Design and evaluation of clinical trials of COVID-19 vaccine and monoclonal neutralizing antibody / 中国临床药理学与治疗学

ABSTRACT

COVID-19 pandemic has put a huge burden on public health and global economy. Vaccines play an important role in controlling virus transmission and reducing mortality. While monoclonal virus neutralizing antibodies can reduce the viral load, improve symptoms, and prevent the aggravation of the disease from hospitalization. Now hundreds of clinical trials of COVID-19 vaccine and monoclonal neutralizing antibody are in progress. The vaccine focuses on disease prevention, while the neutralizing antibody focuses on disease treatment. There are quite many differences between the two kinds of clinical trials by following different technical guidelines, research purpose, trial design, implementation and outcome assessment. Therefore, it is necessary to summarize the similarities and differences between the clinical trials for the reference of new drug research and development as well as clinical researchers.