USA – Guidance : Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide sponsors and investigators with considerations for
approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID19 in outpatient adult and adolescent subjects. This guidance is not intended for development programs evaluating products to treat or prevent postinfectious COVID-19 conditions such as multisystem inflammatory syndrome in children or to development programs for preventative vaccines. This guidance does not address considerations for clinical trial design other than those pertaining to the measurement and analysis of COVID-19-related symptoms among outpatients…