Efficacy and safety of sotrovimab for vaccinated or unvaccinated patients with mild-to-moderate COVID-19 in the omicron era

Takehiro Izumo; Nobuyasu Awano; Naoyuki Kuse; Keita Sakamoto; Kohei Takada; Yutaka Muto; Kazushi Fujimoto; Ayae Saiki; Yu Ito; Hiroaki Ota; Minoru Inomata

doi:10.5582/ddt.2022.01036

Original Article

Efficacy and safety of sotrovimab for vaccinated or unvaccinated patients with mild-to-moderate COVID-19 in the omicron era

Takehiro Izumo, Nobuyasu Awano, Naoyuki Kuse, Keita Sakamoto, Kohei Takada, Yutaka Muto, Kazushi Fujimoto, Ayae Saiki, Yu Ito, Hiroaki Ota, Minoru Inomata

Author information

Takehiro Izumo
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Nobuyasu Awano
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Naoyuki Kuse
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Keita Sakamoto
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Kohei Takada
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Yutaka Muto
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Kazushi Fujimoto
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Ayae Saiki
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Yu Ito
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Hiroaki Ota
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.
Minoru Inomata
Department of Respiratory Medicine, Japanese Red Cross Medical Center, Tokyo, Japan.

Keywords: COVID-19, severe acute respiratory syndrome coronavirus 2, adverse event, efficacy, neutralizing antibodies

JOURNAL FREE ACCESS

2022 Volume 16 Issue 3 Pages 124-127

DOI https://doi.org/10.5582/ddt.2022.01036

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Abstract

Although sotrovimab, one of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies has been shown to be effective in patients with mild-to-moderate coronavirus disease 2019 (COVID-19) with risk factors, their efficacy in mRNA COVID-19 vaccinated patients in omicron era is unknown. To evaluate the effectiveness of sotrovimab clinical data from both COVID-19 vaccinated and unvaccinated patients who were hospitalized and receiving sotrovimab at the Japanese Red Cross Medical Center were compared. The efficacy and adverse events were evaluated. Of the total 60 patients enrolled in this study, 45 had received the mRNA COVID-19 vaccine and 15 were unvaccinated. The clinical progression with low nasal cannula or face mask was not significantly different between groups (occurring in one patient in each group; p = 0.44), with no further progression in both groups. The duration of hospitalization was eight days for both groups (p = 0.90). Two patients in each group experienced adverse events (7%, p = 0.26). The results suggested that the efficacy and safety of sotrovimab against mild-to-moderate COVID-19 with risk factors in the omicron era might not be different regardless of the vaccination status. The results of the present study are encouraging; however, further randomized clinical studies are needed.

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