Majority of First-Wave COVID-19 Trials Have Significant Design Shortcomings - COVID-19 Clinical Trial
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Majority of First-Wave COVID-19 Trials Have Significant Design Shortcomings

The majority of trials in the U.S. clinical trials registry were registered from international researchers. Among the 201 trials analyzed, 126 were recruiting participants from China, 31 from Europe, 14 from the U.S.The researchers found that many of the trials lacked key features needed to optimize their scientific value such as the use of control groups and patient and clinician blinding.The analysis found that one-third of trials lacked clinical endpoints to clearly define success or failure. Nearly one-half were designed to enroll fewer than 100 patients, limiting their usefulness to assess modestly-sized treatment benefits.

Two-thirds were “open label,” meaning that patients and doctors were aware who did and didn’t receive the treatment — in principle, allowing their unconscious expectations to influence the results.”Because of these weaknesses, many of these studies are likely to yield only preliminary evidence,” says study first author Hemalkumar Mehta, PhD, an assistant professor in the Department of Epidemiology at the Bloomberg School. “Given the urgency of identifying definitive evidence on potential COVID-19 treatments, this is an instance where we wish we did not have to say ‘further research is needed’ because of basic trial design shortcomings and small trials.”


Statin Use is Linked to Lower Death Rate in Hospitalized COVID-19 Patients

The use of cholesterol-lowering drugs called statins is associated with a lower death rate and a lower incidence of mechanical ventilation in patients hospitalized with Coronavirus disease 2019 (COVID-19), researchers report June 24 in Cell Metabolism. The large-scale retrospective study also showed that mortality risk and other negative outcomes were not increased by combination therapy consisting of statins and blood pressure-lowering drugs called angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs).

“These results support the safety and potential benefits of statin therapy in hospitalized patients with COVID-19 and provide a rationale for prospective studies to determine whether statins confer protection against COVID-19-associated mortality,” says senior study author Hongliang Li of Wuhan University.

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