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, PhD, 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 8 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%) identified clinical end points, such as COVID-19 symptoms, death, recovery, required intensive care, and hospital discharge. In 16.4% of trials, clinical scales were used, most often measures of oxygenation and critical illness. In 42.3% 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.

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“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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