ABSTRACT
Background. We studied the safety and efficacy of the use of monoclonal antibodies (MAB) against SARS-CoV-2 in pregnant women who developed COVID-19 infection. Methods. We conducted a cross-sectional descriptive multi-center study of pregnant patients who developed SARS-CoV-2 infection from January 2021 to January 2022 and received MAB therapy. Primary outcomes assessed were infusion-related adverse events and pregnancy outcomes within one month of MAB infusion. The secondary outcomes assessed were hospitalization and ICU admission for COVID19 infection and thirty-day all-cause mortality. Results. 141 patients were included in the study (median age 33 +/- 5.3 SD, median BMI 28.9 +/- 8.42 SD). In terms of COVID vaccination status, 49.6% received one dose, 36.1% were fully vaccinated, and 7% received the booster dose. Most patients received casirivimab/imdevimab (105, 74.5%) followed by sotrovimab (33, 23.4%). Four patients developed adverse reactions to MAB infusion (two grade-2 reactions and two grade-1 reactions as per the National cancer institute infusion reaction grading criteria). Only one patient (0.7%) was hospitalized for COVID-19 infection, however, she was not hypoxic nor required ICU admission. Five patients delivered within four weeks of MAB administration, however, four of those patients were of gestational age > 37 weeks. Data for 30-day all-cause mortality was available on 88.7% (125) of the patients and data for 30-day pregnancy adverse outcomes was available on 86.5% (122) of the patients due to lack of follow-up within the Health System. There was no reported 30-Day all-cause mortality within the cohort. Two patients (1.4%) had premature rupture of the membrane and one patient (0.7%) had premature delivery within 30 days of receiving MAB. Two patients had preeclampsia (1.4%) and one patient (0.7%) was admitted for evaluations of decreased fetal movements. Conclusion. Administration of monoclonal antibodies against SARS-CoV-2 was well tolerated during pregnancy. Only 4 out of 141 (2.8%) had mild to moderate infusion-related reactions. The 30-day pregnancy adverse outcomes observed were well below the mean background rate. There was no reported mortality among MAB recipients and only one patient was hospitalized for mild COVID19 infection.
ABSTRACT
Background. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infected patients experience systemic inflammation and respiratory distress, which appears to be associated with increased cytokine release. During the peak of coronavirus disease 2019 (COVID-19), tocilizumab was used to treat critically ill patients with potential cytokine storm. However, tocilizumab has an increased risk of developing serious infections. Methods. This retrospective observational chart review was approved by Institutional Review Board and evaluated patients admitted from March to November 2020, who were SARS-CoV-2 positive and received tocilizumab for the treatment group and no tocilizumab for the control group. The primary endpoint is usage of antimicrobials. The secondary endpoints are development and outcomes of secondary infections and hospital length of stay and mortality. Chi-square test was used for categorical data and Mann-Whitney test was used for continuous data. Results. A total of 160 patients were included in analysis, with 80 in each arm. 60% of patients in the treatment group required antibiotics compared to 35% in the control group (p = 0.0015), with the highest usage of anti-MRSA coverage, betalactams, cephalosporins, and carbapenems in both groups. Antifungal therapy was required in 21.3% of patients in the tocilizumab group compared to 6.3% in the control group (p = 0.0059), with echinocandins being the most used class in both groups. The median days of antimicrobial use in the tocilizumab group was 14 (IQR 7, 24.5) compared to 9 (IQR 6.5, 19) in the control group (p = 0.3346). In the treatment group, 60% of patients developed a secondary infection compared to 35% of patients in the control group (p < 0.0017). Secondary infection treatment failure was observed in 75% of tocilizumab patients compared to 60.7% of control patients (p = 0.1910). In hospital mortality was 50% in patients who received tocilizumab compared to 27.5% in the control group (p < 0.0039). Conclusion. Patients on tocilizumab received more antimicrobials, but with a similar spectrum of antimicrobial coverage. Patients who received tocilizumab had higher odds of developing secondary infections and expiring during their hospital stay. There were similar durations of antimicrobial therapy and treatment outcomes.