Karakteristik Dan Pengaruh Vaksinasi COVID-19 Terhadap Klinis Dan Kualitas Hidup Pasien Long COVID di RSUPN Dr. Cipto Mangunkusumo
Conditions: COVID-19, SARS CoV-2 Infection
Sponsor: Indonesia University

 
 
 
COVID-19 Vaccination Status and The Characteristics and 
Clinical Outcomes of Long COVID-19 Patients in Dr. Cipto 
Mangunkusumo General Hospital 
 
 
 
 
Principal Investigator: 
Eric Daniel Tenda 
Dr. Cipto Mangunkusumo General Hospital 
Jakarta, Pangeran Diponegoro St No. 71, 10430 
Phone +62 813-8033-3818 
Email eric.tenda@ui.ac.id 
 
 

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STUDY PERSONNEL AND ROLES 
dr. Eric Daniel Tenda, DIC, Ph.D, SpPD 
Principal investigator 
dr. Mira Yulianti, SpPD-KP 
Co-Principal Investigator 
Dr. dr. Evy Yunihastuti, SpPD-KAI 
Chief Investigator 
Prasandhya Astagiri Yusuf, S.Si, M.T, Ph.D 
Co-Chief Investigator 
Dr. dr. Kuntjoro Harimurti, SpPD-KGer, M.Epid 
Medical Statisticians 
dr. Reyhan Eddy Yunus, Sp. Rad, M.Sc 
Data Protection Rep. 
dr. Ni Nyoman Indira, SpPD 
Study Coordinator 
Dr. dr. Cleopas Martin Rumende, SpPD-KP, FCCP 
Research Team 
Dr. dr. Lugiyanti Sukrisman, SpPD-KHOM 
Dr. dr. Sally Aman Nasution, SpPD-KKV 
dr. Ceva Wicaksono Pitoyo, SpPD-KP, KIC 
dr. Pringgodigdo, SpPD-KGH 
dr. Rudi Putranto, SpPD-KPsi 
dr. Findy Prasetyawati, SpPD-KHOM 
dr. Lusiani, SpPD-KKV 
dr. Wita Septiyanti, Sp.Rad 
dr. Moses Mazmur Asaf 
Department of Neurology 
Department of Psychiatry 
Department of Functional Improvement and Rehabilitation 
Department of Dermatovenereology 
 
 

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PROTOCOL SYNOPSIS 
Title 
COVID-19 Vaccination Status and The Characteristics and 
Clinical Outcomes of Long COVID-19 Patients in Dr. Cipto 
Mangunkusumo General Hospital 
Sponsor 
University of Indonesia 
Study Rationale 
Long COVID is the persistence or emergence of symptoms 
for more than four weeks beyond the acute phase of 
Severe Acute Respiratory Syndrome – Coronavirus-2 
(SARS-CoV-2) 
infection. 
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 the clinical resolution of Long COVID. 
However, in Indonesia, current full-dose vaccination 
coverage has 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. 
This study's point of view is to describe the incidence and 
the characteristic of long COVID in patients and the impact 
of COVID-19 vaccination on the clinical outcome of long 
COVID. In addition, this study is expected to reinforce the 
recommendation 
for 
the 
COVID-19 
vaccine 
implementation in Indonesia. The result of this study can 
be applied in clinical practice to ascertain the benefits of 
SARS-CoV-2 vaccination to improve clinical outcomes and 
quality of life; and reduce symptoms, duration, and 
frequency of long COVID. 
Study Objectives 
Primary  
• To provide an overview of the symptoms and 
characteristics of Long COVID patients at Dr. Cipto 
Mangunkusumo General Hospital. 
• To 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. 
Secondary  
• To determine whether vaccination against SARS-
CoV-2 could increase functional exercise capacity of 
Long COVID patients. 
• To determine whether vaccination against SARS-
CoV-2 could reduce symptoms, duration, and 
frequency of Long COVID. 
Study Design 
Prospective cohort study 

