scholarly journals The Efficacy of Bamlanivimab in Reducing Emergency Department Visits and Hospitalizations in a Real-World Setting

2021 ◽  
Author(s):  
Douglas S Corwin ◽  
Peter T Ender ◽  
Nitasa Sahu ◽  
Ryan A Durgham ◽  
Dennis M McGorry ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibody ◽  
High Risk ◽  
Real World ◽  
Hospital Admissions ◽  
Emergency Department Visits ◽  
Spike Protein ◽  
Ambulatory Treatment ◽  
Real World Setting ◽  
Antibody Targeting

Abstract Bamlanivimab, a monoclonal antibody targeting the spike protein of SARS-CoV-2, is available for ambulatory treatment of COVID-19. This real-world study confirms the efficacy of bamlanivimab in reducing hospital admissions and emergency department visits among high-risk outpatients with mild to moderate COVID-19 illness and reveals a trend toward improved mortality.

scholarly journals Real-World Effectiveness and Tolerability of Monoclonal Antibodies for Ambulatory Patients with Early COVID-19

2021 ◽  
Author(s):  
Brandon J Webb ◽  
Whitney Buckel ◽  
Todd Vento ◽  
Allison M Butler ◽  
Nancy Grisel ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibodies ◽  
High Risk ◽  
Emergency Department Visit ