Online International Symposium on Clinical Research (Trials)
Theme:
International Clinical Research (Trials) during COVID-19 era:
- Should we suspend or continue? -Day 1: March 11, 2021 15:25 – 18:40 JST (06:25 - 09:40 UTC)Day 2: March 12, 2021 15:25 – 17:55 JST (06:25 – 08:55 UTC)March 11, 2021

Day 1:March 11, 2021

15:25

16:25 – 16:45(10:25 -10:45 Nairobi)

Opening
Moderator: Marlinang Siburian, NCGM/DIT
Opening Remarks
Norihiro Kokudo (President, NCGM)
Developing and maintaining an international clinical trial network activity.
Tatsuo Iiyama (Director, Department of International Trials)
The New normal for Clinical research (trials).
Chair: Hamana Mieko, NCGM/DIT
Co-chair: Muchanga Sifa, NCGM/DIT
Impact of COVID-19 on Infectious diseases research (trials)
Norio Ohmagari (Director, Disease Control and Prevention Center, NCGM)
Impact of COVID-19 on cancer clinical trials
Kenichi Nakamura (Director, National Cancer Center)“Clinical trials in resource limited settings: An example of Leishmaniaisis East Africa Platform (LEAP).
Monique Wasunna (Director, Drugs for Neglected Diseases Initiative, Africa Regional Office)Keynote speech
16:45 – 17:15(8:45 – 09:15 Paris)

Impact of the COVID-19 pandemic on the management of the Intensive Care and the battle of
implementing treatment for a new and unknown disease.
Mehran Monchi, (Head of Department of Intensive Care Medicine, Melun General Hospital, France)

17:15- 17:35

Clinical Research between Thailand and Japan in orthopedics
Tsuyoshi Murase (Division of Medicine, Graduate School of Medicine, Associate Professor, Osaka
University)
Collaborative study of Prospective, MUlticenteR, Observational StUdy of the PatIenTs with Heart
Failure with Preserved Ejection Fraction (PURSUIT HFPEF) between Japan and Cambodia
Daisaku Nakatani (Head of Global Clinical Research Support Group, Department of Medical
Innovation, Osaka University Hospital)
Malaria elimination during COVID-19 era
Srivicha Krudsood (Professor, Department of Tropical Hygiene, Mahidol University)
Clinical trials for devices and IVD other than COVID-19 device -Malaria
Shigeyuki Kano (Director, Department of Tropical Medicine and Malaria, Research Institute, NCGM)
Wrap up

15:30 – 15:35
15:35 –15:45
Session 1
15:45 – 18:40
15:45 –16:05
16:05 –16:25

17:35- 17:55

17:55- 18:15(15:55 – 16:15 Bangkok)
18:15 -18:35
18:35 – 18:40

OPENING
Opening Remarks
Norihiro Kokudo (President, NCGM)

Developing and maintaining an international clinical trial network activity.
Tatsuo Iiyama (Director, Department of International Trials)

Session 1: 15:45 – 18:40
The New normal for Clinical research (trials)
Chair: Hamana Mieko, NCGM/DIT
Co-chair: Muchanga Sifa, NCGM/DIT

Abstract
Impact of COVID-19 on Infectious diseases research (trials)

Short CV
Dr. Norio Ohmagari is acting as Director, AMR Clinical Reference Center and Director,
Disease Control and Prevention Center of National Center for Global Health and Medicine(NCGM), Japan.
Dr. Ohmagari has completed his clinical fellowship in Infectious Diseases at University ofTexas-Houston. After serving as chief of the Division of Infectious Diseases at the Shizuoka
Cancer Center, in 2011 Dr. Ohmagari moved to NCGM which is one of six national medical
centers in Japan with infectious diseases as main objective.
At NCGM, Dr. Ohmagari has been acting as Director of the Disease Control and Prevention
Center since 2012. He also serves as the director of AMR Clinical Reference Center, which iscommissioned by Ministry of Health, Labor and Welfare, Japan.
Dr. Ohmagari is engaged in the care, prevention and research of infectious diseases from a
global perspective. As a physician, Dr. Ohmagari is directly involved in the clinicalmanagement of patients with infectious diseases.
Dr. Ohmagari is also actively working on activities with controlling antimicrobial resistance inJapan. At the same time, Dr. Ohmagari is working on the on-site response in infectious diseasecrisis management in Japan.

