Clinical observation of neutralizing antibody DXP-604 for treatment critical COVID-19 patients infected with SARS-CoV-2 Delta variant.

ABSTRACT

From January to March 2022, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Delta (B.1.617.2) infection was prevalent in Yuzhou and Zhengzhou. DXP-604 is a broad-spectrum antiviral monoclonal antibody, which has excellent viral neutralization ability in vitro and a long half-life in vivo, with good biosafety and tolerability. Preliminary results showed that DXP-604 can accelerate recovery from Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 Delta variant in hospitalized patients with mild to moderate clinical symptoms. However, the efficacy of DXP-604 has not been fully studied in high-risk severe patients. Here, we prospectively enrolled 27 high-risk patients, two groups were divided, in addition to receiving standard of care (SOC), 14 of them additionally received the neutralizing antibody DXP-604 therapy, and another 13 intensive care unit (ICU) patients simultaneously underwent SOC as a control group matched for age, gender, and clinical type. The results revealed lower C-reactive protein, interleukin-6, lactic dehydrogenase and neutrophil counts, and higher lymphocyte and monocyte counts from Day 3 post-DXP-604 treatment compared with SOC treatment. Besides, thoracic CT images showed improvements in lesion areas and degrees, along with changes in blood inflammatory factors. Moreover, DXP-604 reduced the invasive mechanical ventilation and mortality of high-risk SARS-CoV-2 infected patients. The ongoing clinical trials of DXP-604 neutralizing antibody will clarify its utility as a new attractive countermeasure for high-risk COVID-19.