Long COVID is defined by the persistence or emergence of symptoms for more than 4 weeksbeyond 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, sodoes the number of long COVID cases. Various multi-organ complications after COVID-19infection include respiratory, cardiovascular, gastrointestinal, hepatobiliary,metabolic, and neuropsychiatric disorders. The symptoms and characteristics of Long COVIDvary in each country.Vaccination against SARS-CoV-2 has been documented to increase clinical resolution ofLong 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 alonger duration and higher severity of symptoms in Long COVID patients.The purpose of this study is to provide an overview of the symptoms and characteristicsand determine whether vaccination against SARS-CoV-2 could improve clinical outcomes andquality of life of Long COVID patients at Dr. Cipto Mangunkusumo General Hospital.
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.
Biological: COVID-19 Vaccine
Mandatory COVID-19 vaccination as part of the the Indonesian national government program.
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
Respirology and Critical Care Medicine Division, Departement of Internal Medicine, Dr Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Andry Setiadharma, MD
+6285714519367
andrysetiadharma@gmail.com
Ni N Indira
+6281390705913
Eric D Tenda, MD, DIC, PhD, Principal Investigator
Fakultas Kedokteran Universitas Indonesia - Dr Cipto Mangunkusumo General Hospital