Webinar Series on Demystifying Phases in Clinical Trials & COVID-19 Updates organized by Institute for Clinical Research (ICR), NIH Speaker: Dr Chow Ting Soo, Consultant Infectious Disease Physician, Penang General Hospital, Malaysia. More information, please visit: https://clinupcovid.mailerpage.com/resources/w5b4h7-palliative-care-in-covid-19-malay

1. •Challenges & Successes
•Malaysia Experience
•NMRR-20-686-54503
SOLIDARITY TRIAL
Dr Chow Ting Soo

2. Disclaimer
•This slide was prepared for the Webinar Series Demystifying
Clinical Trials & COVID-19 Updates session on 21st July 2021,
by Dr Chow Ting Soo, Consultant Infectious Disease Physician,
Penang General Hospital, Malaysia.
•This is intended to share within healthcare professionals, not for
public.
•Kindly acknowledge “Clinical Updates in COVID-19
http://www.nih.gov.my/covid-19” should you plan to share the
information obtained from this slide with your colleagues.

3. Introduction
Solidarity is an international clinical trial
To identify effective treatment for COVID-19
Launched by the World Health Organization and
partners
Largest international randomized trials for COVID-19
treatments, enrolling almost 12 000 patients in 500
hospital sites in over 30 countries.

4. What is Solidarity Trial?
Multi centre , Open label , Randomised
• HCQ
• IFN
• LPV/r
• Remdesivir
Evaluating the effect of drugs vs SOC:
• mortality,
• need for assisted ventilation and
• duration of hospital stay.
On 3 important outcomes in COVID-19 patients:

5. Why does it work?
Simplified trial procedures
Once approval is obtained (regulatory and ethical),
electronic entry of patients who have given informed
consent
Online randomization of consented patients (via a
cloud-based GCP-compliant clinical data management
system).

6. Very special design :
•Simple inclusion criteria
•Confirmed COVID-19, hospitalized and consented
•age ≥18 years, not known to have received any
study drug, without anticipated transfer elsewhere
within 72 hours, and, in their physician’s view, with
no contra-indication to any study drug.
•All severity
•Except those critically ill (not able to survive in next
48 – 72H)
•SOC : local guidelines

7. Unique clinical trial
•The Solidarity Trial is an adaptive trial.
•This means that some unpromising drugs
have been dropped and others will be added.
•Hydroxychloroquine and lopinavir/ritonavir
arms were discontinued on 20 June and 4 July
2020 respectively.
•Interferon was dropped a month later
•Remdesivir vs SOC

8. Success
•Streamlined trial initiation due to public
emergency
•Fastest ethics clearance by MREC (clearance
given within five days, approved by a Full Board)
•Fast-tracked CTIL clearance by NPRA (clearance
given within seven days, evaluated by 8 reviewers
from NPRA)
•Study grant of RM81,000 was allocated for this
study
•Efficient IMP distribution to site (achieved within
four days, facilitated by Ampang CRC)

9. Trial timeline
Project Activity Start End Status
1 MREC approval 06/04/2020 10/04/2020 Achieved
2 NPRA approval 10/04/2020 17/04/2020 Achieved
3 IMP distribution to Sites 4/5/2020 8/5/2020 Achieved

10. Success
•Great support from major hospitals
•Nine major hospitals
•MOH representative Datuk Dr Suresh Kumar+ 9 Principal
investigators +
•62 co-investigators
•Facilitated by researchers Institute of Clinical Research
•Total recruitment: 217 patients
•63 remdesivir, 30 HCQ, 47 lopinavir/ritonavir, 5 interferon,
72 SOC

11. Team member
HSB
DR Yasmin Gani
Dr Tuang Wei Xuan
Dr Vijayendran Rajalingam
Dr Aruna Karthigayan
Dr Sujana Leon Sean
Saravanamuttu
Dr Suvintheran Thangavelu
Dr Syarifah Nurul Ain bt Syed
Badaruddin
Dr Swarna Lata Krishnabahawan
Puan Rozila binti Harun
Puan Hannah binti Md Mahir
Dr Tharmini A/P Ravi
Hospital KL
DR Leong Chee Loon
Dr Khairil Erwan Khalid
Dr Rasidah bt Senian
Dr Syed Sharif Anwar Aljafri
Dr Suraya Hanim Abdullah Hashim
Dr Shaharudeen bin Kamaludeen
Dr Karina Koh
Dr Lee Jen Ven
Mohamad Ikram Zaki bin Jaafar
Mak Woh Yon
Sim Poh Pei
Dr Nik Nur Eliza binti Mohamed