In the event of an outbreak of an emerging infectious disease,
it is important to collect clinical information as soon as possible and to conduct research anddevelopment of therapeutic agents.
In order to conduct research and development promptly,
it is necessary to conduct international joint clinical trials in order to secure the number ofcases and to promote research and development in multiple countries.
During the COVID-19 epidemic, we have conducted several international collaborative trials
with NIH and faced this difficulty.
The first clinical trial (ACTT-1) was our first international clinical trial, but thanks to the
NIH team coming to Japan in February 2020, the preparation for the clinical trial went verysmoothly and we were able to start the clinical trial in Japan within one month of the start ofpreparation.
For the second trial, the ITAC trial, all the preparations for the start of the trial were done
remotely, as the pandemic had already prevented us from communicating with the research
network team in Australia. A number of challenges arose during the preparation phase, someof which may have been due to the fact that the preparation had to be done remotely.
The experience of the clinical trials under COVID-19 is expected to change the way
international clinical trials are conducted in the future.

Session 1: 15:45 – 18:40
The New normal for Clinical research (trials)
Chair: Hamana Mieko, NCGM/DIT
Co-chair: Muchanga Sifa, NCGM/DIT

Abstract
Impact of COVID-19 on cancer clinical trials

Short CV
Dr. Kenichi Nakamura, is the Director of the Department of International ClinicalDevelopment at the National Cancer Center Hospital in Tokyo.
He holds a PhD in Medicine from Kyoto University.
His expertise is on Clinical Trial Methodology, Clinical Trial Operation, Clinical Trial
Regulation.
He provides comprehensive support activities to ensure the smooth implementation of highquality oncologic studies in Japan and overseas.
He is the Board member of the Japanese Society of Clinical Trials and Research and theVice-chairman of the Institutional Review Board in the National Cancer Center.
He is well published in peer review journals mainly on cancer research.

Japan Clinical Oncology Group has about 50 ongoing clinical trials and the patient accrual
speed slowed down temporarily after the outbreak of COVID-19. The monthly patient
accrual on May and June decreased by 10-20%, but got back to normal soon after that.
While the patient accrual of industry-sponsored global trials were seriously impacted by
COVID-19, the impact on Japanese academic cancer trials was limited.
The largest impact of COVID-19 on cancer trials is difficulty to visit participating site formonitoring/audit.
Since many institutions restricted site visit monitoring/audit during the state of emergency,
industry- and academic sponsors have started to pursue remote-monitoring, but theprocedures have not yet been standardized well.
In fact, various methods are being tested such as telephone call, online video filming ofelectric health record (EHR) and direct access on EHR.
Now that ICH-E6 is being amended globally and flexible monitoring is supposed to beallowed in the amendment, we should consider how we can assure the data reliability
without relying on intensive on-site monitoring.
In response to the pandemic, PMDA has issued such notification as direct drug shipping topatient’s home, online check-up, contract enabling external sites to perform a part of the
protocol treatment; however, most of them were difficult to be utilized in cancer clinical
trials.

Session 1: 15:45 – 18:40
The New normal for Clinical research (trials)
Chair: Hamana Mieko, NCGM/DIT
Co-chair: Muchanga Sifa, NCGM/DIT

Abstract“Clinical trials in resource limited settings: An example of Leishmaniaisis East Africa
Platform (LEAP)

Short CV
Dr. Monique Wasunna is the Director, Drugs for Neglected Diseases Initiative Africa
Regional Office.
She is a physician, an infectious disease and tropical medicine specialist.
She is the Founding Chairperson of the Leishmaniasis East Africa Platform which promotes
clinical research and capacity building for this neglected and deadly disease.
Prior to joining DNDi, Dr Wasunna worked at the Kenya Medical Research Institute where
she rose from the position of an Assistant Research Officer to that of the Acting Director andChief Executive Officer.
She holds a Bachelor of Medicine and Surgery degree from the University of Nairobi, an
MSc and a PhD in medicine from the London School of Hygiene and Tropical Medicine anda diploma in Tropical Medicine and Hygiene from the Royal College of Physicians of
London.
She is a former member of the International Bioethics Committee of UNESCO.
She is well published in peer review journals.

