Accelerating clinical evaluation of repurposed combination therapies for COVID-19

As the COVID-19 pandemic continues, clinical trials have demonstrated limited effective pharmaceutical interventions and have shown the need for accelerated treatment evaluations. One option is evaluating drug combinations without prior monotherapy data. This offers a couple of benefits, including addressing different pathways of the disease, and detecting if one part of the combination is effective. Additionally it saves time and increases the likelihood of finding a treatment. The election of the antiviral combination can be guided through insights about the SARS-CoV-2 pathophysiology and cell cycle dynamics. We describe a clinical evaluation strategy using adaptive combination platform trials to rapidly test combination therapies to treat COVID-19.
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Abstract

As the global COVID-19 pandemic continues, unabated and clinical trials demonstrate limited effective pharmaceutical interventions, there is a pressing need to accelerate treatment evaluations. Among options for accelerated development is the evaluation of drug combinations in the absence of prior monotherapy data. This approach is appealing for a number of reasons. First, combining two or more drugs with related or complementary therapeutic effects permits a multipronged approach addressing the variable pathways of the disease. Second, if an individual component of a combination offers a therapeutic effect, then in the absence of antagonism, a trial of combination therapy should still detect individual efficacy. Third, this strategy is time saving. Rather than taking a stepwise approach to evaluating monotherapies, this strategy begins with testing all relevant therapeutic options. Finally, given the severity of the current pandemic and the absence of treatment options, the likelihood of detecting a treatment effect with combination therapy maintains scientific enthusiasm for evaluating repurposed treatments. Antiviral combination selection can be facilitated by insights regarding SARS-CoV-2 pathophysiology and cell cycle dynamics, supported by infectious disease and clinical pharmacology expert advice. We describe a clinical evaluation strategy using adaptive combination platform trials to rapidly test combination therapies to treat COVID-19.

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