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Subject Population 
Key criteria for 
Inclusion and 
Exclusion: 
Inclusion Criteria 
1. Adult patients, aged ≥ 18 years old with a 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, any time 
prior to enrollment in this study. 
2. Patients with/without comorbidities. 
3. Willing to fill-out online Long COVID symptoms follow-
up questionnaire. 
4. Willing and able to comply with the trial protocol, 6 
Minutes Walking Test (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. Contraindicated to perform the 6 Minutes Walking 
Test.  
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. 
Number of Subjects 
A total of 250 subjects are divided into 4 groups according 
to SARS-CoV-2 vaccination status: 
• Never been vaccinated. 
• Received 1st dose of vaccination. 
• Received 2nd dose of vaccination. 
• Received 3rd dose of vaccination.  
Study Location 
Dr. Cipto Mangunkusumo General Hospital, Central 
Jakarta, Jakarta, Indonesia 
Study Duration 
Each subject’s participation will last for 6 months. The 
estimated duration for the main protocol is approximately 1 
year.  
Study Phases 
Screening 
Study Examination 
Follow-up 
 
Screening for eligibility and obtaining consent. 
Online questionnaire filling, 6-Minute Walking Test (6MWT) 
Follow-up examination 3 and 6 months after baseline. 
Safety Evaluations 
Adverse events will be monitored and collected by the 
study team from the point of signed consent until the 
adverse event(s) are resolved and subjects are stabilized. 
Adverse events will be managed according to the 6MWT 
guidelines of the American Thoracic Society (ATS). 
 
 

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Statistical and 
Analytic Plan 
Statistical analyses will be performed using SPSS version 
20. Descriptive statistics will describe the incidence of long 
COVID in participants and its characteristics, the clinical 
outcome, and the quality of life. The bivariate analysis will 
be performed using chi-square or fisher, to find the 
correlation between COVID-19 vaccination status and the 
characteristics and clinical outcomes of long COVID 
patients. The value of the limit of significance is 0.05. 
Data 
and 
Safety 
Monitoring Plan 
If there were any serious adverse events (SAE), the case 
will be reported to the ethics committee as soon as 
possible, less than 24 hours from the first time they were 
discovered, and actions were carried out as quickly as 
possible until the series of events ends. SAE was written 
in detail on the SAE form, including the following; when it 
was first discovered, the manifestation of the incident, the 
conditions before the incident, the handling of the event, 
and the outcome. 
 
 
 

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STUDY PROTOCOL 
1. 
Introduction 
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 the 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. 
2. 
Study Objectives 
2.1. 
Primary  
• To provide an overview of the symptoms and characteristics of Long COVID 
patients at Dr. Cipto Mangunkusumo General Hospital. 
• To 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. 
2.2. 
Secondary  
• To determine whether vaccination against SARS-CoV-2 could increase 
functional exercise capacity of Long COVID patients at Dr. Cipto 
Mangunkusumo General Hospital. 
• To determine whether vaccination against SARS-CoV-2 could reduce 
symptoms, duration, and frequency of Long COVID at Dr. Cipto 
Mangunkusumo General Hospital. 
 
3. 
Study Location 
Patient consent and data collection and analysis will occur at the hospital facility 
in Dr. Cipto Mangunkusumo General Hospital. 

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4. 
Study Duration and Timeline 
 
No. 
Activity 
Description 
Timeline 
1. 
Preparation and 
approval of the 
proposal 
Create and revise proposals and 
activity 
plans 
according 
to 
the 
discussions of the research team and 
collaborators 
September 2021 
2. 
Ethics approval 
Submit an ethical review to the health 
research ethics committee of FKUI-
RSCM 
October 2021 
3. 
Data 
collection 
phase I 
Collecting data from the patient's 
medical record 
November 2021 – 
December 2021 
4. 
Data 
collection 
phase II 
Collecting data from the online 
questionnaire, 6MWT, and follow-up 
March 
2022 
– 
November 2022 
5. 
Data analysis 
Data 
tidying, 
completing, 
and 
analysis 
December 2022 – 
February 2023 
6. 
Report writing 
Writing the final report on the results 
of the research 
March 2023 
7. 
Publication 
Publication of research results 
April 2023 
 
5. 
Methods 
5.1. 
Study Design 
This is a prospective cohort, cross-sectional study involving two hundred and 
fifty (250) subjects of post-acute COVID-19 patients, receiving outpatient/inpatient 
care from Dr. Cipto Mangunkusumo General Hospital during the acute phase of the 
infection, any time prior to enrollment in this study. 
 
