According to Clinical Ink, its specialists built and deployed an electronic study environment for cytokine storm in 15 business days. The effort included creating the study’s full assessment schedule, edit checks and logic, and complete user-acceptance testing.
Jonathan Andrus, Clinical Ink’s chief business officer, told Outsourcing-Pharma that the contract research organization tackling the study approached the company because of its eSource and direct data capture (DDC) capabilities. The team decided to use Clinical Ink’s Lumenis platform to ramp up the study.
“The speed with which we could get the study built, coupled with the ability for both the CRO and the sponsor to have immediate access to their data, was critical in the decision to move forward with us for this vital study,” Andrus said.
Andrus explained a typical build schedule for a study like this cytokine storm effort could stretch over 12 or more weeks, considering the number of specialized edits, logic and other complex aspects. However, he told us, the team was able to accelerate the timeline with a number of innovative moves, including conducting edit checks throughout the entire study design.
“These real-time edits and logic reduce the number of manual queries as compared to how many would have to be resolved in a traditional study,” he said. “Not only did the CRO and sponsor save weeks on the front end, but they will also save many weeks when it comes to database lock; this is because many, if not all, of the data issues will already have been addressed at the time of data collection.”
Patients with severe cases of COVID-19 have been reported to suffer with a number of insidious complications, and cytokine storm is among the trickiest. It is, as Andrus explained, a severe immune reaction in which the body releases too many cytokines, a variety of proteins that effect reactions between cells, into the blood too quickly.
Cytokines are crucial in normal immune response function, but when a large amount is released in the body all at once, it can have detrimental effects, including an increased risk of vascular hyperpermeability, multiorgan failure, and mortality. A cytokine storm occurs in a number of situations, typically because of an infection, autoimmune condition, or other disease like COVID-19.
The drug at the center of this research is a novel intravenous anti-inflammatory. This new molecular entity is a granulocyte macrophage colony stimulating factor antagonist that already has Phase I safety data from a clinical trial in volunteers and patients with ankylosing spondylitis.