Outcomes of pregnant women exposed to Sotrovimab for the treatment of COVID-19 in the BA.1 Omicron predominant era (PRESTO)

• Published in: BMC infectious diseases Vol. 23; no. 1; pp. 258 - 5
• Main Authors: Tuan, Jessica J., Sharma, Manas, Kayani, Jehanzeb, Davis, Matthew W., McManus, Dayna, Topal, Jeffrey E., Ogbuagu, Onyema
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 26.04.2023; BioMed Central; BMC
• Subjects: Adult; Allergic reactions; Antibodies, Monoclonal, Humanized - adverse effects; BNT162 Vaccine; Body mass index; Body size; Care and treatment; Clinical outcomes; Complications and side effects; Coronaviruses; COVID-19; COVID-19 vaccines; Demographics; Diabetes; Diabetes mellitus; Diagnosis; Disease control; Dosage and administration; Electronic health records; Electronic medical records; Emergency medical care; Emergency medical services; Female; Fetuses; Health aspects; Health services; HIV; Hospitalization; Human immunodeficiency virus; Humans; Hypersensitivity; Immunization; Infant, Newborn; Infectious diseases; Medical records; Medical screening; Monoclonal antibodies; mRNA; Neonates; Obstetrics; Omicron; Patients; Preeclampsia; Pregnancy; Pregnancy complications; Pregnancy Complications, Infectious - drug therapy; Pregnancy, Complications of; Pregnant Women; Premature labor; Public health; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Sickle cell anemia; Sickle cell disease; Sotrovimab; Vaccination; Womens health; United States; United States > US; Connecticut; COVID-19; Pregnancy; Monoclonal antibodies; Sotrovimab; Omicron
• ISSN: 1471-2334; 1471-2334
• DOI: 10.1186/s12879-023-08198-9

Sotrovimab, a monoclonal antibody with efficacy against SARS-CoV-2 including certain Omicron variants, has been used in treatment of mild-moderate COVID-19. Limited data exists regarding its use in pregnant women. Electronic medical record review of pregnant COVID-19 patients treated with sotrovimab from 12/30/21 - 1/31/22 (Yale New Haven Health Hospital System [YNHHS]) was performed. Included were pregnant individuals ≥ 12 years, weighing ≥ 40 kg, with positive SARS-CoV-2 test (within 10 days). Those receiving care outside YNHHS or receiving other SARS-CoV-2 treatment were excluded. We assessed demographics, medical history, and Monoclonal Antibody Screening Score (MASS). The primary composite clinical outcome assessed included emergency department (ED) visit < 24 h, hospitalization, intensive care unit (ICU) admission, and/or death within 29 days of sotrovimab. Secondarily, adverse feto-maternal outcomes and events for neonates were assessed at birth or through the end of the study period, which was 8/15/22. Among 22 subjects, median age was 32 years and body mass index was 27 kg/m . 63% were Caucasian, 9% Hispanic, 14% African-American, and 9% Asian. 9% had diabetes and sickle cell disease. 5% had well-controlled HIV. 18%, 46%, and 36% received sotrovimab in trimester 1, 2, and 3, respectively. No infusion/allergic reactions occurred. MASS values were < 4. Only 12/22 (55%) received complete primary vaccination (46% mRNA-1273; 46% BNT162b2; 8% JNJ-78,436,735); none received a booster. Pregnant COVID-19 patients receiving sotrovimab at our center tolerated it well with good clinical outcomes. Pregnancy and neonatal complications did not appear sotrovimab-related. Though a limited sample, our data helps elucidate the safety and tolerability of sotrovimab in pregnant women.