ABSTRACT
Background: Fever is a common clinical manifestation of COVID-19 infection. Fever has also been associated with unmasking Brugada pattern ECG in patients and may result in life-threatening arrhythmia. Little is known regarding COVID-19 associated Brugada pattern ECG. There is paucity of data and guidance in how to manage these patients. Method(s): To identify all published case reports, the latest Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist was followed. A literature search was conducted using PubMed, EMBASE, and Scopus through September 2021. A systematic review was performed to identify the incidence, clinical characteristics, and management outcomes of COVID-19 patients with a Brugada pattern ECG. Result(s): A total of 18 cases were collected. The mean age was 47.1 years and 11.1% were women. No patient had prior confirmed diagnosis of Brugada syndrome. The most common presenting clinical symptoms were fever (83.3%), chest pain (38.8%), shortness of breath (38.8%), and syncope (16.6%). All 18 patients presented with type 1 Brugada pattern ECG. Four patients (22.2%) underwent left heart catheterization, and none demonstrated the presence of obstructive coronary disease. The most common reported therapies included antipyretics (55.5%), hydroxychloroquine (27.7%), and antibiotics (16.6%). One patient (5.5%) died during hospitalization. Three patients (16.6%) who presented with syncope received either an implantable cardioverter defibrillator or wearable cardioverter defibrillator at discharge. At follow up, thirteen patients (72.2%) had resolution of type 1 Brugada pattern ECG. Conclusion(s): COVID-19 associated Brugada pattern ECG is rare. Most patients may see resolution of the ECG pattern once their symptoms have improved. Increased awareness and timely use of antipyretics is warranted in this population.
ABSTRACT
Background:A previous report showed that a single 1200 mg subcutaneous (SC) dose of casirivimab and imdevimab (cas/imd) prevented symptomatic COVID-19 by 81.4% and reduced all SARS-CoV-2 infections (symptomatic and asymptomatic) by 66.4% in household contacts living with recently infected individuals over a 28-day period. While highly effective vaccines now exist for the prevention of COVID-19, a significant unmet need remains in patients who are unable to mount or maintain an adequate immune response to vaccination. Here we present additional results from 7-month follow-up period of the aforementioned study. Methods: In this randomized, double-blind, placebo-controlled Phase III trial, asymptomatic participants exposed to a SARS-CoV-2-infected household member were randomized 1:1 to a single SC dose of placebo or 1200 mg cas/imd (600 mg of each monoclonal antibody). Efficacy analyses include participants who were RT-qPCR negative for SARS-CoV-2 (no current infection) and seronegative for SARS-CoV-2 (no prior infection) at baseline. The trial consisted of a primary efficacy assessment period of 28 days (Month 1) and a 7-month follow-up period (Months 2-8). Results: Results from 842 placebo and 841 cas/imd RT-qPCR negative/seronegative enrolled participants (data through 04Oct2021, prior to emergence of Omicron) are presented. During the entirety of the 8-month study, cas/imd reduced the risk of symptomatic SARS-CoV-2 infections by 81.2% versus placebo (nominal P<0.0001;Table) and all SARS-CoV-2 infections (symptomatic and asymptomatic) by 68.2% versus placebo (nominal P<0.0001;Table). During Months 2-5, the risk of symptomatic and all infections were reduced by 100% and 89.5%, respectively (nominal P<0.0001). During Months 6-8 there was a resumption of symptomatic and all SARS-CoV-2 infections in the cas/imd group (19.9%;nominal P=0.6411 and 30.7%;nominal P=0.3967 risk reduction, respectively). Fewer cas/imd participants had a medically-attended visit versus placebo during the 8-months (1/841 [0.1%] vs 16/842 [1.9%], respectively). No new safety signals were identified for cas/imd during the follow-up period. Conclusion: During the 8-month study period, a 1200 mg SC dose of cas/imd prevented SARS-CoV-2 infections, with maximal protection through Month 5. The prolonged protection supports the use of cas/imd for the long-term prevention of COVID-19 against susceptible variants, offering a pre-exposure prophylaxis strategy for individuals who are unlikely to respond or be protected by vaccination.
