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

Many of the Initial COVID-19 Treatment Trials Poorly Designed

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.

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