 

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5.2. 
Study Population and Selection Criteria 
All participants will be required to sign a written informed consent, be willing 
and able to comply with all study requirements, and should meet the following criteria: 
1. Adult patients, aged ≥ 18 years old with a 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, any time prior to enrollment in this study 
2. Patients with/without comorbidities 
3. Willing to fill-out online Long COVID symptoms follow-up questionnaire 
4. Willing and able to comply with trial protocol (re-visits and physical testing) 
Subjects will be excluded from the study based on the following 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 
 
5.3. 
Recruitment Methods 
All patients, aged ≥ 18 years old with a 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 
(any time prior to enrolment in this study) are offered to be a participant in this study. 
One of the research team, dr. Andry Setiadharma will be examining the supervision of 
the primary investigator, dr. Eric Daniel Tenda, DIC, Ph.D., SpPD, and study 
coordinator, dr. Ni Nyoman Indira, SpPD. 
 
5.4. 
Data Collection 
Data on age, sex, height, weight, body mass index, income, education, 
comorbidities, smoking, alcohol consumption, documented SARS-CoV-2 vaccination 

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status (including the amount, type, and when the vaccine was received), detailed 
history of laboratory-confirmed SARS-CoV-2 infection, Long COVID symptoms, 
severity, and duration are collected through online screening questionnaire.  
Data on quality of life (QoL) are collected through St George's Respiratory 
Questionnaire (SGRQ) and Short Form (SF)-36 Health Survey self-assessment 
questionnaire at baseline, 3 and 6 months after enrollment. SGRQ addresses QoL in 
the domains of symptoms, activity, and impacts within the last 4 weeks; and the SF-
36 Health Survey questionnaire addresses QoL in the domains of vitality, physical 
functioning, bodily pain, general health perceptions, physical and emotional and social 
role functioning. 
Data on functional exercise capacity is measured using the Six-Minute Walking 
Test (6MWT) at baseline, 3 and 6 months after enrollment. The 6MWT is performed 
according to the guidelines of the American Thoracic Society (ATS). During the 6MWT, 
such data are collected: Blood pressure, oxygen saturation (SpO2), heart rate, 
dyspnea, and overall fatigue score using the Modified Borg scale before and after the 
test, and also one-time measurement (total distance walked in 6 minutes, symptoms 
at the end of exercise). 
5.5. 
Expected Outcomes 
It is the investigator’s expectation that vaccination against SARS-CoV-2 could 
improve clinical outcomes and quality of life; and reduce symptoms, duration, and 
frequency of Long COVID. 
5.6. 
Adverse Reactions 
There is no expectation of any adverse outcomes or reactions, should there be 
any adverse outcome or reactions, necessary management and will be taken in 
accordance with the standard medical protocol at the Dr. Cipto Mangunkusumo 
General Hospital. All participants will be given access to the contact information of the 
research team performing this study. Any adverse reactions will be reported 
immediately to the primary investigator or study coordinator. 
6. 
Potential Benefits and Risks 
The 6MWT is a safe test with rare complications. It is a practical, simple test 
that requires, in ideal circumstances, a 100-foot hallway, no exercise equipment, and 
no advanced training for technicians. Walking is a daily activity for all but severely 

