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Analysis of factors associated with the presence of persistent symptoms in people with a diagnosis of COVID-19: a case-control study

Analysis of factors associated with the presence of persistent symptoms in people with a diagnosis of COVID-19: a case-control study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN27312680
Enrollment
400
Registered
2022-05-10
Start date
2022-03-28
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long COVID/post COVID-19 condition Infections and Infestations

Interventions

Current interventions as of 29/05/2024: The research assistant will call patients who have shown an interest in participating in the study and an appointment will be made at their health centre. At

Sponsors

Instituto de Investigación Sanitaria Aragón
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: Aged 16 to 75 years Case Group: Meet the diagnostic criteria of long COVID/post-COVID-19 condition (LC): complex multiorgan symptoms that affect patients who have suffered from COVID-19 (diagnosis confirmed with or without laboratory tests) and persist after the acute phase of the disease, after 4 or even 12 weeks Control Group (CG): Have been infected by COVID-19 as confirmed by RT-PCR, antigenic test or serology, from a duration no more than 4 weeks, without symptoms later

Exclusion criteria

Exclusion criteria: 1. Symptoms already existed before SARS-Cov-2 infection 2. Refusal to take part

Design outcomes

Primary

MeasureTime frame
1. COVID-19 persistent symptoms measured with a battery of questions at baseline that include: 1.1. Approximate date of the beginning of symptoms 1.2. Duration 1.3. Intensity of symptoms 1.4. Frequency of each symptom E.g. dysgeusia, dyspnea, neuromuscular conditions; measured at baseline, and revised with symptomatology 2. The severity of the first episode of COVID-19 measured with a battery of questions at baseline: 2.1. Approximate date of the beginning of symptoms 2.2. The first symptom and the most relevant symptom in their first contact with COVID-19 2.3. Hospitalization (Yes/No) or ICU (Yes/No) 2.4. Diagnosed confirmed with or without laboratory tests, and the date of the tests (CRP/antigenic test/serology) 2.5. Severity of the episode: mild/moderate/serious/critical (SEMI Classification)

Secondary

MeasureTime frame
1. Sociodemographic variables (sex, age, place of residence, occupation, habitability, ethnicity, origin) measured with a battery of questions at baseline. 2. Lifestyle variables: 2.1. Perceived quality of life measured using SF-12 scale at baseline 2.2. Consumption measured using a battery of questions at baseline 2.3. Diet measured using the PREDIMED scale at baseline 2.4. Sedentary lifestyle measured using the International Physical Activity Questionnaire (IPAQ) questionnaire at baseline 2.5. Sleeping habits measured using Pittsburg questionnaire at baseline 3. Comorbidity measured using ECH with medical records at baseline, including previous cardiovascular disease (chronic heart disease, heart failure, myocardial infarction, peripheral vascular disease, stroke), hypertension, dyslipidemia, respiratory diseases (COPD, asthma, chronic bronchitis), chronic renal disease, chronic liver disease, chronic neurological disorders, previous immunosuppression/transplant, chronic hematological diseases (leukemia, lymphoma, myeloma), cancer/neoplasm, HIV and others immunodeficiencies, obesity, malnutrition, diabetes, dermatological diseases, rheumatologic diseases, mental disorders and dementia, thyroid pathology, autoimmune pathology. 4. Clinics and treatment variables: 4.1. TA, Sat O2 %, body mass index (BMI) and temperature measured at baseline 4.2. Use of pharmacotherapy, nutritional supplements, and probiotics measured using a battery of questions (active ingredient, dose, medication schedule, approximate date from the beginning) at baseline 5. Emotional affective variable measured using the Patient Health Questionnaire-9 (PHQ-9) scale at baseline 6. Functional ability: 6.1 Functional status post-COVID 19 measured using Post-COVID-19 Functional Status (PCFS) at baseline 6.2 Functional physical skills measured using 1-min stand-sit test and 6-minute walk test at baseline 6.3 Respiratory function measured using spirometry at baseline 7. Cognitive ability: 7.1 Attention

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026