Expert Consensus on Off-label Use in the Treatment of COVID-19 Infection

Title: Expert Consensus on Off-label Use in the Treatment of COVID-19 Infection
Edition: Original
Classification: Experts consensus
Field: Treatment
Countries and regions: China
Guidelines users: Clinical physicians at all levels (including pharmacy and other relevant fields)
Evidence classification method: Thomson grading system
Development unit: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Registration time: 2023-01-08
Registration number: PREPARE-2023CN017
Purpose of the guideline: In recent years, the treatment of patients with COVID-19 infection has been a major focus in the medical field. Although a number of drugs have been marketed for the treatment of COVID-19 infection in China, with the continuous updating of COVID-19 treatment regimens and the accessibility of drugs, the approved indications, applicable population, dosage, and route of administration of drug label are not sufficient to meet the real-world treatment needs. The off-label use of drugs indeed exists objectively, and its scientificity and rationality is in urgent need of discussion. This consensus aims to conduct evidence-based evaluation of off-label use in the treatment of COVID-19 infection based on the contents of domestic and foreign drug label registration, guideline, consensus, clinical research and other evidence-based medical evidence, and then the expert recommendation of off-label use in the treatment of COVID-19 infection will be formed by the expert group, so as to provide the basis for rational drug use for clinicians and further standardize the clinical application of off-label use of drugs for COVID-19 infection.