COVID-19 Vaccination Status and The Clinical Outcomes of Long COVID-19 Patients
NCT ID: NCT05587868
Last Updated: 2022-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2022-03-11
2023-05-31
Brief Summary
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Vaccination against SARS-CoV-2 has been documented to increase clinical resolution of Long COVID. In Indonesia, current full-dose vaccination coverage had merely reached 15.6% of the national vaccination target. This condition can be predictably associated with a longer duration and higher severity of symptoms in Long COVID patients.
The purpose of this study is to provide an overview of the symptoms and characteristics and determine whether vaccination against SARS-CoV-2 could improve clinical outcomes and quality of life of Long COVID patients at Dr. Cipto Mangunkusumo General Hospital.
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Detailed Description
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Baseline participant characteristics were collected before enrollment, including age, sex, body mass index, alcohol and smoking consumption, comorbidities, documented vaccination status, detailed history of laboratory-confirmed SARS-CoV-2 infection, Long COVID symptoms, severity, and duration. The Six-Minute Walking Test (6MWT) was performed according to the guidelines of the American Thoracic Society (ATS) to assess functional exercise capacity in each patient, followed by a quality of life assessment using the St George's Respiratory Questionnaire (SGRQ) and the Short Form (SF)-36 Health Survey questionnaire.
The primary outcomes of this study were long-COVID patients' characteristics, symptom phenotype, and changes in quality of life. The investigators anticipated a change in quality of life difference of 20%, with statistical power of 80% and a level of significance of 0.05. The total required sample size was 192 participants. In anticipation of participant drop-out, the investigators planned to recruit a total of 250 participants.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients who have not received vaccination for COVID-19
This group includes patients who refused or contraindicated to receive vaccination for COVID-19.
No interventions assigned to this group
Patients who had received first dose of vaccination for COVID-19
Regardless of the type of COVID-19 vaccine used (received before or after laboratory-confirmed SARS-CoV-2 infection).
COVID-19 Vaccine
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.
Patients who had received second dose vaccination for COVID-19
Regardless of the type of COVID-19 vaccine used, using same type of vaccine as the first dose (received before and/or after laboratory-confirmed SARS-CoV-2 infection).
COVID-19 Vaccine
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.
Patients who had received third dose/booster vaccination for COVID-19
Complete cycle of vaccination using same type of vaccine for the first and second dose and a same/different type for the third dose/booster (received before and/or after laboratory-confirmed SARS-CoV-2 infection).
COVID-19 Vaccine
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.
Interventions
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COVID-19 Vaccine
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.
Eligibility Criteria
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Inclusion Criteria
2. History of laboratory-confirmed SARS-CoV-2 infection via a positive molecular (RT-PCR) or antigen (lateral flow assay) test, receiving outpatient/inpatient care from Dr. Cipto Mangunkusumo General Hospital, anytime prior to enrollment in this study
3. Patients with/without comorbidities
4. Willing to fill-out online Long COVID symptoms follow-up questionnaire
5. Willing and able to comply with trial protocol (re-visits and physical testing)
Exclusion Criteria
2. Refusal to participate in the study or to sign the informed consent form
3. Any contraindications for 6 Minute Walking Test according to the guidelines of the American Thoracic Society (ATS)
4. Patients with no access to a smartphone or computer (desktop, laptop, or tablet) to fill out the online screening questionnaire
5. Patients who died during or before enrollment in the study
18 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Eric Daniel Tenda MD, DIC, PhD
Academic Staff in Respirology and Critical Illness Division, Department of Internal Medicine, Dr. Cipto Mangunkusumo General Hospital, Jakarta, Indonesia
Principal Investigators
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Eric D Tenda, MD, DIC, PhD
Role: PRINCIPAL_INVESTIGATOR
Fakultas Kedokteran Universitas Indonesia - Dr Cipto Mangunkusumo General Hospital
Locations
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Respirology and Critical Care Medicine Division, Departement of Internal Medicine, Dr Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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Central Contacts
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Ni N Indira
Role: CONTACT
References
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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WHO Coronavirus (COVID-19) - Dashboard
Long COVID: the NHS plan for 2021/22
Other Identifiers
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21-10-1101
Identifier Type: -
Identifier Source: org_study_id
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