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impaired patients and so can be used by most patients in a practice. Patient 
involvement is based on voluntary participation, is self-directed, and is easily 
terminated in the event of a complication. 
Safety considerations when administering the 6MWT include both technical and 
clinical aspects. Technical aspects for safety include proper training and knowledge 
for the person administering the test, adequate facility provision, and emergency 
provisions. Clinical aspects of safety considerations for the 6MWT include knowledge 
of absolute and relative contraindications and conditions requiring immediate 
cessation of the 6MWT. Study documentation of adverse effects reveals oxygen 
desaturation as the most common adverse effect, with desaturation to less than or 
equal to 80% in approximately 5% of testing, and patient symptoms prematurely 
terminating the test in 1% of testing. The absolute contraindications are unstable 
angina and/or myocardial infarction in the past 30 days. The relative contraindications 
are resting heart rate above 120 bpm, systolic blood pressure over 180 mmHg, and 
diastolic blood pressure above 100 mmHg. The reasons for cessation according to the 
ATS guideline are sudden chest pain, intolerable dyspnoea, leg cramps, staggering, 
diaphoresis, and pale or ashen appearance. 
We take extra effort during the study period to maximize patient safety. Fulfilling 
this goal, the study staff employs stringent procedures to reduce the risk of adverse 
events during the study period. 
 
7. 
Consent Process 
Approval for medical treatment is obtained by first briefly explaining the 
background, objectives, and benefits of the research. The informed consent must be 
fully explained by the investigator or member of the study staff including the study 
aims, methods, benefits, and risks, and signed by the subject before enrollment into 
the study. Potential subjects will be informed that study participation is voluntary and 
that they may withdraw at any time. The subjects will be told that choosing against 
participation will not affect the care received for treatment. The subjects will be 
informed that they will be authorized access by investigational staff to confidential 
medical records. The subjects will be given sufficient time to read the consent and ask 
any questions. Research participants who are willing to take part in this study then 
sign an informed consent. Patients who are willing to participate in the study will 
receive compensation. 

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8. 
Compensation 
The participants will accept the transportation fee of Rp100.000,00. 
9. 
Reasons for Withdrawal or Termination 
A subject may be discontinued from the study at any time if the subject or the 
investigator feels that it is not in the subject’s best interest to continue. The following 
is a list of possible reasons the subjects will be dropped out from the study: 
1. Participants withdraw their informed consent and refuse to participate in the study. 
2. Any contraindications for 6 Minute Walking Test according to the guidelines of the 
American Thoracic Society (ATS). 
3. Participants who died before the sixth-month follow-up. 
 
All subjects are free to withdraw from participation at any time, for any reason, 
specified or unspecified, and without prejudice. Reasonable attempts will be made by 
the investigator to provide a reason for subject withdrawals. The reason for the 
subject’s withdrawal from the study will be specified in the subject’s source documents 
and the Case Report Form (CRF). If a subject is withdrawn from treatment due to an 
adverse event, the subject will be followed and treated by the investigator until the 
adverse event has resolved or stabilized. 
 
10. 
Handling of Participant Withdrawals or Termination 
Although subjects may withdraw from the study at any time and for any reason, 
(or may be withdrawn at the investigator’s discretion), subject withdrawal should be 
avoided as much as reasonably possible. In any case, appropriate follow-up for 
withdrawals or termination. Subjects who are discontinued are not to be replaced. For 
subjects considered discontinued, the CRF must be completed up to the last visit 
performed. 
 
11. 
Privacy and Confidentiality 
Paper records for this study will be maintained in locked cabinets in Internal 
Medicine Departments. Electronic records for this study will be maintained on 
password-protected computers on which security is protected by firewalls. Files 
containing patient data will be stored in a locked office and/or on a password-protected 

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computer with access granted only to those individuals listed on the research team. 
Presentation of research results in scientific meetings/conferences and publications in 
scientific journals will not include participants’ identities. 
 
 
 
 
 

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STATISTICAL ANALYSIS PLAN 
 
1. 
Randomization 
Subjects who meet all inclusion and exclusion criteria will be allocated into four 
groups; Never been vaccinated, received 1st dose, received 2nd dose, and received 3rd 
dose of vaccination. Subject allocation will be carried out through block randomization 
and known only by the pharmacist, and confidentiality is maintained so that subjects, 
doctors/nurses, researchers, and data analysers do not know the allocation of each 
subject. 
 
