Researchers at Johns Hopkins University have opted to use Prelude Dynamics’ VISION electronic data capture (EDC) solution on three COVID-19-related studies.
Tommy Jackson, Prelude Dynamics COO, told Outsourcing-Pharma that VISION EDC appealed to the researchers because of its advanced capabilities, ability to accelerate study startup, flexibility and other features.
“We differentiate ourselves from other software vendors both through the flexibility of the software and our deep level of service. Every clinical trial is unique, by design, and that fact has been built in and embraced as a configuration-based mature s/w system,” he said.
The virus-related study partnership comes after previous collaborations between Prelude Dynamics and the research university on a variety of other studies. Since they first collaborated on a brain hematoma study more than 10 years ago, they’ve worked together on studies focused on multiple sclerosis, brain hematomas, Alzheimer’s dementia, and more.
“The relationship progressed from that initial study because they were impressed by our software’s ability to handle the complexities and adaptive nature of what Hopkins researchers were trying to accomplish,” Jackson said.
One of VISION EDC’s features is its ‘just in time’ randomization framework. Each random treatment is generated at the moment a subject is randomized, rather than reading from a precomputed table of treatments, as is the case with similar technologies.
“Unlike pre-generated tables, just-in-time assignments cannot be accidentally exposed in advance, thereby eliminating selection bias and ensuring masking. The randomization framework handles any block size, treatment names, and ratios, as well any number of stratification factors, specified as database elements and as site or study wide,” Jackson explained
Plasma donor registry
This study centers on a registry of individuals who have recovered from COVID-19 and are candidates for plasma collection. Once donors are qualified, their human coronavirus immune plasma (HCIP) can be used in the second and third studies; these follow-up studies are both Phase 2 and will be randomized and double-blinded.
Convalescent plasma as preventative
The second study will investigate the use of convalescent plasma in high-risk subjects who have experienced a close contact exposure to a person with COVID-19 but are not yet symptomatic. With an enrollment goal of 150 subjects, the project will study the efficacy and safety of using HCIP as a preventative treatment.
Convalescent plasma to reduce complication
The third study will investigate the use of HCIP as a therapy for ambulatory subjects who have tested positive for COVID-19 through an RNA detection test and have at least one symptom. With an enrollment goal of 1,344 subjects, this project will study the efficacy and safety of using HCIP to reduce complications due to COVID-19.
In addition to saving lives, a positive outcome for this trial, according to the company, will mean HCIP has the potential to greatly reduce hospitalization and ICU requirements for COVID-19 patients.