Dubai College of Pharmacy

FORMAT FOR SUBMISSION OF RESEARCH PROPOSAL

(For Student Research Projects)

Evaluation of Cytokine Storm Treatment in Covid-19 Patients after Vaccination at a General

Hospital Jakarta

1 Student Name(s) & Registration number(s):

Nindi Arnanda

1843050082

Programme: Bachelor in Pharmacy

2 Supervisor
3 Co-supervisor (s)
4 Name (s) of collaborating
Institution/Department (s)
Name: Dr. Apt. Diana Laila Ramatillah, M. Farm.
Designation: Associate Professor
Department: Department of Pharmacy
Name: Dr.Kishore Gnana Sam
Designation: Associate Professor
Department: Department of Pharmacy

Enclose permission letter (s)

Signature of Student(s) - ____________________________; _____________________________;

_____________________________; ______________________________;_____________________

Signature of Supervisor - _________________________

Signature of Co- Supervisor - 1 ________________________

Signature of Co- Supervisor - 2 ________________________

Signature of Statistician - _________________________

I have gone through the research proposal. The study has been designed to obtain only information
relevant to the project and no ethical issues have been identified.

Signature of the Head of the Department/Dean:-___________________________________________

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Researcch Proposal

1.Title:
Evaluation of Cytokine Storm Treatment in Covid-19 Patients after Vaccination at a General
Hospital Jakarta

2. Background :
These cytokine storms are extremely dangerous. Cytokine storm is considered the reason for
the high mortality rate of COVID 19 patients. There is undetected reason causes a Cytokine
storm in a patient, but this is associated with the characteristics of a person's immune
system. (Azkure, AK. 2020) The limits of data and research about cytokine storm causes
inhibition of preventing and treatment for COVID 19 patient with cytokine storm.
Vaccination expected to reduce the risk of COVID-19 patients being exposed to cytokine
storms or alleviate the cytokine storm symptoms among COVID 19 patient. (Chung, JY. 2020)

4. Rationale:
The limits of data about cytokine storm causes inhibition of preventing and treatment this
dieseases. This study will evaluating the cytokine treatment in COVID 19 patient after recive
the vacctination, will there be any difference or alleviate the symptoms about the cytokine
storm among COVID 19 patient.

5. Research Question:
The research question of this study Is vactination causes any difference or alleviate the
symptoms of cytokine storm among COVID 19 patient and is the treatment of cytokine storm
among COVID 19 patient used in the general hospital in jakarta was effective? And is there
any correlation between the treatment used with the clinical outcome among COVID 19
patient with cytokine storm experience.

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5. Objectives:
This study expected to evalueting the Cytokine Storm treatment in Covid-19 Patients after
Vaccination at Jakarta General Hospital. To evaluate the treatmen given and the clinical
outcome among COVID 19 patient with cytokine storm symptoms.

6. Conceptual/Operational definitions:

Get the Get Approve from

Research clinical clearence the hospital to take
Planning and from the Data (patient
Proposal UTA’45 Commite Medical record)

Transfer data into Selectide all patient Analysis the

collection Data with cytokine storm Medical record of
Form and Analysis who suitable in the the COVID 19
the Data criteria patient

Picture 1. Chart Flow

COVID 19
The Coronavirus Disease 2019 (COVID-19) is a global health problem, on March 10, 2020
WHO declared that the world was experiencing a pandemic. As of today, October 15, 2021,
there were 239,437,517 confirmed cases of COVID-19, including 4,879,235 deaths, reported
to WHO. (WHO,2021) The Coronavirus Disease caused by the SARS-CoV2 virus causes infects
the lower respiratory tract and causes pneumonia in humans, with symptoms that appear
milder than SARS or MERS infection, but ultimately becomes a lethal disease of
hyperinflammation and respiratory dysfunction. (Chen,G. 2020)

