Treat COVID-19 with monoclonal antibodies during pregnancy

In a recent study posted on medRxiv* Preprint server, researchers Effectiveness Safety of Monoclonal Antibodies (mAbs) for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy.

Various studies have reported hospitalization and reduced mortality in patients with mild to moderate coronavirus disease 2019 (COVID-19) infection. However, extensive research is needed to estimate the efficacy and side effects associated with mAb treatment during pregnancy.

About research

In this study, the researchers estimated the percentage of post-treatment mAb-related adverse events in pregnant women infected with SARS-CoV-2 and the associated safety outcomes of those who gave birth.

This study consisted of people over the age of 12 who were eligible for mAb treatment with a pregnancy episode.Participants can use the polymerase chain reaction or antigen Tests from April 30, 2021 to January 21, 2022. Prior to December 23, 2021, all participants treated with mAb received the drug via a centralized management system. From December 23, 2021 to January 21, 2022, all participants were treated with sotrovimab due to increased infection with the SARS-CoV-2 omicron variant.

Patients who received mAb treatment at an emergency medical facility, outpatient infusion center, or obstetric triage area were considered to have received mAb treatment, and patients who were not treated with mAb were considered untreated. In addition, patients treated in the obstetrics and emergency department were considered outpatients. The treated and untreated groups underwent follow-up on the day of mAb treatment and 28 days starting the day after the SARS-CoV-2 positive diagnosis, respectively.

The main safety outcomes are those who have been treated with mAbs and have experienced obstetric-related outcomes such as birth weight, gestational age at birth, neonatal intensive care unit (NICU) admission, stillbirth, and diagnosis of hypertension. It included the percentage of adverse effects related to mAbs. Birth time, maternal ICU visits, and severe maternal morbidity. The main outcome to determine the efficacy of mAb was a risk-adjusted correlation between mAb treatment and COVID-19-related childbirth, COVID-19-related hospitalization or ED visits, or a combination of mortality rates. ..

The team defined COVID-19-related hospitalizations as prepartum hospitalizations for oxygenation or respiratory support. Delivery associated with COVID-19 was defined as delivery induced by complications associated with COVID-19, including pathological SARS-CoV-2 associated placentitis and fetal distress due to maternal respiratory failure. .. In addition, the side effects of this study included 28 days of non-COVID-19-related hospitalization and the proportion of individual elements of the combined result.

result

The results of the study showed that 58% of the 944 eligible pregnant women received mAb treatment. The median age of the patient cohort was 30, 79.5% were Caucasian and 62% were fully vaccinated, but some patients reported comorbidities. In particular, patients treated with mAbs were older, more likely to report a history of infertility, and were fully vaccinated. The median gestation period while receiving diagnosis or treatment for COVID-19 was 179 days. Of the treated cohort, 58% were treated with mAb within 4 days of the onset of COVID-19 symptoms, 69% of patients were treated with sotrovimab, 20% were treated with kacilibimab and imdebimab, and 11% were treated with bablanivimab and etesebimab. I did.

Almost 2% of treated patients experienced mild drug-related adverse events, but none suffered from severe infusion-related reactions. Of the 276 births during the follow-up period, this study found significant differences between the treated and untreated groups in terms of birth weight, gestational age at birth, NICU admission, stillbirth, and hypertension at birth. Was not seen. Maternal ICU visits, and severe maternal morbidity.

In the primary analysis, the team observed a composite of 28-day risk adjustment frequencies for COVID-19-related results. It was 4 per 100 in the mAb-treated group and 3.7 per 100 in the non-treated group. .. In addition, no deaths were reported in patients treated with mAbs, but one death was reported in the untreated group. In particular, the number of non-COVID-19-related hospitalizations in the mAb-treated group was higher than that in the non-treated group, indicated by preterm birth and intrahepatic contractions. Cholestasis of pregnancy..

Conclusion

In summary, the study results showed that post-treatment adverse events with mAb are mild and rare in pregnant women suffering from mild to moderate SARS-CoV-2 infection. In addition, mAb treatment correlated with comparable 28-day combined COVID-19-related results and more non-COVID-19-related hospitalizations compared to the untreated cohort.

*Important Notices

medRxiv publishes unpeer-reviewed preliminary scientific reports and should not be considered definitive, guide clinical / health-related behaviors, or be treated as established information.