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ObjectiveTo evaluate the efficacy and safety of anti-spike monoclonal antibodies (MAb) in the treatment of mild to moderate COVID-19 in high-risk patients who are pregnant. MethodsThe database of patients treated with monoclonal antibodies in the Mayo Clinic Midwest region was reviewed for patients who were pregnant at the time of infusion. Manual chart review was performed to collect demographic details as well as COVID course for both the mother and the infant if delivered. The data are presented using descriptive methods. ResultsWe identified fifty-one pregnant patients with mild to moderate COVID-19 who were treated with MAb (4 with bamlanivimab monotherapy, 3 with bamlanivimab-etesevimab combination, and 44 with the casirivimab-imdevimab combination). No adverse effects were reported, and no patient required COVID-19 related hospitalization. Twenty-nine patients delivered healthy babies, there was one case of intrauterine fetal demise secondary to a congenital Ebstein anomaly (not related to MAb treatment), and twenty-one were uncomplicated pregnancies. ConclusionMAb infusions were well tolerated in pregnant patients considered at high risk for COVID-19 complications, with no observed adverse effects to mother or fetus. Although preliminary data suggest MAb therapy in pregnancy is safe, further research is recommended to fully assess safety and efficacy in pregnancy. TEACHING POINTSO_LIAnti-spike monoclonal antibody therapy is well tolerated in high-risk pregnant patients with mild to moderate COVID-19 C_LIO_LINo adverse effects of anti-spike monoclonal antibody administration were observed in either the mother or fetus. C_LI
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Breakthrough COVID-19 may occur in fully vaccinated persons. In this cohort of 1395 persons (mean age, 54.3 years; 60% female; median body mass index, 30.7) who developed breakthrough COVID-19, there were 107 (7.7%) who required hospitalization by day 28. Hospitalization was significantly associated with the number of medical comorbidities. Anti-spike monoclonal antibody treatment was significantly associated with a lower risk of hospitalization (Odds Ratio: 0.227; 95% confidence interval, 0.128 - 0.403; p<0.001). The number needed to treat to prevent one hospitalization was 225 among the lowest-risk patient group compared to 4 among the groups with highest numbers of medical comorbidity. summaryBreakthrough COVID-19 may occur among vaccinated individuals with a high number of medical comorbidities, especially during the surge of SARS-CoV-2 Delta variant. Treatment with anti-spike monoclonal antibody was associated with significantly lower rates of hospitalization and oxygen supplementation.
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ObjectiveTo describe the clinical data from the first 107 patients seen in the Mayo Clinic Post COVID-19 Care Clinic (PCOCC). Patients and MethodsAfter IRB approval, we reviewed the charts of 107 patients seen between January 19, 2021 and April 29, 2021 in the Mayo Clinic Post COVID Care Clinic (PCOCC) in order to describe the first 107 patients treated through the Mayo Clinic PCOCC. Data was abstracted from the electronic medical record into a standardized database to facilitate analysis. Phenotypes of patients seen in the PCOCC clinic were identified by expert review of predominant symptom clusters. ResultsThe majority of patients seen in our clinic were female (75%, 80/107), and the median age at presentation was 47 years (interquartile range [IQR] 37, 55). All had Post Acute Sequelae of SARS-CoV-2 infection (PASC) with six clinical phenotypes being identified - fatigue predominant (n=68), dyspnea predominant (n=23), myalgia predominant (n=6), orthostasis predominant (n=6), chest pain predominant (n=3), and headache predominant (n=1). The fatigue-predominant phenotype was more common in women (84%, p=0.006) and the dyspnea-predominant phenotype was more common in men (52%, p=0.002). IL-6 was elevated in 61% of patients (69% of women, p=0.0046) which was statistically discordant with elevation in CRP and ESR which was identified in 17% and 20% of cases respectively (p<0.001). Four PASC phenotypes (fatigue-predominant, myalgia-predominant, orthostasis predominant, and headache-predominant) were associated with central sensitization (CS), and higher IL-6 levels than those phenotypes not associated with CS (p=0.013). Patients with CS phenotypes after COVID-19 infection (post COVID syndrome) were predominantly female (80%, p=0.0085). ConclusionIn our post COVID clinic, we observed several distinct clinical phenotypes. Fatigue-predominance was the most common presentation and was associated with elevated IL-6 levels and female gender. Dyspnea-predominance was more common in men and was not associated with elevated IL-6 levels. IL-6 levels were significantly elevated in patients with PASC and discordant with ESR and CRP, particularly in those with central sensitization phenotypes.
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The post-COVID syndrome is estimated to occur in up to 10% of patients who have had COVID-19. This condition manifests as lingering symptoms which persist for weeks to months after resolution of the acute illness. The syndrome is poorly understood and efforts are just beginning to appropriately characterize the symptoms expressed by this population. We present a population of patients with persistent symptoms as measured by a select number of PROMIS surveys (i.e. fatigue, sleep, pain, physical functioning, and social roles). We believe this to be the first use of the PROMIS survey data collected in this population and one of the first to attempt to measure social dysfunction secondary to the post-COVID syndrome. Our patient population is notably younger (30.9% were between 40-59 years of age), with a majority being female (60.5%). They also reported deficits in social roles (34.5%), and greater fatigue (14.7%), and pain (15.9%); along with a variety of disease severity ranging from asymptomatic to requiring admission. Despite this increased heterogeneity of population, the symptomatology of the post-COVID syndrome is preserved. These findings differ significantly from previously published data that demonstrated that outpatients can have duration of post-COVID syndrome similar to those who were hospitalized.
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BackgroundClinical data to support the use of bamlanivimab for the treatment of outpatients with mild to moderate coronavirus disease-19 (COVID-19) is needed. Methods2,335 patients who received single-dose bamlanivimab infusion between November 12, 2020 to February 17, 2021 were compared with a propensity-matched control of 2,335 untreated patients with mild to moderate COVID-19 at Mayo Clinic facilities across 4 states. The primary outcome was the rate of hospitalization at days 14, 21 and 28. ResultsThe median age of the population was 63; 47.3% of the bamlanivimab-treated cohort were [≥]65 years; 49.3% were female. High-risk characteristics included hypertension (54.2%), body mass index [≥]35 (32.4%), diabetes mellitus (26.5%), chronic lung disease (25.1%), malignancy (16.6%), and renal disease (14.5%). Patients who received bamlanivimab had lower all-cause hospitalization rates at days 14 (1.5% vs 3.5%; Odds Ratio [OR], 0.38), 21 (1.9% vs 3.9%; OR, 0.46), and 28 (2.5% vs 3.9%; OR, 0.61). Secondary exploratory outcomes included lower intensive care unit admission rates at days 14 (0.14% vs 1%; OR, 0.12), 21 (0.25% vs 1%; OR: 0.24) and 28 (0.56% vs 1.1%; OR: 0.52), and lower all-cause mortality at days 14 (0% vs 0.33%), 21 (0.05% vs 0.4%; OR,0.08) and 28 (0.11% vs 0.44%; OR, 0.01). Adverse events were uncommon with bamlanivimab, occurring in 19/2355, most commonly fever (n=6), nausea (n=5), and lightheadedness (n=3). ConclusionsAmong high-risk patients with mild to moderate COVID-19, treatment with bamlanivimab was associated with a statistically significant lower rate of hospitalization compared with usual care. FundingMayo Clinic.