ABSTRACT
Background: Sotrovimab is a neutralizing monoclonal antibody (mAb) that seems to remain active against recent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. The evidence on its use in kidney transplant (KT) recipients, however, is limited. Methods: We performed a multicenter, retrospective cohort study of 82 KT patients with SARS-CoV-2 infection {coronavirus disease 2019 [COVID-19]} treated with sotrovimab. Results: Median age was 63 years. Diabetes was present in 43.9% of patients, and obesity in 32.9% of patients; 48.8% of patients had an estimated glomerular filtration rate under 30 mL/minute/1.73 m2. Additional anti-COVID-19 therapies were administered to 56 patients, especially intravenous steroids (65.9%). Sotrovimab was administered early (<5 days from the onset of the symptoms) in 46 patients (56%). Early-treated patients showed less likely progression to severe COVID-19 than those treated later, represented as a lower need for ventilator support (2.2% vs 36.1%; P < .001) or intensive care admission (2.2% vs 25%; P = .002) and COVID-19-related mortality (2.2% vs 16.7%; P = .020). In the multivariable analysis, controlling for baseline risk factors to severe COVID-19 in KT recipients, early use of sotrovimab remained as a protective factor for a composite outcome, including need for ventilator support, intensive care, and COVID-19-related mortality. No anaphylactic reactions, acute rejection episodes, impaired kidney function events, or non-kidney side effects related to sotrovimab were observed. Conclusions: Sotrovimab had an excellent safety profile, even in high-comorbidity patients and advanced chronic kidney disease stages. Earlier administration could prevent progression to severe disease, while clinical outcomes were poor in patients treated later. Larger controlled studies enrolling KT recipients are warranted to elucidate the true efficacy of monoclonal antibody therapies.
ABSTRACT
Background Sotrovimab is a neutralizing monoclonal antibody (MAB) which seems to remain active against recent SARS-CoV-2 variants. However, the evidence on its use in kidney transplant (KT) recipients is limited. Methods We performed a multicenter retrospective cohort study of 82 KT patients with SARS-CoV-2 infection (COVID-19) treated with sotrovimab. Results Median age was 63 years. Diabetes was present in 43.9%, obesity in 32.9% and 48.8% of patients had an estimated Glomerular Filtration Rate <30 mL/min/1.73m2. Additional anti-COVID-19 therapies were administered in 56 patients, especially intravenous steroids (65.9%). Sotrovimab was administered early (<5 days from the onset of the symptoms) in 46 patients (56%). Early-treated patients showed less likely progression to severe COVID-19 than those treated later, represented as a lower need for ventilator support (2.2% vs. 36.1%, P<0.001) or intensive care admission (2.2% vs. 25%;P = 0.002) and COVID-19-related mortality (2.2% vs. 16.7%;P = 0.020). In the multivariable analysis, controlling for baseline risk factors to severe COVID-19 in KT recipients, early use of sotrovimab remained as a protective factor for a composite outcome including need for ventilator support, intensive care and/or COVID-19-related mortality. No anaphylactic reactions, acute rejection episodes, impaired renal function events or non-renal side effects related to sotrovimab were observed. Conclusions Sotrovimab had an excellent safety profile even in high-comorbidity patients and advanced chronic kidney disease stages. Earlier administration could prevent progression to severe disease while clinical outcomes were poor in patients treated later. Larger controlled studies enrolling KT recipients are warranted to elucidate the true efficacy of MAB therapies. Graphical Graphical
ABSTRACT
Purpose: To better know the impact and characteristics of Covid-19 in renal patients, the Spanish Society of Nephrology set up a voluntary registry in March, 2020 Methods: Retrospective observational study of KT recipients included in the Spanish Covid-19 Registry (1st March to 14th November, 2020). We applied Cox multivariate analysis to identify risk factors for mortality and Kaplan-Meier and log rank survival analysis. Results: 1080 KT with Covid-19 were registered, having 937 (86.1%) their outcome reported (cure or death). Most were men (63.2%), mean age 60 years infected a median of 72 months postransplantation. Death occurred in 204 patients. Multivariate analysis found age, neumonia and KT within the last 6 months before Covid-19 were risk factors for mortality and gastrointestinal symptoms were protective. Survival analysis showed significant increasing mortality risk in four subgroups: age<65 years&postransplant time> 6mo (n=526), age<65×<6mo (n=49), age>65× >6mo (n=325) and age>65×<6mo (n=31)($$graphic). Of 1080 cases, 605 correspond to the first wave (1stW until June2020) and 475 to the second wave (2ndW). In the 2ndW, KT were younger (56.4 vs 61.1yr;p=.000), 15.8% were asymptomatic (p=.000) and presented less pneumonia (50.3% vs. 78%;p=.000). Fever, lymphopenia and respiratory symptoms were less frequent but gastrointestinal symptoms similar (30.9% vs. 34.2%;p=.256). Treatment has changed, with more use of remdesivir (p=.000) and steroids (p=.018), no use of ritonavir/lopinavir, hidroxycloroquine andazitromycin (p=.000), and no treatment in (37.1% vs 6.3% in 1stW, p=.000). Hospitalization decreased (89.2% vs. 63.2%;p=.000) but more KT were admitted to critical care units (14.5% vs 20%;p=.058). We found lower mortality (overall 26.4% vs 14.8%;p=.000, hospitalized 29% vs 23%;p=.088). Multivariate analysis of the 2ndW shows again that age, pneumonia and recent transplant (< 6 months) are mortality risk factors. Conclusions: Over a thousand KT have suffered Covid-19 in Spain with a high mortality rate in the first and second waves, mainly related with age, pneumonia and recent transplantation. The interaction between age and time after transplant has to be considered when selecting recipients in the Covid-19 pandemic.