A two-country clinical trial that involves a nasopharyngeal swab and two assays sounds relatively straightforward. But when you’re conducting a study during a global pandemic and Brexit, nothing is simple. A combination of creative logistics, careful planning, and a strong customer relationship allowed Cerba Research to keep sample processing for a novel COVID-19 treatment on track in the middle of extraordinary upheaval.
A randomized, controlled Phase IIb clinical trial to evaluate the safety and efficacy of the sponsor’s drug for high-risk subjects with mild COVID-19. The subject population enrolled a total of 600 men and women aged 18 years and over, recruited in the U.S. and the U.K., and initially included 25 U.S. sites and 10 U.K. sites. However, as COVID-19 continued to impact investigator and site availability and patients’ willingness to visit sites, the sponsor moved to a decentralized model.
Once the sponsor randomized patients into the trial, a “COVID in a Box” kit was delivered to patients’ homes. Patients could then decide whether to participate on-site or remotely using telemedicine. Most chose the latter.
Once the patient supplied the sample and repacked the box, an agent from Marken, the preferred courier, arrived within the hour to collect the sample. Both agent and patient followed a strict process using physical distancing and personal protective equipment (PPE) during the handoff.
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Case Study – How Cerba Research helped advance a Phase 1B study in the middle of a pandemic and Brexit
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