key: cord-0824080-os4tp69k authors: Chavarot, Nathalie; Melenotte, Clea; Amrouche, Lucile; Rouzaud, Claire; Sberro-Soussan, Rebecca; Pavie, Juliette; Martinez, Frank; Pouvaret, Anne; Leruez-Ville, Marianne; Cantin, Delphine; Fourgeaud, Jacques; Delage, Claire; Vimpere, Damien; Peraldi, Marie Noëlle; Legendre, Christophe; Lanternier, Fanny; Zuber, Julien; Scemla, Anne; Anglicheau, Dany title: Early treatment with sotrovimab monoclonal antibody in kidney transplant recipients with Omicron infection date: 2022-04-12 journal: Kidney Int DOI: 10.1016/j.kint.2022.04.003 sha: f655c352e66b13581418f92dea293bea812ab987 doc_id: 824080 cord_uid: os4tp69k nan Early data about COVID-19 related to SARS-CoV-2 Omicron variant (B.1.1.529) suggest that it may be less severe than prior variants of concern in the general population [1] [2] [3] . However, our preliminary data (under review) about Omicron infection in kidney transplant recipients (KTRs) suggest that the disease is associated with severe forms in this vulnerable population with low post-vaccinal immune responses. Sotrovimab monoclonal antibody has been demonstrated to reduce disease progression in high-risk patients with mild to moderate COVID-19 before Omicron era 4 . Recent studies assessed that, in contrast with other monoclonal antibodies, it remained active against the Omicron spike 5 . We aimed to compare the clinical outcomes of the first 25 KTRs treated with sotrovimab for mild to moderate Omicron COVID-19 to KTRs who did not receive sotrovimab. Sotrovimab was available in our institution (Necker Hospital (Paris, France)) from January 25, 2022. KTRs with high-risk for progression of COVID-19 (because of older age (≥ 55 years) or because they had at least one of the following risk factors: diabetes, obesity (body mass index (BMI) > 30, estimated glomerular filtration rate < 30 mL/min), coronary artery disease, or chronic lung disease) who presented with mild to moderate Omicron COVID-19 after this date were treated with sotrovimab (a single 500-mg, 1-hour infusion). Control group consisted in the 100 first KTRs who experienced Omicron infection before January 25. We excluded patients who received pre-exposure prevention with tixagévimab/cilgavimab. Table 1) . 16/23 (69.6%) patients with available data had a COVID-19 serostatus predictive of a poor protection against Omicron (seronegative or weakly seropositive (<264 BAU/mL) J o u r n a l P r e -p r o o f and/or treated with casirivimab/imdevimab. Antibody titers of seropositive patients are available in Supplemental table S1). No infusion-related reaction was observed. Median time between symptoms onset and sotrovimab infusion was 5 (3-9) days. (Eight patients (32%) were treated after Day 5 (up to Day 13) of symptoms onset). Although sotrovimab-treated patients presented more risk factors associated with severe COVID-19 (significantly more men and more underlying comorbidities) ( Table 1) , Omicron infection was less severe (less mortality and less severe disease (mortality and/or intensive care unit (ICU) admission) compared with controls (Figure 1) . In sotrovimab group, 4 (16.0%) patients were hospitalized, including 1 patient required intensive care unit (ICU) and no patients died. The patient admitted in ICU received sotrovimab at day 11 after symptoms onset. In contrast, 35 patients (35%) were hospitalized for Omicron disease in the control group. Among them, 17% required ICU (9% needed mechanical ventilation) and 11% died. Omicron infection appears to be severe in KTRs. Our study reports the first cohort of KTRs treated with sotrovimab for Omicron infection. Although these patients presented high-risk for progression to severe disease, the severity of COVID-19 was lower than the historical control group, concordant with findings in the general population. Interestingly, the rate of patients with SARS-CoV-2 positive immune response was similar (and low) in both groups. Despite its retrospective character and the relatively short follow-up, our findings show that the sotrovimab neutralizing anti-SARS-CoV-2 antibody can prevent severe COVID-19 in KTRs infected with the Omicron variant and can be safely proposed in outpatients KTRs. Supplementary Characteristics and Outcomes of Hospitalized Patients in South Africa During the COVID-19 Omicron Wave Compared With Previous Waves Estimates of SARS-CoV-2 Omicron Variant Severity in Ontario Trends in Disease Severity and Health Care Utilization During the Early Omicron Variant Period Compared with Previous SARS-CoV-2 High Transmission Periods -United States Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab The Omicron variant is highly resistant against antibodymediated neutralization: Implications for control of the COVID-19 pandemic The authors of this manuscript have no conflicts of interest.The data that support the findings of this study are available from the corresponding author upon reasonable request. Dataset available from the corresponding author at Nathalie.chavarot@aphp.fr