DNDi is a patients’ needs driven, not-for-profit research and development (R&D)
organization that develops safe, effective, and affordable medicines for neglected diseases
afflicting millions of the world’s poorest people.
DNDi’s R&D pipeline encompasses a full range of drug development, from early researchand preclinical through to phase I, II, III and IV clinical trials (CTs) for diseases such as
African sleeping sickness, leishmaniasis, Chagas disease, filarial diseases, mycetoma as wellas paediatric HIV and hepatitis C.
Clinical trials are critical in providing evidence of efficacy and safety of innovation.
CTs are specialized studies that are highly regulated by international and national laws toensure safety of study participants and the attainment of credible data for registration andpolicy change. DNDi has extensively worked with partners to conduct CTs in Low-andmiddleincome countries (LMICs) carrying the highest burden of neglected diseases.
Clinical research platforms such as the Leishmaniasis East Africa Platform (LEAP), created
by DNDi, have been fundamental in identifying patients’ needs, R&D gaps, strengthening
and sustaining clinical research capacity and facilitating access to new treatments. Since
inception, LEAP has carried out eleven CTs and delivered treatment options for visceralleishmaniasis patients. Building CTs research capacity, knowledge sharing, and infrastructure
improvement are key requirements in LMIC countries for success. Challenges in carrying out
CTs in LMIC include fragmented capacity, different cultures and regulatory environments,
long periods of ethics review and civil unrest. COVID-19 pandemic has impacted theongoing CTs. Measures have been put in place to mitigate this impact.

Session 1: 15:45 – 18:40
The New normal for Clinical research (trials)
Chair: Hamana Mieko, NCGM/DIT
Co-chair: Muchanga Sifa, NCGM/DIT

Abstract
Impact of the COVID-19 pandemic on the management of the Intensive Care and thebattle of implementing treatment for a new and unknown disease.

Short CVDr Mehran Monchi is the Head of the Department of Intensive Care Medicine at Melun
General Hospital in Paris.
Prior to joining Melun General Hospital, He has been working at different University
Hospitals of France and Belgium.
He holds a Bachelor Degree from Medical University of Grenoble in France and two
postgraduate Diploma; one in Endocrinology and Metabolism from Necker University Paris
V and another in Intensive care Medicine from Paris-Sud University.
He also holds a Master of Science in Biology and Technology of artificial Nutrition.
His research focus mainly on: Renal Replacement Therapies (and Regional citrate
anticoagulation), Cardiac arrest, Inhaled anesthetics in intensive care, and Infectious diseases.
He is well published in peer review journals with 5 publications last year.

Located in the greater Paris area and supporting around 500 000 inhabitants, our ICU
includes 22 beds allowing mechanical ventilation and 12 step-down beds.
During the two “waves” of the Covid-19 pandemic in France, we were able to increase thecapacity up to 60 ICU beds. We used large stocks of personal protective equipment secured
inside our hospital since the 2009 influenza pandemic.
The ICU staff contamination by Covid-19 was about 20%, including extra hospital
contaminations. The ICU team was strengthened by Anesthesiologists, medical students,
operating room nurses and student nurses.
The main clinical challenges during the first wave of an unknown disease were unusual
very sticky secretions plugging tracheal tubes, a very high frequency of pulmonary thrombo
embolism, low antibiotic levels in the lung of mechanically ventilated Covid-19 patients,
episodes of bacteremia due to digestive ischemia, sedative drugs shortage and the lack ofeffective antiviral treatment for severe patients. Some of these issues have been resolved bypragmatic approaches.
During the two waves, we made some studies on steroids, sedative drugs, non-invasive
ventilation, anticoagulation and anti-inflammatory drugs for Covid-19.
The media coverage of the disease was very focused on some topics such ashydroxychloroquine, advocated by the presidents of the USA and Brazil, without a clear
scientific basis and inducing requests by the patients’ proxies. Emotional stress and teamburnout were frequent during the two waves.
After the two waves, some ICU nurses wished to no longer work in the ICU, but also, somestudents discovered the ICU and wished to come back after graduation.

Session 1: 15:45 – 18:40
The New normal for Clinical research (trials)
Chair: Hamana Mieko, NCGM/DIT
Co-chair: Muchanga Sifa, NCGM/DIT

Abstract
Clinical Research between Thailand and Japan in orthopedic

Short CV
Dr. Tsuyoshi Murase, is an Associate Professor and Vice Chairman of the Department ofOrthopaedic Surgery, Osaka University Graduate School of Medicine.
He specializes in hand and upper extremity surgery.
He is also involved in research on computer simulation surgery, which he has beendeveloping for the past 20 years with a continuously awarded public research grant. He has
been working on international collaboration with other Asian countries.
He holds a PhD on Orthopedics surgery and has been resident at Osaka University and at
Institut Francais de la Main.
He has served on the executive board of the Japanese Society for Surgery of the Hand and as
editor of major journals.
He is member of many scientific societies including the Japanese Orthopaedic Association,
the American Society for Surgery of the Hand, the Japanese Society for Surgery of the Hand,
etc.
He is well published in peer review journals

