Long COVIDNCT05735782
Clinical and Biological Characterization of Post COVID-19 Syndrome
An observational study of Long COVID, run by Arturo Jauretche National University at 1 site in Argentina.
Trial summary
The goal of this observational study is to describe the symptoms that persist for more than 12 weeks after the acute episode in participants who had COVID-19, and compare the functional, socioeconomic and occupational effects with a post-COVID-19 control group without persistent symptoms after the COVID-19 acute… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long COVID
- What is being tested?
- Clinical, mental health and psychosocial profile of Post-COVID-19 syndrome and Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndrome
- How many people
- 75 participants
- Where
- 1 siteArgentina
- Study dates
- 16 Feb 2023to 30 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults living in Buenos Aires with history of COVID-19
Who may be able to join
- Age equal to or greater than 18 years;
- Documented SARS-CoV-2 infection by PCR or antigen test;
- Ability to understand the objectives of the study;
- Acceptance to participate in the study and willingness to sign the informed consent.
- Permanent residence in Buenos Aires Metropolitan Area.
Who cannot join
- Women who report being pregnant, who are in the puerperium or lactation period at the time of the evaluation.
- People with known chronic debilitating conditions, defined as:
- heart failure, ii. symptomatic Coronary Heart Disease, iii. Diagnosis of cancer in the last 5 years iv. symptomatic anemia, v. chronic obstructive pulmonary disease or greater than moderate asthma, vi. heart valve disease more than mild, vii. cognitive impairment prior to the diagnosis of COVID-19, viii. diagnosis of schizophrenia or depression, ix. any other condition that, at the discretion of the treating professional or the research team, may explain or justify the aforementioned symptoms.
- Participants who are undergoing an acute pathology or who have undergone it in the last 4 weeks. In this case, they may be contacted again, after the period of time considered acceptable by the treating professional or the research team to invite them to participate.
Trial locations and contacts
1 site in 1 country.
Javier Mariani, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital El Cruce
San Juan Bautista, Buenos Aires, 1888
Laura Y Antonietti, MD, MHA, 01158544004, laurayantonietti@gmail.com
Javier Mariani, MD
About this study
Official title: Association of Symptoms, Clinical and Biochemical Characteristics in Post COVID-19 Syndrome: a Case-control Study
The goal of this observational study is to describe the symptoms that persist for more than 12 weeks after the acute episode in participants who had COVID-19, and compare the functional, socioeconomic and occupational effects with a post-COVID-19 control group without persistent symptoms after the COVID-19 acute event.
The main questions it aims to answer are:
- What are the characteristics of symptoms that persist for more than 12 weeks in participants who have had COVID19 in the last year?
- What are the health-related quality of life and psychosocial effects in participants with persistent symptoms of COVID-19, compared to a post-COVID-19 control group without persistent symptoms after the acute episode of COVID-19?
Read the detailed description
Two groups of cases and one group of controls will be included. A group of cases with persistent respiratory and/or cardiovascular symptoms (cardiorespiratory cases), and another group with persistent non-cardiorespiratory symptoms.
Participants who report at least two symptoms of intensity greater than or equal to severe will be classified as non-cardiorespiratory cases.
Controls will be participants with a history of confirmed SARS-CoV-2 infection, but without current or past persistent symptoms (ie, who resolved their symptoms during the acute episode or whose symptoms did not persist more than 4 weeks after onset).
Controls will be matched to cases by sex, age (with a margin of up to ±5 years), and time since diagnosis of the COVID-19 episode considered as the origin of post-COVID-19 symptoms in the cases (with a margin of of ±30 days).
The visit will include the application of the questionnaires for the evaluation of symptoms and quality of life associated with health, the clinical evaluation and the extraction of a blood sample.
The extraction of a blood sample will allow biochemical determinations, the complete blood count and vitamin D level to be carried out. Subsequently, an aliquot will be reserved for mechanistic evaluation (inflammatory markers, immunological and microRNA studies).
- Conditions
- Long COVID
- Being tested
- Clinical, mental health and psychosocial profile of Post-COVID-19 syndrome, Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndrome
- Keywords
- Post-Acute COVID-19 Syndrome, Long COVID, Post-COVID Conditions, Post Acute COVID-19 Syndrome
- 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.
