OBJECTIVES: The outbreak of coronavirus disease 2019 (COVID-19) has led to over 250 million cases and 5 million deaths worldwide. Despite limited understanding of disease pathogenesis and pathophysiology, clinical trials have been conducted since early 2020 to evaluate vaccines and treatments. This research aims to identify outcomes examined in clinical trials of COVID-19 medicines developed on an accelerated timeline.

METHODS: Appraisal reports for medicines for COVID-19 publicly available by December 15, 2021, were identified on the websites of the European Medicines Agency (EMA), vaccine committees, and health technology assessment (HTA) bodies. Searches for clinical and health-related quality-of-life (HRQoL) outcomes were conducted in all reports. Searches for health economics (HE) outcomes were limited to the HTA reports.

RESULTS: Information on clinical trial outcomes was retrieved for all EMA-authorized medicines [four vaccines (Comirnaty®, SpikeVax®, Vaxzevria®, and COVID-19 Vaccine Janssen®) and three treatments (Veklury® and two monoclonal antibodies)], and for six out of 11 medicines under EMA review. The primary outcomes examined in vaccine trials pertained to vaccine efficacy (i.e., reduction of number of symptomatic cases). For treatments, the primary and secondary outcomes varied by study and pertained mostly to disease progression (e.g., hospitalization), time to hospital discharge, all-cause mortality, sides effects, and change in viral load. No HRQoL or HE outcomes were reported in any vaccine committee or HTA reports identified.