Fractures around the forearm and elbow often heal in a deformed state. The resulting
deformity of the limb can cause pain, range of motion impairment, and instability in adjacent
joints, interfering with activities of daily living. Although accurate correction has bendifficult to achieve with conventional surgical techniques.
We have been developing a surgical method of correcting upper limb deformity using apatient- specific surgical guide and osteosynthesis plate that enables accurate surgery basedon preoperative computer simulation. After achieving excellent results in clinical trials inJapan, we have been conducting joint studies with Thailand with the aim of expanding ourtechnology overseas.
Based on the MOU between Osaka University and the Thai Ministry of Public Health, aclinical study plan was designed, and with financial support from Japan’s AMED, a series of
on-site demonstration surgeries and cadaver trials have been conducted.
Due to the digital technology-based nature of this treatment, online approaches are
particularly suitable. Image data is sent online from Thailand, and preoperative simulation,
design, and manufacturing are performed in Japan. To further facilitate communication
between the two countries, we are building a dedicated cloud system called “Bone Cloud”.
The system is equipped with online data transfer functions, 3D viewing of simulations, andcommenting functions, allowing advanced treatment planning to be carried out like a social
networking service.
Given the restrictions on local activities due to the spread of coronavirus infections, online
and cloud-based approaches will become even more important.

Session 1: 15:45 – 18:40
The New normal for Clinical research (trials)
Chair: Hamana Mieko, NCGM/DIT
Co-chair: Muchanga Sifa, NCGM/DIT

Abstract
Short CV
Dr. Daisaku Nakatani is a Specialized Associate Professor in both the Department of
Cardiovascular Medicine and Medical Innovation at Osaka University.
He is the head of the Global Clinical Trial Support Office, Department of Medical Innovation.
He has been striving and leading his Department to create academe-initiated clinical research
projects for local and international settings. He aims at minimizing the lag concerning theaccess of pharmaceuticals, medical devices, and regenerative medicinal products between
neighboring countries and Japan.
Prior to joining his current position, He has been working as an officer of the advanced
medical service system for the Ministry of Health, Labor and Welfare where He contributed
to get approval for huge number of clinical trials with specified medical care coverage under
the advanced medical service system.
He holds a PhD on Epidemiology and Preventive Medicine for cardiovascular disease from
Osaka University and worked as Postgraduate fellow at Stanford University, Center for
Cardiovascular Technology.
He is well published in peer review journals with 10 publications since last year.

Collaborating study of Prospective, MUlticenteR, Observational StUdy of the
PatIenTs with Heart Failure with Preserved Ejection Fraction (PURSUIT HFPEF)
between Japan and Cambodia.
Heart failure with preserved ejection fraction (HFpEF) is recognized worldwide as adifferent aspect of heart failure to that with reduced ejection fraction (HFrEF) and accounts
for more than 50% of all heart failure patients.
To date, there are no established treatment strategy to improve outcomes in patients with
HFpEF, unlike the case of HFrEF. In order to clarify patient characteristics, treatment andlong-term outcomes in patients with HFpEF, we have organized HFpEF registry with anaffiliated 30 hospitals of Osaka University Hospital in Japan since 2016. As of end of
February 2021, more than 1,500 patients were enrolled to the registry.
Using the registry data, we have shown that elevated N-terminal pro-brain natriuretic
peptide (NT-proBNP) level at the convalescent stage was associated with an increased riskof one-year outcomes in patients with HFpEF, suggesting that NT-proBNP guided therapy inclinical practice may be helpful to improve outcomes for HFpEF.
In Cambodia, cardiovascular disease is among the leading causes of death. Furthermore, itappeared health insurance system has not been well disseminated across the country. We
believe that collaborating registry study of HFpEF between Cambodia and Japan may
contribute to improve health care and clinical practice, leading to improve quality of life aswell as life-expectancy in both countries. Therefore, we are now starting to prepare thecollaborating study. In this meeting, we would like to introduce and share our project.

Session 1: 15:45 – 18:40
The New normal for Clinical research (trials)
Chair: Hamana Mieko, NCGM/DIT
Co-chair: Muchanga Sifa, NCGM/DIT

Abstract
Malaria elimination during COVID-19 era

Short CV
Dr. Srivicha Krudsood is a senior physician with experience in clinical management ofmalaria including clinical trials. As her expertise, she is also a temporary advisor of World
Health Organization (WHO) in clinical management of malaria, members of many
committees such as country coordinating mechanism (CCM), technical advisory committeeof Thai Ministry of Public Health (MOPH), advisory board of Thai nation antimalarial
committee and also invited lecturer and speaker on clinical tropical medicine and malaria.
Dr. Srivicha has also conducted research in the field of clinical management of malaria, notonly the clinical trials on antimalarial agents but also the clinical aspect including
pathophysiology of malaria. One of the clinical trials which this antimalarial has been
recommended globally is Artemether-Lumefantriene. Two studies (ArtemetherLumefantriene and Tafenoquine) had been audited and approved by the food and drug
administration, United States of America (US FDA). In addition, her practice focuses onclinical management of complicated malaria especially G6PD deficiency.
She is Diplomate of the Thai Board of Internal Medicine
She holds a Master of Science in Clinical Tropical Medicine from Mahidol University after
her graduation from Far Eastern University of the Philippines.
She is well published in peer review journals.