12. Team member
Hosp Melaka
DR Nor Zaila
Dr Shalini Vijayasingham
Dr Tay Qin Le
Dr Karamjit Kaur a/p Sarban Singh
Dr Norlizam bin Mohd Nor @ Mat Nor
Delarina Frimawati binti Othman Andu
Dr Siti Hir Md Tahir
Tay Eek Poei
Seri Rabiatul Nur Binti Abu Salim
Hospital Pulau Pinang
DR Chow TS
Dr Wee Hong Chin
Dr Kelvin Beh
Ms Ng Ru Shing
Ms Lim Yen Li
Mr Mak Wen Yao
Dr Wong Peng Shyan
Dr Leong Kar Nim
Dr Kang Kong Yeow
Dr Lee Kok Soon
Dr Carmen Koay Gaik Bee
Mr Chong Meng Fei
Mr Wong Kar Loon

13. HSBAS
Dr Low Lee
Lee
Dr Mohd Azri Mohd Suan
Dr Nadiah Hanim Zainul
Dr Ho Yi Bin
Dr Yeoh Chian Hui
Dr Hidayatil Alimi B Keya Nordin
Wong E-Jinq
Noor Syahireen Mohammed
Hospital Umum
Sarawak
Dr Chua HH
Dr Tong Xun Ting
Dr Andrew Chang Kean Wei
Dr Lim Han Hua
Dr Tonnii Sia Loong Loong
Dr Chew Lee Ping
Dr Yeo Leh Siang
Mdm Ngua Ching Zin
King Teck Long
Aylwin Lim Ming Wee
Shirin Tan Hui
Shirley Tan Siang Ning
Tiong Lee Len
Hosp Tuanku
Fauziah
Dr Suhaila
Dr Shafarul Halimi Mohamed
Dr Noor Hafini Abdul Sukur
Dr Wong Chee Kong
Dr Azri Nordin
Ms Alia Hayati Baharudin
Ang Wei Chern
Dr Amalina Anuar
Mdm Siti Ertina Asli
Dr John Yeo
Dr Chuah Seow Lin
Dr Benjamin Sachdev
Dr Vanusha
Dr Ng Chun Sien
Dr Abirami
Dr Nur Shairah Fatin
Dr Andy Ko
Dr Tay Kim Siang

14. HTAF
Dr Dzawanie
Dr Janattul Ain bt Jamal
Lim Bee Chiu
Dr Noorlina Binti Nordin
Dr Tan Sin Nee
Dr Evelyn Aun Su-yin
Dr Chiew Ken Seng
Dr Ng Kwang How
Dr Roenita bt. Baharudin
Dr Fariz Safhan Bin Mohamad
Nor
Dr Muhammad Zihni Abdullah
Dr Kiren Kaur
Che Wan Mohd Hafidz bin
Che Wan Ahmad
HQE
Dr Lee Heng Gee
Dr Nagarajan a/l Nagalingam
Dr Fong Kean Khang
Dr Khoo Thien Meng
Dr Jason Kong Henn Leong
Dr Saw Yen Tsen
Dr Lim Ming Yao
Mdm Juhanah Gimbo
Ms Teong Win Zee
Ms Norhaziah Mohamad
Salleh
Dr Wong Yiko
Dr Tan Yee Ann

15. Final results published in New England Journal of
Medicine Link: https://www.nejm.org/doi/full/10.1056/NEJMoa2023184

16. Innovations
•First study to allow virtual consent taking
•In real-time due to the infectious nature
of COVID-19
•Minimize exposure of investigators
•Without compromising GCP principles
•One of the largest trials on COVID-19
•Over 11k sample size globally
•Adaptive trial
•Fast-tracked trial approval mechanism
(record time)

17. Innovations
•All nations involved had regular meeting, initially
weekly, biweekly, and then monthly
•Zoom platform | Every Wednesday 9.30 pm
Malaysia time
•Discussed: issues, re-distribution of IP, ECRF
and sharing difficulties and success
•Monitoring: done by pharmacist and ICR monitor,
experienced and very stringent monitoring.

18. Innovations
● web based CRF and randomisation
● EDC castor
● required simple data
● eligibility
● consent upload
● choose IP that is available
● simple medical history
● classification of severity of disease
● randomised
● treatment outcome

19. Challenges
•Shipment of IMP to Malaysia was delayed due
to unforeseen circumstances
•Temperature excursion (interferon & HCQ)
•The batch was quarantined and not used
•Caused further delays in patient enrolment
•Trial administration challenges
•Time-zone difference with WHO Geneva
(scheduling difficulties)
•Coordinate large scale trial under MCO

20. Challenges
•Recruitment of cases:
•Busy settings
•Uploading consent – tech savvy
•Investigators concern : SOC vs IP
•Overcome :
•Regular discussion in team
•Sharing experience

21. What is the next step?
•Solidarity Plus
•Awaiting approval…
•More countries will be involved

22. HOPE
•Antiviral
•Anti inflammatory
•Monoclonal antibodies