Analysis of the clinical development landscape targeting long-COVID and evolution of clinical outcome assessment methods – An industry perspective

Long-COVID is the term used for health complications seen in patients recovered from acute coronavirus disease-19 (acute COVID-19) illness. The spectrum of clinical symptoms, involvement of various organ systems, and pathophysiological mechanisms have been reviewed extensively in the literature. The pharmaceutical industry has responded to the rising disease burden due to long-COVID through clinical trials addressing specific health concerns. For this analysis, we extracted the clinical trial data from the trial registry clinicaltrials.gov using keywords specific to long-COVID OR post-COVID or post-acute sequelae of COVID-19. This universe of 5146 trials was subjected to step-by-step screening to include industry-sponsored clinical studies addressing long-COVID. We analyzed 74 long-COVID-related clinical trial activities by the pharmaceutical industry as a landscape for the evolution of the trends, clinical outcome assessment methods, and future directions. There are nearly 100 clinical studies conducted to address long-COVID since the pandemic so far. Year by year, consistent investment by pharmaceutical companies suggests that the industry recognizes the unmet needs in this field. An overview of innovative approaches in the landscape, like novel biologic products and medical technologies, has been captured. The investigators have addressed the complexity of health complications through novel assessment methods such as patient-reported outcomes (PRO) and post-COVID related functional assessment scales. Here, we highlight the top PROs and functional scales being used in these clinical studies. The lack of a specific diagnosis method remains the currently unsolved puzzle, and a prerequisite for further research and clinical development in this space.