Session 1: 15:45 – 18:40
The New normal for Clinical research (trials)
Chair: Hamana Mieko, NCGM/DIT
Co-chair: Muchanga Sifa, NCGM/DIT

Abstract
Clinical trials for devices and IVD other than COVID-19 device –Malaria

Short CV
Dr. Shigeyuki Kano, honoris causa of Mahidol University, Thailand, is Director of the
Department of Tropical Medicine and Malaria, Research Institute, NCGM, Japan.
He is also serving Professor at various universities including University of Tsukuba, Japan;
Mahidol University, Thailand, and University of the Philippines Manila.
He is contributing to the world malaria elimination program by being appointed Technical
Review Panel Member of the Global Fund or Scientific Advisory Group Member of the NIH
research grant, International Centers of Excellence for Malaria Research.
His main research field is in Lao PDR where he has been conducting genomic
epidemiological studies on drug resistant malaria as Head of the Lao-Japan Parasitology Lab
in the Institut Pasteur du Laos for more than 5 years under JICA project.
He holds a PhD from Gunma University, Japan.
He is member of many academic societies including the Japan Association for International
Health, the Japanese Society of Travel and Health, the Japanese Society of Clinical
Parasitology, American Society of Tropical Medicine and Hygiene, Royal Society ofTropical Medicine and Hygiene etc.
He is well published in peer review journals.

Clinical trials for innovative IVDs for malaria - Do we need to find out more malaria
parasites under COVID-19 pandemic?
Now, the number of infections of the Corona virus has amounted more than 100 million
which is as large as half number of worldwide malaria cases per year. Indeed, the number ofdeaths from the COVID-19 has counted no less than 2.5 million which is coming close to thetotal number of deaths from AIDS, tuberculosis and malaria. While the tropical countries
have made significant improvement in their health system performance, the COVID-19
pandemic presents a huge risk of reversing gains already made in the health sector. In fact,
the COVID-19 pandemic has interrupted program implementation of activities owing to
restrictions on movement and lockdowns. If the current COVID-19 pandemic continues,
interventions for malaria control could be affected severely and the number of the cases anddeaths from malaria will be doubled.
Despite this circumstance, we cannot stop eliminating malaria from the endemic areas,
because malaria is still posing biggest burden to the people in the world. No matter what
disaster may come, we have to find out malaria patients and treat them promptly andproperly. For that, we need new innovative IVDs, namely XN-31, an automatic
flowcytometry-based hematology analyzer to measure the parasite-infected erythrocytes
quantitatively, and PURE-LAMP method for accurate detection of malaria parasite DNA.
We have started clinical trials for the 2 IVDs under the link agreement between NCGM andFaculty of Tropical Medicine, Mahidol University. The reason why we are continuing theapplication of these IVDs to the field condition, even in the COVID-19 era, is to be
discussed.

March 12, 2021

Day 2:March 12, 2021

15:25-15:30
Introductory note
15:30 – 15:50
Keynote speech:
15:50 – 16:20
Session 2
16:20 – 17:55

16:20 – 16:40(08:20 -08:40 Kinshasa)

Opening
Moderator: Hamana Mieko, NCGM/DIT
Regulatory perspectives for the R&D on COVID-19
Mika Togashi, Principal Coordinator, Office of International Programs, PMDA, Japan.
Wataru Sugiura, Director, Center for Clinical Sciences, NCGM
COVID-19 clinical studies- Learning from front-line health workersChair: Muchanga Sifa, NCGM/DIT
Co-chair: Marlinang Siburian, NCGM/DIT
COVID-19 at Kinshasa University Clinics (CUK): Epidemioclinical profile and mortality predictors
Mandina Ndona, Director, Institute for Research in Health Science (IRSS),
Senior Coordinator of the COVID-19 Response at the Kinshasa University Clinics, DRCongo

16:40 –17:00(15:40 -16:00 Manilla)

COVID-19: Perspectives on The Philippine experience
Jubert Benedicto (Chief of Critical Care Units Management Team (CCU-MAT)

17:00 –17:20(15:00 – 15:20 Jakarta)