2. 
Sample Size Calculation 
The sample size of this study is obtained from the two-way hypothesis testing 
formula for the two mean values in two independent groups with a confidence index 
(α) of 95% and power of 80%. Results are considered statistically significant if p < 
0.05. The details of the estimated size of the research subject are as follows: 
Descriptive study: Cross-sectional sampling 
𝑛= 𝑍𝛼
2  𝑃(1 −𝑃)
𝑑2
 = 1.962  0.4(1 −0.4)
0.12
  
n = 92,1 subjects ➔ 93 subjects 
Legends: 
N 
: Number of subjects 
Z 
: Z value in 95% confidence index = 1.96 
P 
: Long COVID prevalence according to literature = 0.40 
d 
: Standard deviation = 0.10 
 
Analytic study: Prospective Cohort, consecutive sampling method 
𝑛= (𝑍𝛼√2𝑃𝑄+ 𝑍𝛽√𝑃1𝑄1 + 𝑃2𝑄2
𝑃1 −𝑃2
)
2
= (1.96√2 𝑥 0.553 𝑥 0.447 + 0.80√0.653 𝑥 0.347 + 0.453 𝑥 0.547
0.20
)
2
 
n = 93 subjects → N = 186 subjects 
Legends: 
n 
: Number of subjects  
Z 
: Z value in 95% confidence index = 1.96 
Z 
: Z value of test power = 0.80 

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P1 − P2 
: Minimal difference in proportion considered significant = 0.20 (P1 = 0.653) 
Q 
: 1 - P 
 
Assuming a 20% loss to follow-up event, the final sample size is: 
n = 186 + (186 * 20%) 
n = 186 + 37 
n = 223 subjects 
 
3. 
Analysis methods 
3.1. 
Data entry 
Before entering data (data entry), the existing data is edited first to facilitate the 
stages of data entry. The data entry process goes through the coding process in the 
SPSS Statistics 20.0 program. 
 
3.2. 
Data analysis 
3.2.1. Univariate analysis 
The analysis is intended to obtain descriptive data regarding the incidence 
of long COVID events and the characteristic profile of long COVID patients. 
3.2.2. Bivariate analysis 
This analysis is used to see the relationship between the effect of the 
COVID-19 vaccine on clinical long COVID and the quality of life of long 
COVID patients. The level of significance used is 0.05. Variables are 
statistically significant if p-value <0.05. The independent variables in this 
study are nominal scale, so the test used in this analysis is the chi-square 
test or fisher's test (in the group of independent variables with a 
dichotomous scale of 2x2 if the chi-square does not meet the requirements. 
 
 
 

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4. 
Flow diagram 
 
 
Assessed for eligibility (n= ) 
Excluded (n=   ) 
   Not meeting inclusion criteria (n=  ) 
   Declined to participate (n=  ) 
   Other reasons (n=  ) 
Completed (n=  ) 
 All patients filled the online questionnaire 
 All patients did the six minute walking test 
 All patients had six months follow up 
Discontinued (n=  ) 
 Patient withdrew consent (n=  ) 
 Patient with contraindicated criteria (n=  ) 
 Patient with under six months follow-up (n=  ) 
Analysed (n=  ) 
 Excluded from analysis (incomplete data) (n=  ) 
Follow-Up 
Analysis 
Included (n=  ) 
Enrollment 

