NCT05669235

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 29, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 29, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

December 29, 2022

Last Update Submit

October 12, 2023

Conditions

Keywords

COVID-19Long covidWomen

Outcome Measures

Primary Outcomes (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)

    Baseline

Secondary Outcomes (6)

  • Modified Medical Research Council Dyspnea Scale

    Baseline

  • Quality of life (EQ-5D)

    Baseline

  • Perceived Stress Scale (PSS)

    Baseline

  • Hospital Anxiety and Depression Scale (HADS)

    Baseline

  • Inventario de Depresión de Beck (BDI-2)

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

Long covid

Women who present symptoms after suffering from COVID-19, consistent with long covid.

Diagnostic Test: Questionnaires

Covid

Women who have passed COVID-19 without consequences.

Diagnostic Test: Questionnaires

Interventions

QuestionnairesDIAGNOSTIC_TEST

A series of questionnaires will be carried out that assess both respiratory problems, depression and strength.

CovidLong covid

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who have suffered from COVID-19 who have or have not had symptoms since then.

You may qualify if:

  • 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.

You may not qualify if:

  • They do not want to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

COVID-19Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 29, 2022

First Posted

December 30, 2022

Study Start

December 29, 2022

Primary Completion

February 28, 2023

Study Completion

October 1, 2023

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations