COVID-19 clinical trials: From concept to results

Published: 15 Aug 2020

The “COVID-19: Updates from Singapore” weekly webinar series is a forum for leading clinicians, scientists, public health officials and policy makers to share insights from their fields of study. The 19th webinar session was held on Thursday, 13 August at 7pm.

The invited guest speaker for this week was Professor Peter Horby, Professor of Emerging Infectious Diseases and Global Health at the University of Oxford. He is also the founding Director of the Oxford University Clinical Research Unit in Hanoi, Vietnam, which conducts research on infectious diseases that crosses the disciplines of basic science, medical science and public health. A globally well-respected clinician and investigator, he shares his experience in conceptualising, implementing and completing large randomised controlled trials around the world.

Titled COVID-19 Clinical Trials: From Concept to Results, Prof Horby started the webinar by introducing the International Severe Acute Respiratory and Emerging Infection Consortium, which was first formed in 2009 after the less-than-satisfactory efforts to run clinical trials during the 2009 Influenza pandemic. Prof Horby described this situation as an epidemic curve of ambition, where there were lots of bright ideas, a few protocols, small patient sample size and zero evidence. Since 2009, there have been efforts to encourage the progression of clinical trials such as those related to the  2014-2016 West Africa Ebola outbreak. Then, the usual time period of 20 months for a grant to be awarded to enrolling the first patient, was reduced to 3.5 months. Though the trials did not get far in improving the care of Ebola because of the late start, the ability to run clinical trials improved tremendously. Another improvement seen was during the 2018-2020 Eastern DRC Ebola outbreak where a trial started quite early. This time, definitive conclusions were achieved that altered the way clinical trials were conducted . Prof Horby cautioned that the clinical trial timeline used during the Ebola outbreak over two years is encouraging. It is still a question of whether this trial timeline is applicable to most short-lived epidemics of 6 to 8 weeks.

With regard to COVID-19, Prof Horby mentioned that clinical trials started very early in Wuhan but because of the strict lockdowns there, the patient numbers diminished very quickly and became insufficient to reach definitive conclusions. With that, clinical trial efforts were shifted to the United Kingdom where COVID-19 cases were climbing, and this was where the Randomised Evaluation of COVID-19 Therapy trial programme started. Prof Horby highlighted that the running of clinical trials had to be operable in midst of an overstretched health service and huge pressures of frontline medical staff, as well as huge therapeutic uncertainty that the UK was facing. Eventually, it was agreed that the clinical trial must be quick, with simple procedures for patient recruitment, and large, to gather modest benefits that could result in big improvements in assessing patient mortality during a pandemic. The COVID-19 clinical trials were held early in the UK which allowed them to capture the big peaks, together with the participation of more than 175 hospitals who enrolled patients into the trial. Prof Horby went through the treatments used such as Lopinavir-ritonavir, Hydroxychloroquine and treatments for the immunological inflammatory process such as Dexamethasone and Tocilizumab, and summarised the results observed from each drug used.

In conclusion, Prof Horby and his team are currently looking to prolong the duration of this clinical trial over winter by exploring the inclusion of another anti-viral, anti-spike antibody and possibly anti-coagulant in the clinical trial.

WATCH: COVID-19 Updates from Singapore: Webinar 19 | Prof Peter Horby