ABSTRACT
Background: Extracorporeal membrane oxygenation (ECMO) is utilized as rescue therapy in patients diagnosed with coronavirus disease 2019 (COVID-19) with refractory respiratory or cardiogenic failure. Systemic anticoagulation with heparin remains the initial choice for thromboembolism prophylaxis in ECMO-treated patients. However, heparin carries the risk of severe complications, such as heparin-induced thrombocytopenia (HIT), and acquired antithrombin deficiency. Bivalirudin has been suggested as an alternative anticoagulant since it neither requires anti-thrombin III monitoring nor triggers HIT. Purpose: There is very limited data on the utilization of bivalirudin in patients with COVID-19 treated with ECMO. We report the clinical safety and efficacy of using bivalirudin at our institution. Methods: We retrospectively reviewed 17 patients diagnosed with COVID-19, who were treated with ECMO from 7/31/2020 to 12/20/2020. All patients received bivalirudin for thromboprophylaxis while on ECMO support. Results: The mean age of our study cohort was forty-five years. Thirteen patients (76.4%) were of either Hispanic or African American descent. Of the seventeen patients, six (35.3%) patients developed deep venous thrombosis and one (5.9%) patient developed pulmonary embolism. Two (11.8%) patients developed a clotted circuit that required exchange. Fifteen (88.2%) patients had hemorrhage requiring transfusion with the gastrointestinal tract as the most common bleeding site. Nine (52.9%) patients developed thrombocytopenia. Six (35.3%) patients were discharged home or to a long-term acute care center;eleven (64.7%) patients died. The average length of stay was thirty-seven days. Conclusion: In our small case series, the rates of complications and mortality remained high while using bivalirudin as anticoagulation of choice in patients diagnosed with COVID-19 and treated with ECMO. Further studies are needed to investigate the optimal anticoagulant in this population.
ABSTRACT
Background: Passive immunization has a long history for infection prevention following exposure. We report results of a descriptive interim analysis from a study of an antibody “cocktail” of casirivimab with imdevimab (cas/imdev;formerly REGN-COV2) designed to bind non-competing epitopes of the viral spike protein, as a potential passive vaccine for the prevention of COVID-19 in people at risk of infection from household contact. Methods: In this ongoing Phase 3 study, asymptomatic participants exposed to a COVID-19-infected household member were randomized 1:1 to placebo or 1200 mg cas/imdev (600 mg of each antibody administered subcutaneously) within 96 hours of their household member testing positive. The analysis included participants who tested negative for SARS-CoV-2 by nasal, saliva, or nasopharyngeal swab and who were seronegative to SARS-CoV-2 antibodies at baseline. The proportion of participants who developed an RT-PCR-confirmed SARS-CoV-2 infection (asymptomatic or symptomatic) during the 1-month efficacy assessment period was summarized. Results: Initial results from the first evaluable 223 placebo and 186 cas/imdev participants who completed ≥29 days of the study are reported. Reduction in PCR-positive symptomatic disease was 100% (0/186 cas/imdev vs 8/223 placebo;OR 0.00 [CI 0.00, 0.69]). Reduction in any PCR-positive infection (symptomatic or asymptomatic) was 48% (10/186 vs 23/223;OR 0.49 [CI 0.20, 1.12]). Placebo-group participants had on average 100-fold higher peak viral load. In the cas/imdev group, viral RNA was not detected for longer than 1 week but was detected for 3-4 weeks in approximately 40% of placebo participants (Fig. 1). The proportions of infected participants with high viral loads (>10 4 copies/mL) were 13/21 placebo vs 0/9 cas/imdev. Total weeks of viral RNA detection and high viral load were 44 and 22 weeks in the placebo group vs 9 and 0 in the cas/imdev group. Total symptomatic weeks were 21 for placebo vs 0 for cas/imdev. A similar proportion of participants experienced at least 1 serious adverse event: placebo, 3/222 and cas/imdev, 1/186;none were deemed related to study treatment. Injection site reactions were similar: placebo, 1.4%;cas/ imdev, 2.6%. Conclusion: In this descriptive interim analysis of participants at risk of SARSCoV- 2 infection from household transmission, a subcutaneous dose of the cas/ imdev antibody cocktail prevented symptomatic infection, reduced overall infection, and decreased viral load and duration of viral RNA detection.