What is the contribution of Clinical Trials during COVID-19 era: Opportunities and constraints at
hospital site …
Vivi Lisdawati (Director of Research on Infectious and Communicable Diseases, Sulianti Saroso Infectious Disease Hospital, Indonesia)
The experience of clinical research at the NCGM site
Sho Saito (Clinical Investigator, Disease Control and Prevention Center, NCGM)

17:20 –17:40
17:40 –17:47

17:47-17:52
17:52–17:55

Young researcher observations on the management of Covid-19 in Bangladesh
Tania Tabassum (Global Clinical Research Support Group, Department of Medical Innovation, Osaka
University Hospital)
Wrap up
Closing note
Masato Ichikawa, NCGM/DITIntroductory note

Abstract
Short CVMs. TOGASHI Mika is a Principal Coordinator, Office of International Programs, PMDA
in Japan.
She is a pharmacist and holds a master’s degree in Pharmacy.
After working at the Ministry of Health, Labour and Welfare, she joined PMDA and was incharge of QMS (Quality Management System) for medical device and IVD, such as
inspections of manufactures and assessments of certification bodies.
Since April 2019 she has been a member of the current division.

Introductory note:
Regulatory perspectives for the R&D on COVID-19
It is difficult to prepare emerging disease such as COVID-19 in advance. At the first stage of
pandemic, treatment for COVID-19 was not available and medicines approved for otherindications were used as off-label use.
Usually, medicine is developed from non-clinical to clinical in a stepwise manner, and it
takes for several years. However, in such cases early access of the products is required bycitizens, and consequently it is essential to collaborate with regulatory authorities in othercountries.
In addition, since R&D, review and launch for COVID-19 medicines and vaccines isconducted within a short time, it is important to monitor them through product life cycle.
As an approach to what I mentioned above, I will introduce regulatory agility for clinicalstudy under COVID-19 pandemic, Special Approval System and RMP System.

Keynote speech

Abstract
Keynote speech

Short CV
Dr. Wataru Sugiura is the Director of the Center for Clinical Sciences, National Center
for Global Health and Medicine.
He is also serving as Guest Lecturer and Researcher at the Joint Research Center for
Human Retrovirus Infection, Kumamoto University, at the AIDS Research Center, National
Institute of Infectious Diseases
And at the Department of Infectious Diseases and Immunology, Nagoya Medical Center.
Dr Waturu Sugiura has a wide working experience form Public Universities, at the National
Institute of Infectious Diseases (NIID), and private Pharmaceutical companies.
His research focus mainly on AIDS and other Human Retrovirus infections.
He is serving as Editor of the Journal of AIDS Research (official journal of the JapaneseSociety for AIDS Research), Acting Chief Director of Japanese Society for AIDS Research,and Editor of AIDS Patients Care and STDs.
He holds a PhD from Hamamatsu University, Japan
He is well published in peer review journals.

Session 2: 15:45 – 17:55
COVID-19 clinical studies- Learning from front-line health workersChair: Muchanga Sifa, NCGM/DIT
Co-chair: Marlinang Siburian, NCGM/DIT

Abstract
COVID-19 at Kinshasa University Clinics (CUK): Epidemioclinical profile andmortality predictors

Short CV
Dr. Mandina Ndona is Associate Professor at the Department of Internal Medicine at
University of Kinshasa, DRCongo.

The Democratic Republic of Congo declared its first case of COVID-19 on 10 March 2020
in Kinshasa. Several hospitals in the city of Kinshasa have been designated to care forpatients with COVID-19, among them the Kinshasa University Hospital (CUK). The
response to the pandemic has been slow to take hold, gradually strengthened by the supportof traditional partners and the central government. The impact of these interventions has
contributed to an improvement in the management of COVID-19 at the CUK.

She also serves as the Scientific Director at the Institute for Research in Health Science(IRSS), Senior Coordinator of the Covid-19 Response at the Kinshasa University Clinics
and Expert in the National Committee for the elaboration of the COVID-19 treatment
guidelines.

The objectives of this study were to determine the socio-demographic and clinicalcharacteristics of patients with COVID-19, as well as the associated factors and predictors ofmortality.

She holds a Master of Sciences in infectious Diseases and a PhD from University ofKinshasa. She also holds a Post graduate Diploma in Malaria from the University of theMediterranean in France.

