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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Spain1 site
  • University of Valencia

    Valencia, 46010

Other trials in Spain

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 groups in NCT05669235
Study groupRoleWhat they receive
Long covidWomen who present symptoms after suffering from COVID-19, consistent with long covid.
Receives: Diagnostic Test: Questionnaires
CovidWomen 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted30 Dec 2022
  2. Study start29 Dec 2022
  3. Primary completion28 Feb 2023
  4. Study completion1 Oct 2023

Resources

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)
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

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.

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