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Cytel expands unique trial for early COVID-19 treatments in Global South

Two South Africa sites added to TOGETHER platform trials for the outpatient treatment of high-risk adults infected with SARS-CoV-2

Pictured: Dr Edward Mills, VP of Strategic Consulting and Principal Scientist at Cytel, Principal Investigator of the TOGETHER trial.

Pictured: Radek Wakias, Chief Data Officer at Cytel.

Cytel Inc. has significantly widened the geographical scope of the TOGETHER trial, a unique study to identify early COVID-19 interventions in underserved low- and middle-income country (LMIC) populations. The trial, supported with seed funding from the Bill & Melinda Gates Foundation, is one of the very few studies investigating therapies at the earliest stages of COVID-19 infection, and is the only trial to explore early interventions in the Global South. The expansion consists of two new sites in South Africa to complement the study sites actively recruiting in Brazil and the United States. By leveraging its expertise in such complex trial designs, Cytel’s Global Health team is making a lasting contribution to local trial infrastructure to support future clinical investigation in these vulnerable populations.

With many hospitals in LMICs critically under-resourced, there is deep concern around their ability to withstand the impact of increasing COVID-19 cases. Further, most COVID-19 clinical trials are currently operating in wealthy countries in already hospitalized patients, where study populations do not reflect the characteristics of those in poorer nations who are not yet hospitalized. In addition, many of these trials exclude marginalized groups such as those living with HIV and people with active or latent tuberculosis, who are key populations of interest for LMICs. As such, there is an urgent need to commence clinical investigation within these underserved LMIC populations, identifying repurposed therapies that halt disease progression to effectively reduce hospital burden.

“By using an adaptive platform trial design for TOGETHER, we’re boosting our ability to rapidly identify those key therapies that can reduce chances of hospitalization from COVID-19 – a vital approach for areas around the globe that simply cannot cope with greater hospital demand,” commented Dr Edward Mills, VP of Strategic Consulting and Principal Scientist at Cytel, who is leading the TOGETHER trial. “But implementing such a trial is no easy task. A much deeper level of statistical insight needs to feed into the design and analysis stages, and operational complexities are an order of magnitude greater than in traditional randomized controlled trials. Understanding and navigating these efficiently has been crucial for tapping into the full potential of platform trials to help with COVID-19.”

Platform trials are of increasing interest to pharmaceutical companies owing to their ability to significantly cut costs and boost development efficiency. Through seamless additions of new and promising interventions, the ability to drop poorly performing therapeutics, and the use of shared control groups, platform trials enable smaller study populations and can be quicker to reach meaningful conclusions.

The TOGETHER trial is being led by Dr Edward Mills along with researchers at the University of Washington and will concurrently evaluate several repurposed treatments for early-stage COVID-19 in those at high risk of disease progression. The adaptive framework of the trial also allows for inclusion of additional study arms to evaluate newly emerging early COVID-19 treatment candidates.

“LMICs are particularly susceptible to COVID-19 devastation, and the higher prevalence of conditions associated with COVID-19 complications in their populations is especially worrying. We need to aggressively pursue clinical strategies that optimize their ability to cope,” said Radek Wasiak, Chief Data Officer at Cytel. “Conducting trials tailored to the population characteristics of LMICs is a key step in the broader, unified fight against COVID-19 – and Cytel is one of the handful of organizations spearheading this effort. By implementing and expanding the TOGETHER trial, Cytel is also investing in lasting trial infrastructure in regions of the globe that have the most to lose from pandemics such as this one.”