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Cytokin storm
most of the COVID-19 patients recover with mild and moderate disease in one week, some
develop to severe pneumonia in the second week followed by cytokine storm, ARDS,
multiiorgan failure, and disseminated intravascular coagulation (DIC) within the 3rd week of
the disease. (Ye Q. 2020) The high mortality rate in COVID-19 patients is most likely due to
the occurrence of a cytokine storm in the patient's body. Cytokines are immune
inflammatory proteins that function to ward off infection and tame cancer cells in the body.
Cytokines also immune system proteins that regulate interactions between cells and trigger
immune reactivity, both in innate and adaptive immunity. (C, Wang. 2020) Cytokine Storm
also known as Cytokine Release Syndrome (CRS) or Cytokine Storm Syndrome (CSS) is the
occurrence of Systemic Inflammatory Response Syndrome (SIRS) which can be triggered by
various factors; and one of them is infection by a virus. (Yongzhi, X. 2021) If the incoming
virus is new (there is no memory in the immune system) and the pathogenic power is high;
Thus, the release of cytokines tends to be uncontrolled. Itoccurs when a large number of
white blood cells are activated and release inflammatory cytokines. Cytokine production
becomes rapidly dysregulated, damaging healthy cells typically first in the lungs but
potentially spreading to other organs including the kidneys, heart. (Bhaskar, S. 2020)

Vaccination
Vaccination or immunization aims to accelerate immune system able to recognize and
deactivate bacteria or viruses that cause infection. The goal to be achieved by giving the
COVID-19 vaccine is to reduce morbidity and mortality due to this The Coronavirus Disease
2019. vaccination aims to encourage the formation of herd immunity.

7. Materials & Methods

7.1. Research design:

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The study used the cohort method, a retrospective cohot study using historical patient
record. The subject of this studY is all vaccinated COVID 19 patient in a General Hospital
Jakarta who was treated due to the cytokine storm of COVID 19.

7.2. Study population:

Inclusion criteria: Vaccinated COVID 19 Patient with Cytokine storm experience, Patient
above 18 Years old, COVID 19 Positive Patient who recieved COVID 19 treatmen
(Antiviral/Antibiotic) therapy between March 2020 – September 2021.
Exclusion criteria: Patient below 18 years old, Patient with Cancer, Pregnant Women Patient,
Patient with SIE, SLE, and SLU.

7.3. Sample size calculation:

The sample sixe calculation of this study is using a convinience sampling method, witch mean
using all the data of COVID 19 patien who suitable in the criteria of this study. (minimum 300
data)

7.4. Study settings:

General Hospital ini Jakarta, Indonesia (St. Carolus General Hospital)

7.5. Duration of study:

6 month

7.6. Study instrument & validation procedure:

This study instrument using analysis data historical patient record form the general holspital
Jakarta (tranfer it to data colection form)

7.7. Ethical issues:

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No ethical issues were identified. All study participants are expected to be benefitted.
Study will begin only after Ethics Committee Approval and consent will be taken from
patients. Confidentiality will be maintained for patient identifiers.

7.8. Methodology:
This research using retrospective cohort study to evaluate and analysis the cytokine storm
treatment in Vaccinated Covid-19 patients in general hospital Jakarta with convinience
sampling method. The research will colecting data historical patient record and evaluating all
the variable to selecting data so suitable in the criteria of this study. The variable of this
reseach are gender, age, BMI, comorbidity, complication, duration of treatmen, stage, the
treatmen (Antiviral/Antibiotic), vital sigh, clinical sigh, and clinical outcome from vaccinated
COVID 19 patient. The convinience sampling methode used to select the suitable criteria of
this study.

7.9. Feasibility of the proposed research

This reserch study is feasible because there is still lack of research on the evaluation of
cytokine storm treatment.