This is a consecutive case series of all patients admitted to the unit COVID-19 of CUK from24 MARCH 2020 to 30 JANUARY 2021. A total of 574 patients were admitted to the
CTCO on suspicion of COVID-19 of which 411 were confirmed by a COVID-19 RT-PCR
test COVID-19.
Two waves were observed with a peak in May and December. The average age was 53 years(extremes 4 months and 88 years). Predominantly male 2M/1F, 52.7% had a severe form,
co-morbidities present in 56% (hypertension and diabetes), 91% treated with
Hydroxychloroquine and Azithromycin. Lethality was 34.1%, and predictors of mortality
were age ≥ 60 years, coma, a SaO2 ≤ 95%, the severe form of disease.
Conclusion: Male patient aged 50, hypertensive and/or diabetic was the profile of the
majority of cases. Very high lethality with early hospital mortality.

Session 2: 15:45 – 17:55
COVID-19 clinical studies- Learning from front-line health workersChair: Muchanga Sifa, NCGM/DIT
Co-chair: Marlinang Siburian, NCGM/DIT

Abstract
COVID-19 MANAGEMENT IN THE PHILIPPINES

Short CVDr. Jubert P. Benedicto is a pulmonary critical care specialist primarily connected with the
University of the Philippines-Philippine General Hospital and Lung Center of the Philippines.
He has been an acknowledged clinician and astute researcher and is very well-respected byhis peers and the academic community.
During the COVID-19 pandemic, he has been at the forefront volunteering his expertise
especially in the management of hospitalized critically-ill patients.
As head of the Critical Care Units Management Action Team of PGH, he is very
instrumental in orchestrating the prompt and crucial response of the whole ICU staff that so
far served almost 2,500 patients in the past seven months.
He is also a constant speaker in continuing medical education sessions organized by various
professional groups.
He is also active in various media guesting in the Philippines in order to spread accurate
information on COVID-19 and its management.

University of the Philippines-Philippine General Hospital
COVID-19 has been an elusive pandemic with an enormous and debilitating effect that goesbeyond the health of the afflicted individual. Its effect on the society has been crippling. Its
management principles have been constantly evolving and implementing them at the clinics
and hospital will always need a lot of assistance.
The Philippines is a country made up of over 1,700 islands. Each province has its unique
set of challenges in terms of accessibility and available resources. The national government
has put out policies that attempted to grapple with this pandemic at various fronts and at alllevels. A “whole society approach” is ideal yet very challenging.
A pragmatic framework anchored on science is being tried and adjusted based on contextual
realities.

This short session will attempt to provide participants a unique glimpse of the Philippine
COVID-19 landscape and its specific set of management dilemmas and potential solutions.

Session 2: 15:45 – 17:55
COVID-19 clinical studies- Learning from front-line health workersChair: Muchanga Sifa, NCGM/DIT
Co-chair: Marlinang Siburian, NCGM/DIT

Abstract
What is the contribution of Clinical Trials during COVID-19 era: Opportunities andconstraints at hospital site …

Short CVDr Vivi Lisdawati is the Director of Human Resources, Education and Operational at
Sulianti Saroso Infectious Disease Hospital.
Responsible for facilitating the need of research management at Sulianti Saroso IDH since2016, including clinical trial on Covid-19 since 2020.
Prior to her current position, She has served as Leads national research on vector borne
diseases and national facilities based survey on Privat Clinical Laboratory group.
She was also Research Coordinator for TB group on Indonesian Health National Survey andPrincipal Investigator on developing molecular diagnostic for rapid detection of Lung TB
using specific primers designed based on epidemiology data.
She got national patent as Inventor of the specific primer for LAMP method.

She has been graduated from the Faculty of Pharmacy, University of Indonesia as
Pharmacist and Master Degree in Natural Herbal Science Program.
She received the PhD from Faculty of Medicine, University of Indonesia on Biomedical
Science Program.
She has been member of many National Organizations including the Material Transfer
Agreement committee, The National Biobank Committee, National Consortium on Vaccines
Research, etc.

During the pandemic of Covid-19, given the new type of Coronavirus (SARS-CoV-2), there
was a dilemma about dealing with this situation. Regarding global data in early January
2021 with a total positive case of more than 100 million people and the cure rate around 64
million, clinical trials of management Covid-19 have become a global priority. On the one
hand, the protection of health workers must be considered, the strict implementation ofhealth protocols while considering ethics and quality of research is something that must be
considered in conducting research.
With more than 1.3 million positive cases and more than 35,000 deaths, the implementationof the clinical trial in Indonesia is part of the main solution to overcoming the Covid-19
problem. Sulianti Saroso Hospital as a referral hospital for infectious diseases in Indonesia
has more than 1,100 inpatients who are confirmed positive for Covid-19 by the end ofJanuary 2021, with clinical symptoms categories are moderate (72%), severe (15%) andcritical (9%).
Several multicenter studies have taken place, including the International Randomized Trial
for Additional Care for Covid-19 (WHO Solidarity Trial). The preliminary results have been
published in the New England Journal and had been used as an update of WHO’s guidelineon the clinical management of Covid-19 patients and have also been used at Sulianti Saroso
Hospital as part of SOC for patients.
Regarding that the results of clinical trial that are very useful for improving the managementof Covid-19 in patients, a number of studies are still being conducted to date, including
Convalescent Plasma Transfusion Therapy and the Application of Mesenchymal Stem Cells.
Therefore, the opportunities for proper clinical management of Covid-19 is likely to beobtained.