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INFORMED CONSENT FORM 
EXPLANATION SHEET FOR PROSPECTIVE SUBJECTS 
 
I am dr. Ni Nyoman Indirawati K, Sp.PD, member of the research team chaired by 
dr. Eric Daniel Tenda, DIC, Ph.D., Sp.PD, FINASIM from the Department of 
Internal Medicine. We will conduct a study entitled Characteristics and Effects of 
COVID-19 Vaccination on Clinical and Quality of Life of Long COVID Patients at 
Dr. Cipto Mangunkusumo General Hospital. 
We invite you to take part in this study, which seeks to get an overview of the 
characteristics of long COVID patients at Dr. Cipto Mangunkusumo National Central 
Public Hospital as well as to assess the effectiveness of the COVID-19 vaccine against 
long COVID symptoms and the quality of life of long COVID patients. Taking part in 
this study is entirely voluntary. We urge you to discuss any questions about this study 
with our staff members. Talk to your family and friends about it and take your time to 
decide. 
If you choose to participate, you must sign this form to show that you want to 
participate. If you refuse to participate or withdraw from this research, that decision 
will not affect your affiliation with me. Furthermore, it will not affect the services that 
apply at this hospital. 
If you do not understand each statement in this form, you can ask us about it. 
 
1. Research objectives 
To get an overview of the characteristics of long COVID patients at Dr. Cipto 
Mangunkusumo National Central Public Hospital from May 2021 to December 2021, 
as well as to assess the effectiveness of the COVID-19 vaccine against long covid 
symptoms and the quality of life of long COVID patients. 
 
2. Participation in research 
Overall, the study will run for six months. If you are willing to participate in this 
research, you will follow the schedule and ensure that you can follow the plan. This 
research will involve filling out an online questionnaire and conducting a 6-minute walk 
test (6MWT) in the 3rd and 6th months. 
 
3. Participants’ criteria 
1. Age 18 years old and above. 
2. Patients who are confirmed positive for SARS-CoV-2 through molecular 
examination (RT-PCR SARS-CoV-2, Naso-oropharyngeal swab) or antigen 
(lateral flow assay) at least two months before recruitment; or have received a 

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diagnosis of a previous or confirmed clinical COVID-19 patient (has received 
treatment in a hospital with a diagnosis of COVID-19; any time before 
recruitment as a research subject). 
3. Patients with or without comorbidities: diabetes mellitus, hypertension, 
tuberculosis, asthma, chronic obstructive pulmonary disease, chronic kidney 
disease, heart disease, chronic liver disease, malignancy, nervous system 
disease, psychiatric disorders, elderly patients, and patients with physical 
impairment or disability. 
 
4. Research procedure 
 4a. Intervention procedure 
1. The research team will explain the purpose and procedure of this research. 
2. Fill out the online questionnaires or via your mobile phone. 
3. The research team will collect your clinical, laboratory, and radiological data 
through medical records. 
4. In the 3rd and 6th months, you will do a walking test for 6 minutes. You will walk 
as far as possible for 6 minutes on a specific track/area under the supervision of 
the research team. 
 4b. Currently available alternative procedures or treatments 
None. 
 
5. Risks, side effects, and management 
There were no clinical risks or side effects in this study because there was no 
intervention or treatment. 
There is a risk of leakage of your medical record data. However, the research team 
will minimize that risk through direct data handling and processing and a password to 
protect patient data. 
 
6. Benefits 
The benefits you can get are that you get information about your general condition 
after COVID-19 infection and a fitness check through a 6-minute walking test for free. 
 
7. Compensation 
You will receive a transportation fee of Rp. 100,000. 
 
 
 

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8. Financing 
The researcher will entirely bear the funding for this research. 
 
9. Confidentiality 
The research team will handle and process data directly by the data, and a password 
will protect the participants’ data. Presentation of research results in scientific 
meetings/conferences and publications in scientific journals will not include your 
name. 
 
10. Obligations of research subjects 
As research subjects, you must follow the rules or research instructions as written 
above. If something is not clear, you can ask the research team further. 
 
11. Right to refuse and withdraw 
You do not have to participate in this research if you don't want to. However, you must 
understand that even if you agree to participate, you have the right to withdraw from 
this research. If you refuse to participate or withdraw from this research, that decision 
will not affect your relationship with the researcher. I will allow you to consider the 
decision at the end of this explanation. 
 
12. Post-trial access 
There were no interventions or treatments in this study. 
 
13. Additional Information 
You can ask all things that are unclear in connection with this research. Suppose at 
any time you need further explanation. In that case, you can contact dr. Ni Nyoman 
Indirawati K, SpPD at the Department of Internal Medicine, Division of Respirology 
and Critical Illness Dr. Cipto Mangunkusumo National Central Public Hospital Jakarta 
with phone number +6281390705913. 
 