7.10. Details of data storage :

The data will be stored for a period of 5 years in the College of Pharmacy office at
University of “17 Agustus 1945” Jakarta. Precautions will be taken not to leak data to
unintended sources other than presentation or publication or to the Ministry of Health or
the collaborating hospitals on request. No information patient identifiers will be shared
to any third party. Results after data analysis will be presented in conference and
published in an appropriate journal.

7.11. Data analysis :

Using statitical analysis

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7.12. Time line :

Items October Oktober November December January –
2021 2021 – 2021 – 2021 – March 2021
November Desember January
2021 2021 2022
PLANNING

DATA
COLLECTION
DATA
ANALYSIS
DRAFT REPORT
AND
PRESENTATIO
N
FINAL REPORT
AND BEGIN
PUBLICATION
PROCESS

8. Expected outcome:
This study is expected to reader about evaluation and analysis of cytokine storm treatmen in
vaccinated COVID 19 patient in general hospital jakarta, is there any will there be any
difference or alleviate the symptoms. This study also expected to be a reference to all
medical personal for treating the cytokine storm in vaccinated COVID 19 patient.

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9. References according to Vancouver style:

Wang, jin. Cytokine Storm and Leukocyte Changes in Mild Versus Severe SARS-CoV-2
Infection: Review of 3939 COVID-19 patients in China and Emerging Pathogenesis and
Therapy Concepts. Macau,China. Journal of Leucocyte Biology (JLB). 2020. (17 -41)
Available from: https://pubmed.ncbi.nlm.nih.gov/32534467/

Metha, P. COVID-19: Consider Cytokine Storm Syndromes and Immunosuppression.

London,UK. Elsevier. 2020. (vol. 395 1033-1034)
Available from:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30628-0/fulltext

Azkure, AK Et Al. Immune Response to SARS-CoV-2 and Mechanisms of Immunopathological

changes in COVID-19. Wolfang, Switzerland. EAACI and Jhon Wiley and Son A/S. 2020. (1564-
1581)
Available from: https://pubmed.ncbi.nlm.nih.gov/32396996/

Bhaskar, S. Cytokine Storm in COVID-19—Immunopathological Mechanisms, Clinical

Considerations, and Therapeutic Approaches: The REPROGRAM Consortium Position Paper.
Madrid, Spain. Frontiers In Immunology. 2020. (Vol. 11 1-16)
Available from: https://www.frontiersin.org/articles/10.3389/fimmu.2020.01648/full

p2019. Wuhan, China. Journal of Clinical Investigation (JIC). 2020. 130(5):2620-2629.

Available from: https://www.jci.org/articles/view/137244/pdf

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Ye Q. The pathogenesis and treatment of the `Cytokine Storm' in COVID-19. Huangzou,

China. Elsevier J Infect. 2020. 80(6):607-613.
Available from: https://doi.org/10.1016/j.jinf.2020.03.037

Wang, C. Alveolar Macrophage Dysfunction and Cytokine Storm in the Pathogenesis of Two
Severe COVID-19 patients. Shanghai, China. EbioMedicin Published by Lancet. 2020. (Vol. 57
102865)
Available from: https://doi.org/10.1016/j.ebiom.2020.102833

Yongzhi, X. COVID-19-Associated Cytokine Storm Syndrome and Diagnostic Principles: an Old

and New Issue. Beijing, China. 2021. EMERGING MICROBES & INFECTIONS. 2021. (Vol 10.
266-276)
Available from: https://www.tandfonline.com/doi/full/10.1080/22221751.2021.1884503

WHO, WHO Coronavirus (COVID-19) Dashboard. 2021

Available from: https://covid19.who.int/

Chung, JY. COVID-19 Vaccines: The Status and Perspectives in Delivery Points of View. -
Elsevier Advanced Drug Delivery Reviews. 2021 (Vol 170. 1-25)
Available from: https://doi.org/10.1016/j.addr.2020.12.011

10. Consent form:

11. Draft Questionnaire:
12. Budget:
No financial support is requested. The services provided to patients as a part of this study are
free.

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