Session 2: 15:45 – 17:55
COVID-19 clinical studies- Learning from front-line health workersChair: Muchanga Sifa, NCGM/DIT
Co-chair: Marlinang Siburian, NCGM/DIT

Abstract
The experience of clinical research at the NCGM site

Short CV
Dr. Sho Saito is Clinical Researcher and Physician at the Disease Control and Prevention
Center, National Center for Global Health and Medicine, Japan
Prior to his current position, He has been a Researcher and fellow at the Shizuoka Cancer
Center and at the Department of Infectious Diseases, University of Yamanashi, respectively.
DR Saito is certified Infectious Diseases Doctor and Pediatrician.
He is member of the Japanese Association for Infectious Diseases and the Japan PediatricSociety.

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was first reported in China
in December 2019, and Japan confirmed its first case of coronavirus disease (COVID-19) in
January 2020. In the global pandemic of COVID-19, we have conducted many researches at
NCGM and through global collaboration to elucidate the actual status of COVID-19.
We participated in a global clinical trial in collaboration with the US NIH in February 2020,
which demonstrated the efficacy of the antiviral drug remdesivir. The research collaboration
with the NIH has been continued. We conducted the second trial with the NIH and clarified
the efficacy of the immunosuppressive agent baricitinib. As of January 2021, a randomized
controlled trial to compare the efficacy of baricitinib to dexamethasone is underway. We arealso participating in a global clinical trial to clarify the efficacy of immunoglobulin.
In March 2020, we established a large-scale COVID-19 registry (COVIREGI-JP), and as ofJanuary 2021, we have collected detailed clinical information on 24,017 cases at 872 sites inJapan. Characteristics of patients in the country have been clarified, and more information
has been gathered through further researches using the registry. Research on COVID-19
sequelae has also progressed, revealing that 27% of patients still have some sequelae fourmonths after onset.
We began collecting plasma from patients who had recovered from COVID-19 in May
2020 and plan a randomized control trial (COVIPLA-RCT) to determine the efficacy in
February 2021. We will continue to contribute to the global effort to counter COVID-19
through diligently pursuing research.

Session 2: 15:45 – 17:55
COVID-19 clinical studies- Learning from front-line health workersChair: Muchanga Sifa, NCGM/DIT
Co-chair: Marlinang Siburian, NCGM/DIT

Abstract
Young researcher observations on the management of Covid-19 in Bangladesh

Short CV
Dr. Nisa Tania Tabassum is Master student at the Global and Innovative Medicine, Osaka
University
She has been supporting research as Specially appointed researcher at Osaka University.
Her current research focuses on Health risk factors assessment for both non-communicablediseases and communicable diseases among university students in Japan and ASEAN
Prior to joining her current position, She has been a Medical Interpreter.
She holds a Bachelor in dental Surgery from Sylhet M.A.G Osmani Medical College of
Bangladesh.

The novel coronavirus (SARS-CoV-2) is holding the headlines worldwide since early 2020
due to its unprecedented speed of transmission and case fatality ratio.
Whilst many developed nations faced impulsive health-system downfall, Bangladesh, amedium income country with overburdened population and fragile medicare infrastructure,
tried its farthest to combat the pandemic. Infections remained low until the end of Marchfollowed by an accelerated upward trend up to mid-December in 2020.
In the interim, government has executed miscellaneous strategies indexing from COVID-19
classic preventive approaches to nationwide lockdown, educational institution closure,teleworking, foreigner entry bans etc.
Occasional controversies and rumors were not uncommon all-round the period pointing
mismanagement, economic loss, insufficient PCR testing, corruption in the healthcare
system and frequent death of COVID-19 front liner doctors.
Confronting all those allegations, Bangladesh kept the COVID-19 new case and death tally
curve earthward since December 2020 and started Covid-19 nationwide vaccination drive
aiming to inoculate 3.5 million people in February 2021.
Regionalization of the healthcare system, combining exhaustive and integrated measures is
helping Bangladesh to scrap COVID-19 in a less restricted and non-shutdown situation, withsustaining the economy of the country.

CLOSING NOTE