CHAPTER 8: COVID-19 Interventional and Therapeutic Clinical Trials: Small Molecules, Interactions, Outcomes and Opportunities

The coronavirus disease 2019 (COVID-19) pandemic has created tremendous urgency to move treatments through clinical trials. Trial sponsors are trying many strategies (e.g. flexible designs, repurposing). In a short period of time an unprecedented number of treatments will be tested in trials against a single viral disease. This chapter covers the different types of small-molecule interventional clinical trials, their relevant subpopulations (e.g. infected, critically ill), potential therapeutics and their modes of action, expected outcomes, toxicities, and future opportunities. This chapter explores the opportunity for more standardized outcomes and outcome reporting (e.g. report cards) for easier comparisons. Given the certainty of other pandemics in future, we should consider taking the successful designs and collaborations from the COVID-19 clinical trials experience and developing them into protocols ready to be put in place immediately for the next pandemic. The current crisis is also an opportunity to examine the limitations of the current clinical trials system with respect to the general lack of systematic investigation of treatment resistance in interventional clinical trials, which led to fatal outcomes. The clinical trial system can only truly be an iterative process if we start answering the question “was it the target or the therapy?” when targeted therapies are ineffective.