COVID-19
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Introduction
Berry designed many of the most impactful clinical trials in the world for COVID-19, in combination with partners from every continent on earth except Antarctica. The majority of these trials were adaptive platforms, a design pioneered by our founder Dr. Don Berry within oncology and now used in indications across the spectrum of medicine. Adaptive platform trials investigate multiple therapies simultaneously, achieving tremendous efficiency (gains of 30-50% over standard clinical trial designs) through sharing control patients across arms, adaptive stopping of arms for efficacy or futility, and reinvestment of saved resources into new arms. The COVID-19 platforms also included the novel features of multiple domains of investigations, allowing combinations of treatments to be explored. These large trials investigated many dozens of potential therapies for COVID-19 and had significant impact on clinical care of patients worldwide throughout the pandemic.
In addition to trial design, Berry statisticians also participated in the COVID-19 predictive modeling efforts in Los Angeles County (population 10 million), a group effort which resulted in a gold medal (1st place) prize at the 34th Annual Quality and Productivity Award for LA County.
Berry Examples and Case Studies
REMAP-CAP was inspired by efforts to combat the Ebola epidemic in West Africa in the 2010s. Large, complex trials take time to develop, time that may not be available in a rapidly emerging epidemic or pandemic. Based on the experience of developing Ebola trials, REMAP-CAP was designed to investigate community acquired pneumonia, but contained a “sleeping protocol” prespecified to address a pandemic. In 2020, at the start of the COVID-19 pandemic, this sleeping protocol was pulled off the shelf and REMAP-CAP started to enroll patients on March 9, 2020. REMAP-CAP is a domain-based platform trial, exploring treatment combinations in addition to single arms. As of writing, REMAP-CAP has enrolled 18,582 COVID-19 patients and explored 66 different interventions across 18 domains.
PRINCIPLE was a UK (Oxford) based platform trial investigating multiple therapies for COVID-19. PRINCIPLE investigated Hydroxychloroquine, Inhaled budesonide, Azithromycin, Doxycycline, Colchicine, Ivermectin, and Favipirivir. It enrolled 11,768 across 847 recruitment sites
PANORAMIC, also based in the UK (Oxford) is the largest community based COVID-19 trial ever, having enrolled 29295 participants.
The teams behind PRINCIPLE and PANORAMIC were awarded the prestigious Prix Galienaward (Best Public Sector Innovation) in June of 2024.
ANTICOV was the largest COVID-19 platform trial in Africa, exploring multiple early treatment options within low resource settings. ANTICOV enrolled 1753 patients across 29 sites in 12 countries.
