tetano
Editor, Senior Moderator
Am J Obstet Gynecol MFM
. 2022 Jun 4;100673.
doi: 10.1016/j.ajogmf.2022.100673. Online ahead of print.
Outcomes of Pregnant Patients Treated with REGEN-COV during the COVID-19 Pandemic
Natalie H Levey[SUP] 1 [/SUP], Alexandra D Forrest[SUP] 2 [/SUP], Daniella W Spielman[SUP] 2 [/SUP], Kirk A Easley[SUP] 3 [/SUP], Carolynn M Dude[SUP] 2 [/SUP], Martina L Badell[SUP] 2 [/SUP]
Affiliations
Abstract
Background: Pregnant patients with SARS-CoV-2 infection are at increased risk for severe disease including hospitalization, intensive care admission, ventilatory support and death. Although pregnant patients were excluded from investigational trials for pharmacologic treatments for COVID-19 illness, the National Institutes of Health Treatment Guidelines state efficacious treatments should not be withheld from pregnant patients. Infusion of Casirivimab and Imdevimab (REGEN-COV), a monoclonal antibody therapy, was shown to reduce the risk of coronavirus disease 2019 (COVID-19) related hospitalization or death from any cause and resolved symptoms and reduced severe acute respiratory syndrome coronavirus 2 viral load (SARS-CoV-2) more rapidly than placebo. In July of 2021 the Food and Drug Administration released an Emergency Use Authorization for REGEN-COV. Although pregnant persons were not included in the original trials, given the higher risk of morbidity and mortality in the pregnant population, our institution offered REGEN-COV to our pregnant patients beginning in August of 2021. Side effects after REGEN-COV administration are rare and thought to be secondary to COVID infection rather than REGEN-COV.
Objective: The objective of this study was to track the safety and clinical outcomes of unvaccinated pregnant patients who received REGEN-COV and compare these outcomes to a contemporary cohort of patients who tested positive for SARS-CoV-2 and were eligible but did not receive REGEN-COV. Our hypothesis was that REGEN-COV administration during pregnancy is safe, and that pregnant persons who received REGEN-COV would experience less severe COVID-19 respiratory illness by decreasing length of hospital stay, decreasing ICU admission, and decreasing the need for oxygen and other COVID-19 therapeutics.
Study design: This is a retrospective cohort study of pregnant patients who either tested positive for SARS-CoV-2 or had a known exposure to a COVID-19 positive person, and therefore have been eligible for REGEN-COV at our institution. Within this cohort, we compared those who received REGEN-COV to those who did not receive REGEN-COV between March 2021 and October 2021 at Grady Memorial Hospital in Atlanta, Georgia. The main outcomes studied were perinatal outcomes, safety data and the clinical course of SARS-CoV-2 infection.
Results: From March 2021 to October 2021, 86 pregnant people tested positive for SARS-CoV-2 via real time-PCR or had a confirmed exposure. Among this group, 36 received REGEN-COV and 50 did not. There were no instances of infusion rate adjustment or discontinuation, anaphylaxis, or death among those individuals who received REGEN-COV. One individual experienced worsening shortness of breath over 24 hours after administration which was classified as an infusion-related reaction. There were not any significant differences in perinatal outcomes, length of hospitalization, rates of ICU admission, additional pharmacologic treatment for COVID-19, or oxygen requirement between the two groups.
Conclusions: Administration of REGEN-COV is safe in pregnancy and did not increase adverse maternal, neonatal, or obstetrical outcomes. There was not a statistically significant difference in COVID-19 related outcomes in our high-risk population. Given the likely safety of this drug in pregnancy and its known benefits in the non-pregnant population, we advocate for continued use of this therapy and encourage the development of future studies to enroll a larger and more diverse cohort to explore its efficacy further.
Keywords: Adverse events; COVID-19; Casirivimab and Imdevimab; REGEN-COV; SARS-CoV-2; maternal morbidity; monoclonal antibodies; neonatal morbidity; novel therapies; pregnancy.
