Since December 2019, an outbreak of novel coronavirus pneumonia has occurred in Wuhan, Hubei Province, People’s Republic of China. As the virus spread, other regions in China and many countries worldwide were also affected by this epidemic, which has been defined as an acute respiratory infectious disease. The situation in various countries outside China continued to worsen due to the coronavirus outbreak. In early 2020, the World Health Organization (WHO) defined the disease as COVID-19 and declared the outbreak a pandemic. Treatment measures include general care and management of severe and critical cases. General care involves bed rest, supportive care to ensure adequate heat, maintaining water and electrolyte balance, monitoring vital signs and oxygen saturation, routine blood and urine tests, biochemical indicators, coagulation function, arterial blood gas analysis, and chest imaging as needed. Effective oxygen therapy measures, antiviral and antibacterial treatments are also administered. Management of severe and critical cases focuses on symptomatic treatment, actively preventing and treating complications, underlying diseases, secondary infections, and providing timely organ function support such as respiratory and circulatory support, renal replacement therapy, plasma therapy, blood purification, immunotherapy, and traditional Chinese medicine for rehabilitative patients. The drug BDB-001 has been developed as an adjunct to conventional treatment for severe and progressive COVID-19 cases.

BDB-001 is an investigational product consisting of a humanized recombinant IgG4k monoclonal antibody. This drug has been developed by Staidson (Beijing) Biopharmaceutical Co. Ltd and Beijing Defengrui Biotechnology Co. Ltd.

The study is an open-label, randomized, add-on trial to conventional therapy involving 60 subjects, with 30 subjects in the drug group and 30 subjects in the control group. During the study, if a subject’s condition deteriorates to a critical illness, they are removed from the group. Subjects’ survival status is monitored for up to 28 days. The treatment duration is 14 days, followed by an additional 14 days for follow-up. Subjects are randomly assigned to one of the following groups: the drug group, which receives conventional therapy plus BDB-001 infusion, or the control group, which receives only conventional therapy.