 
 

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RESEARCH PARTICIPATION APPROVAL SHEET 
 
I have received all the explanations and dr. Ni Nyoman Indirawati K, Sp.PD has 
answered all my questions. I understand that if I need an explanation, I can ask dr. Ni 
Nyoman Indirawati K, Sp.PD. 
Certificate of Approval 
I have read all the descriptions of this 
research. 
Furthermore, 
I 
had 
the 
opportunity to ask questions and the 
research 
team 
answered 
all 
my 
questions. Therefore, I am willing to 
participate 
in 
this 
research 
study 
voluntarily. 
I confirm that participants are allowed to 
ask questions about this study and that 
all questions have been answered 
correctly. Furthermore, I confirm that 
consent has been given voluntarily. 
 
 
_____________________________ 
 
 
_____________________________ 
Name of participant/guardian 
 
 
Name of researcher 
 
 
_____________________________ 
_____________________________ 
Signature 
 
Signature 
 
Date _________________________ 
day/month/year 
Date _________________________ 
day/month/year 
 
 
 
Researcher Information: 
Principal Researcher:  
dr. Eric Daniel Tenda, DIC, Ph.D, Sp.PD, FINASIM 
Department of Internal Medicine, Division of Respirology and Critical Illness Dr. Cipto 
Mangunkusumo National Central Hospital, Jakarta. 
+62 81380333818 / eric.tenda@ui.ac.id 
 
 

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Researcher:  
dr. Ni Nyoman Indirawati K, Sp.PD. 
Department of Internal Medicine, Division of Respirology and Critical Illness Dr. Cipto 
Mangunkusumo National Central Hospital, Jakarta. 
+62 81390705913 / ninyoman.indira@gmail.com 
KEPK FKUI-RSCM: 
Jalan Salemba 6, Central Jakarta, 10430 
021 3157008 / ec_fkui@yahoo.com 
 
 

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If the subject is illiterate: 
An illiterate participant must sign it (if possible, this person should be selected by the 
research subject/participant, not their parents, and must not have any relationship with 
the research team). Illiterate research subjects/participants must also include their 
fingerprints. 
I have witnessed the accurate reading of the consent form to the research 
subject/participant and have been allowed to ask questions. I confirm that the 
subject/participant has given their free consent. 
Participant's name ___________________  
AND Participant’s fingerprint 
 
 
Signature 
________________________ 
Date  
________________________ 
Date/Month/Year 
 
 

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For young children, older subjects, or subjects who, because of their capacity, cannot 
give consent (vulnerable subjects), the participant's parents, children, husband/wife, 
or legal guardian must request permission. 
In general, there are several sentences on the information sheet and participation 
agreement sheet that must be adjusted to the conditions, for example: 
"The research team invites son/daughter/father/mother/husband/wife of [guardian] to 
participate in this research. This study requires approximately [number of] research 
subjects, with the participation period of each subject being approximately [period of 
study]." 
 
 
 

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APPROVAL SHEET 
 
The patient,   
 
, will participate in the research: Characteristics and 
Effects of COVID-19 Vaccination on Clinical and Quality of Life of Long COVID 
Patients at Dr. Cipto Mangunkusumo National Central Public Hospital. I have 
read and understood the information in the information sheet and have been allowed 
to discuss and ask questions about it. I agree to allow my child/father/mother to get 
involved in this research. I understand that I may refuse to participate in the research. 
I know I can withdraw from this study any time I wish. I understand that if I do not 
participate in this study, my child/father/mother will still receive proper medical care 
according to the patient's illness/condition. 
I, as a PARENT/GUARDIAN of __________________, AGREE to participate in this 
research. 
Date: __________________ 
 
Signature of Parent/Guardian:  
_____________________ 
Name of Parent/Guardian:  
_____________________ 
 
Witness Signature: ____________________ 
Witness Name: 
____________________