. 2022 Jun 4;100673.
doi: 10.1016/j.ajogmf.2022.100673. Online ahead of print.
Outcomes of Pregnant Patients Treated with REGEN-COV during the COVID-19 Pandemic
Natalie H Levey[SUP] 1 [/SUP], Alexandra D Forrest[SUP] 2 [/SUP], Daniella W Spielman[SUP] 2 [/SUP], Kirk A Easley[SUP] 3 [/SUP], Carolynn M Dude[SUP] 2 [/SUP], Martina L Badell[SUP] 2 [/SUP]
Affiliations
- PMID: 35671984
- DOI: 10.1016/j.ajogmf.2022.100673
Abstract
Background: Pregnant patients with SARS-CoV-2 infection are at increased risk for severe disease including hospitalization, intensive care admission, ventilatory support and death. Although pregnant patients were excluded from investigational trials for pharmacologic treatments for COVID-19 illness, the National Institutes of Health Treatment Guidelines state efficacious treatments should not be withheld from pregnant patients. Infusion of Casirivimab and Imdevimab (REGEN-COV), a monoclonal antibody therapy, was shown to reduce the risk of coronavirus disease 2019 (COVID-19) related hospitalization or death from any cause and resolved symptoms and reduced severe acute respiratory syndrome coronavirus 2 viral load (SARS-CoV-2) more rapidly than placebo. In July of 2021 the Food and Drug Administration released an Emergency Use Authorization for REGEN-COV. Although pregnant persons were not included in the original trials, given the higher risk of morbidity and mortality in the pregnant population, our institution offered REGEN-COV to our pregnant patients beginning in August of 2021. Side effects after REGEN-COV administration are rare and thought to be secondary to COVID infection rather than REGEN-COV.
Objective: The objective of this study was to track the safety and clinical outcomes of unvaccinated pregnant patients who received REGEN-COV and compare these outcomes to a contemporary cohort of patients who tested positive for SARS-CoV-2 and were eligible but did not receive REGEN-COV. Our hypothesis was that REGEN-COV administration during pregnancy is safe, and that pregnant persons who received REGEN-COV would experience less severe COVID-19 respiratory illness by decreasing length of hospital stay, decreasing ICU admission, and decreasing the need for oxygen and other COVID-19 therapeutics.
Study design: This is a retrospective cohort study of pregnant patients who either tested positive for SARS-CoV-2 or had a known exposure to a COVID-19 positive person, and therefore have been eligible for REGEN-COV at our institution. Within this cohort, we compared those who received REGEN-COV to those who did not receive REGEN-COV between March 2021 and October 2021 at Grady Memorial Hospital in Atlanta, Georgia. The main outcomes studied were perinatal outcomes, safety data and the clinical course of SARS-CoV-2 infection.
Results: From March 2021 to October 2021, 86 pregnant people tested positive for SARS-CoV-2 via real time-PCR or had a confirmed exposure. Among this group, 36 received REGEN-COV and 50 did not. There were no instances of infusion rate adjustment or discontinuation, anaphylaxis, or death among those individuals who received REGEN-COV. One individual experienced worsening shortness of breath over 24 hours after administration which was classified as an infusion-related reaction. There were not any significant differences in perinatal outcomes, length of hospitalization, rates of ICU admission, additional pharmacologic treatment for COVID-19, or oxygen requirement between the two groups.
Conclusions: Administration of REGEN-COV is safe in pregnancy and did not increase adverse maternal, neonatal, or obstetrical outcomes. There was not a statistically significant difference in COVID-19 related outcomes in our high-risk population. Given the likely safety of this drug in pregnancy and its known benefits in the non-pregnant population, we advocate for continued use of this therapy and encourage the development of future studies to enroll a larger and more diverse cohort to explore its efficacy further.
Keywords: Adverse events; COVID-19; Casirivimab and Imdevimab; REGEN-COV; SARS-CoV-2; maternal morbidity; monoclonal antibodies; neonatal morbidity; novel therapies; pregnancy.