Clinical trial NCT05587868: COVID-19 Vaccination Status and The Clinical Outcomes of Long COVID-19 Patients
Official title: Karakteristik Dan Pengaruh Vaksinasi COVID-19 Terhadap Klinis Dan Kualitas Hidup Pasien Long COVID di RSUPN Dr. Cipto Mangunkusumo
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
SARS CoV-2 Infection
Keywords: Long COVID
Post COVID-19 Syndrome
Post-Acute Sequelae of SARS-CoV2 Infection (PASC)
Chronic COVID-19
Post-Acute COVID-19
Long-haulers
COVID-19 Vaccine
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long COVID-19 patients received outpatient/inpatient care from Dr. Cipto Mangunkusumo General Hospital during the COVID-19 infection anytime before enrollment in this study.

Brief 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.

Detailed description: The study is a prospective cohort study designed to assess whether vaccination against SARS-CoV-2 could reduce the severity and duration of Long COVID, resulting in changes in quality of life in Long-COVID patients. This study was approved by the Institutional Review Board of Universitas Indonesia and informed consent was obtained before enrollment for patients eligible for this study. Allocation of participants to each group was done via vaccination status data collected before enrollment in this study.

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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients aged ≥ 18 years
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:

1. Patients with no registered medical record number (MRN) at Dr. Cipto Mangunkusumo General Hospital
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

Primary outcomes:
measure: Long COVID symptoms phenotype
timeFrame: Up to 6 months
measure: Change in quality of life (QoL), self-assessed using the St George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline, 3 and 6 months
measure: Change in quality of life (QoL), self-assessed using the Short Form (SF)-36 Health Survey questionnaire
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Change in functional exercise capacity, objectively measured using Six-Minute Walking Test (6MWT)
timeFrame: Baseline, 3 and 6 months
measure: Change in symptoms severity
timeFrame: Baseline, 3 and 6 months
measure: Change in symptoms frequency
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Respirology and Critical Care Medicine Division, Departement of Internal Medicine, Dr Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia - Dr Cipto Mangunkusumo General Hospital
name: Eric D Tenda, MD, DIC, PhD
role: PRINCIPAL_INVESTIGATOR
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