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Many of the Initial COVID-19 Treatment Trials Poorly Designed

One-third of trials do not include clinical end points; 97 randomized trials were open-label design

FRIDAY, June 12, 2020 (HealthDay News) — Many clinical trials for COVID-19 treatments are limited by their design, with one-third excluding clinical end points, according to research published online June 9 in BMJ Open.

Hemalkumar B. Mehta, Ph.D., from the Johns Hopkins University Bloomberg School of Public Health in Baltimore, and colleagues conducted a cross-sectional analysis of 201 clinical trials for COVID-19 treatment, which examined the therapeutic benefits of 92 drugs or plasma.

The researchers found that eight products or combinations involved new molecular entities. A wide range of prior medical uses was seen for other test therapies, including antivirals, antimalarials, immunosuppressants, and oncology treatments. Patients were randomly assigned to treatment or a comparator in 152 trials, including 55 with some form of blinding and 97 open-label trials. Twenty-nine of the trials without a randomized design were single-armed studies, and 20 trials had some comparison group. Multiple end points were featured in most trials. Two-thirds of the trials (66.7 percent) identified clinical end points, such as COVID-19 symptoms, death, recovery, required intensive care, and hospital discharge. In 16.4 percent of trials, clinical scales were used, most often measures of oxygenation and critical illness. In 42.3 percent of trials, surrogate end points or biomarkers were studied, mainly assays of viral load. From March 1 to 26, 2020, the number of registered trials doubled.

“We understand the urgency of clinical research on COVID-19, but this is a time when we need rigorous science to inform policy and clinical decision-making,” a coauthor said in a statement.

One author disclosed financial ties to the health care and health technology industries.

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