Clinical, mental health and psychosocial profile of Post-COVID-19 syndromeDiagnostic test
Evaluation of persistent symptoms of COVID-19 and its association with psychological, cognitive and social status in comparison to a healthy control group
Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndromeDiagnostic test
Determine the inflammatory, immune profile and ventricular function in post-COVID-19 participants compared to a control group
| Study group | Role | What they receive |
|---|---|---|
| Case-Control | Case group: Participants with persistent symptoms post-COVID-19 more than12 weeks after COVID-19 acute infection Control group: Participants without persistent symptoms after a COVID-19 acute infection. Receives: Diagnostic Test: Clinical, mental health and psychosocial profile of Post-COVID-19 syndrome; Diagnostic Test: Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial, Cognitive and Health-related Quality Of Life association with symptoms Post COVID-19 syndrome
Assessment of symptoms and health-related quality of life (ISARIC), fatigue (Chalder fatigue scale and SPHERE questionnaire) and psychosocial evaluation(PHQ-9 and GAD-7 questionnaires)
Measured: More than 12 weeks post- acute COVID-19 episode
Secondary outcomes (1)
IL-6, Anti-SARS-Cov-2 S-RBD IgG Antibodies and vitamin D levels
Evaluate inflammatory, immune and vitamin D profile in post-COVID-19
Measured: More than 12 weeks post- acute COVID-19 episode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start16 Feb 2023
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2023 (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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arturo Jauretche National University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital El Cruce, National University of Cuyo, Universidad Nacional de La Plata, University of Buenos Aires
- Responsible party
- Principal investigator, Laura Antonietti, Arturo Jauretche National University
- Investigators
- Laura Antonietti, MD, MHA, Principal investigator, Arturo Jauretche National UniversityJavier Mariani, MD, Study chair, Hospital El CruceWalter Manucha, PhD, Study chair, National University of CuyoMariela Paz, PhD, Study chair, University of Buenos AiresMartín Rumbo, PhD, Study chair, Universidad Nacional de La PlataLiliana Dain, PhD, Study chair, University of Buenos AiresCarlos Tajer, Study chair, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735782
- Sponsor's protocol ID
- PICTO-COVID-SECUELAS-00015
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Symptoms, Clinical and Biochemical Characteristics in Post COVID-19 Syndrome: a Case-control Study
- ClinicalTrials.gov ID
- NCT05735782
- Acronym / sponsor ID
- PICTO-COVID-SECUELAS-00015
- Conditions
- Long COVID
- Keywords
- Post-Acute COVID-19 Syndrome, Long COVID, Post-COVID Conditions, Post Acute COVID-19 Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Arturo Jauretche National UniversityUniversity, hospital or other
- Collaborators
- Hospital El Cruce, National University of Cuyo, Universidad Nacional de La Plata, University of Buenos Aires
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 21 Feb 2023 (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 describe the symptoms that persist for more than 12 weeks after the acute episode in participants who had COVID-19, and compare the functional, socioeconomic and occupational effects with a post-COVID-19 control group without persistent symptoms after the COVID-19 acute event.
The main questions it aims to answer are:
- What are the characteristics of symptoms that persist for more than 12 weeks in participants who have had COVID19 in the last year?
- What are the health-related quality of life and psychosocial effects in participants with persistent symptoms of COVID-19, compared to a post-COVID-19 control group without persistent symptoms after the acute episode of COVID-19?
Detailed description
Two groups of cases and one group of controls will be included. A group of cases with persistent respiratory and/or cardiovascular symptoms (cardiorespiratory cases), and another group with persistent non-cardiorespiratory symptoms.
Participants who report at least two symptoms of intensity greater than or equal to severe will be classified as non-cardiorespiratory cases.
Controls will be participants with a history of confirmed SARS-CoV-2 infection, but without current or past persistent symptoms (ie, who resolved their symptoms during the acute episode or whose symptoms did not persist more than 4 weeks after onset).
Controls will be matched to cases by sex, age (with a margin of up to ±5 years), and time since diagnosis of the COVID-19 episode considered as the origin of post-COVID-19 symptoms in the cases (with a margin of of ±30 days).
The visit will include the application of the questionnaires for the evaluation of symptoms and quality of life associated with health, the clinical evaluation and the extraction of a blood sample.
The extraction of a blood sample will allow biochemical determinations, the complete blood count and vitamin D level to be carried out. Subsequently, an aliquot will be reserved for mechanistic evaluation (inflammatory markers, immunological and microRNA studies).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case-Control | – | Diagnostic Test: Clinical, mental health and psychosocial profile of Post-COVID-19 syndrome, Diagnostic Test: Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndromeCase group: Participants with persistent symptoms post-COVID-19 more than12 weeks after COVID-19 acute infection Control group: Participants without persistent symptoms after a COVID-19 acute infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults living in Buenos Aires with history of COVID-19
Key inclusion criteria (5 listed)
- Age equal to or greater than 18 years;
- Documented SARS-CoV-2 infection by PCR or antigen test;
- Ability to understand the objectives of the study;
- Acceptance to participate in the study and willingness to sign the informed consent.
- Permanent residence in Buenos Aires Metropolitan Area.
Key exclusion criteria (4 listed)
- Women who report being pregnant, who are in the puerperium or lactation period at the time of the evaluation.
- People with known chronic debilitating conditions, defined as:
- Participants who are undergoing an acute pathology or who have undergone it in the last 4 weeks. In this case, they may be contacted again, after the period of time considered acceptable by the treating professional or the research team to invite them to participate.
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 |
|---|---|---|
| Clinical, mental health and psychosocial profile of Post-COVID-19 syndromeEvaluation of persistent symptoms of COVID-19 and its association with psychological, cognitive and social status in comparison to a healthy control group | Diagnostic test | Case-Control |
| Diagnostic performance of echocardiographic and biological markers in Post-COVID-19 syndromeDetermine the inflammatory, immune profile and ventricular function in post-COVID-19 participants compared to a control group | Diagnostic test | Case-Control |
Primary outcome
Psychosocial, Cognitive and Health-related Quality Of Life association with symptoms Post COVID-19 syndrome
Time frame: More than 12 weeks post- acute COVID-19 episode
Assessment of symptoms and health-related quality of life (ISARIC), fatigue (Chalder fatigue scale and SPHERE questionnaire) and psychosocial evaluation(PHQ-9 and GAD-7 questionnaires)
1 secondary outcome
IL-6, Anti-SARS-Cov-2 S-RBD IgG Antibodies and vitamin D levels
Time frame: More than 12 weeks post- acute COVID-19 episode
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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The Study of Brave-LC LDN Treatment Trial
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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.
Javier Mariani, MD contact
Laura Antonietti, MD, MHA principal investigator
Arturo Jauretche National University
Javier Mariani, MD study chair
Hospital El Cruce
Walter Manucha, PhD study chair
National University of Cuyo
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 Arturo Jauretche National University at 1 site in Argentina.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Feb 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 Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Antonietti, MD, MHA (+541158544004, laurayantonietti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial, Cognitive and Health-related Quality Of Life association with symptoms Post COVID-19 syndrome (time frame: More than 12 weeks post- acute COVID-19 episode). 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 21 Feb 2023.