without consequences. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women who have suffered from COVID-19 who have or have not had symptoms since then.
Key inclusion criteria (3 listed)
- Women between 18 and 65 years
- That they have passed COVID-19 at least once.
- Whether or not they have symptoms secondary to COVID-19.
Key exclusion criteria (1 listed)
- They do not want to sign the informed consent.
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 |
|---|---|---|
| QuestionnairesA series of questionnaires will be carried out that assess both respiratory problems, depression and strength. | Diagnostic test | Covid, Long covid |
Primary outcome
Fatigue Assessment Scale
Time frame: Baseline
Scale that measures fatigue, made up of 10 items rated from 1 to 5: 1. Never 2. Sometimes (think of a frequency of once a month or less, for example) 3. Regularly (for example, a couple of times a month) 4. often (think for example every week) 5. always (every day)
6 secondary outcomes
Modified Medical Research Council Dyspnea Scale
Time frame: Baseline
Quality of life (EQ-5D)
Time frame: Baseline
Perceived Stress Scale (PSS)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Inventario de Depresión de Beck (BDI-2)
Time frame: Baseline
30 second sit-to-stand
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No
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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.
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 COVID-19, run by University of Valencia 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 3 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: finished, as of the sponsor's last update on 16 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Assessment Scale (time frame: Baseline). 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 16 Oct 2023.