COVID-19 Vaccination Status and The Clinical Outcomes of Long COVID-19 Patients (NCT05587868) | Clinical Trial Compass
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COVID-19 Vaccination Status and The Clinical Outcomes of Long COVID-19 Patients
Indonesia250 participantsStarted 2022-03-11
Plain-language summary
Long COVID is defined by the persistence or emergence of symptoms for more than 4 weeks beyond the acute phase of Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-CoV-2) infection. As the number of cases increases and various strains of SARS-CoV-2 emerge, so does the number of long COVID cases. Various multi-organ complications after COVID-19 infection include respiratory, cardiovascular, gastrointestinal, hepatobiliary, metabolic, and neuropsychiatric disorders. The symptoms and characteristics of Long COVID vary in each country.
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult patients aged ≥ 18 years
✓. 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
✓. Patients with/without comorbidities
✓. Willing to fill-out online Long COVID symptoms follow-up questionnaire
✓. Willing and able to comply with trial protocol (re-visits and physical testing)
Exclusion criteria
✕. Patients with no registered medical record number (MRN) at Dr. Cipto Mangunkusumo General Hospital
✕. Refusal to participate in the study or to sign the informed consent form
✕. Any contraindications for 6 Minute Walking Test according to the guidelines of the American Thoracic Society (ATS)
✕. Patients with no access to a smartphone or computer (desktop, laptop, or tablet) to fill out the online screening questionnaire
What they're measuring
1
Long COVID symptoms phenotype
Timeframe: Up to 6 months
2
Change in quality of life (QoL), self-assessed using the St George's Respiratory Questionnaire (SGRQ)
Timeframe: Baseline, 3 and 6 months
3
Change in quality of life (QoL), self-assessed using the Short Form (SF)-36 Health Survey questionnaire