Sotrovimab Use for COVID-19 Infection in Pregnant Kidney Transplant Recipient.

Abstract

Coronavirus disease 2019 (COVID-19) infection in kidney transplant patients has variable outcomes. Pregnancy in kidney transplant patient has more risk for fetomaternal complications, including preeclampsia, hypertension, high rate of cesarean section, and preterm delivery. Studies of COVID-19 infection in pregnant patients revealed similar outcomes to general population. The National Institutes of Health recommend anti–severe acute respiratory syndrome coronavirus 2 antibodies use in mild to moderate COVID-19 infection in pregnant and immunocompromised patients.1 Bamlanivimab, casirivimab–imdevimab, and sotrovimab received emergency use authorization for high-risk patients. Sotrovimab is a human immunoglobulin G-1 (immunoglobulin G1-kappa) monoclonal antibody (mAb) that needs to be administered within 10 d of symptoms onset as 500 mg single intravenous infusion dose for 30 min. Its safety and efficacy in pregnant ladies are not known. We described successful management of COVID-19 infection in a 39-y-old pregnant multiparous (gravid 4, para 3) kidney transplant patient. She had living donor transplant in 2012 and had chronic allograft dysfunction (chronic kidney disease stage IIIb, estimated glomerular filtration rate 42). She did not receive COVID-19 vaccine and was on immunosuppressive daily medications, including azathioprine 125 mg, tacrolimus 5 mg sustained release, and prednisolone 5 mg. She presented with a 2-d history of fever, runny nose, sore throat, fatigue, and nausea at 27 wk of pregnancy. She was diagnosed with COVID-19 infection and her oxygen saturation was normal (Spo2: 98%). The initial laboratory investigations revealed creatinine: 137 µmol/L, white blood cell count: 6.2 × 109/L, anemia hemoglobin: 89 g/L, thrombocytopenia: 121 × 109/L, lymphopenia: 0.73 × 109/L, C-reactive protein: 47 mg/L, D-dimer: 1.9 mg/L, and ferritin: 230 µg/L. She received 1 dose of sotrovimab therapy 500 mg intravenously without adjustment of immunosuppression medications. There was no reported fetomaternal complications. She was managed at home and followed-up via telemedicine service. She had complete recovery of COVID-19 infection after 2 wk. At 35 wk of pregnancy, she had induction of labor and delivered a healthy baby boy (low birth weight: 2270 g). We did not assess the COVID-19 antibodies in amniotic fluid, breast milk, or the neonate. A follow-up monthly for 3 mo revealed stable renal function and no major adverse events. The use of anti–severe acute respiratory syndrome coronavirus 2 mAbs in solid organ transplant patients is well established, whereas limited data are available for pregnant patients and their pregnancy outcomes.2 Recently, a study revealed no adverse events of 4 pregnant patients (nontransplant) who received casirivimab plus imdevimab for mild to moderate COVID-19 infection.3 The mean age was 28 y and gestational ages ranged from 11 to 32 wk. Hospitalization was not required and 2 patients had delivery outcomes.3 Thilagar et al (preprint) reported outcomes of 51 pregnant patients treated with antispike mAbs for COVID-19 infection. The mean maternal age was 31.1 y and mean gestational age was 180.1 d. No fetomaternal complications were reported and 29 patients had healthy babies4 (Table 1). TABLE 1. - Use of antispike monoclonal antibodies for COVID-19 infection during pregnancy Study/clinical data AlKindi et al (2021) Hirshberg et al 3 Thilagar et al 4 Mayer et al 5 Cases/age 39-y-old pregnant kidney transplant patient 4 pregnant cases, mean age 28 y 51 pregnant patients, mean age 31.1 y 2 pregnant patients (36 y old and 29 y old) Gestational age at time of therapy 27 wk(2nd trimester) Gestational ages ranged from 11 to 32 wkFirst trimester (n = 1), 3rd trimester (n = 3) Mean gestational age was 180.1 d (1st trimester [n=4], 2nd trimester [n = 17], 3rd trimester [n = 30]) Second trimester (n=1)Third trimester (n = 1) Severity of COVID-19 infection Mild Mild (n = 1)Moderate (n = 3) Mild to moderate COVID-19 Moderate (n = 2) Antispike monoclonal antibodies Sotrovimab (500 mg IV once) Casirivimab plus imdevimab (n = 4) Bamlanivimab monotherapy (n = 4),bamlanivimab–etesevimab (n = 3),casirivimab–imdevimab (n = 44) Casirivimab and imdevimab (n = 2) Hospitalization/additional COVID-19 therapy No No No No Adverse events No No No No Pregnancy/fetal outcomes Induction of labor at 35 wk, healthy baby 2 patients had delivery outcomes (term delivery, 1 preterm because of trauma)2 patients were still pregnant 29 patients had healthy babies21 uncomplicated pregnancies at time of study1 case intrauterine fetal demise (congenital Ebstein anomaly) 1 patient delivered and the baby had transient tachypnea of the newborn (COVID-19 negative) COVID-19, coronavirus disease 2019; IV, intravenous. We report the first case of sotrovimab therapy in pregnant kidney transplant patients globally. The use of mAbs for COVID-19 infection in pregnant patients has favorable outcomes and larger studies are needed.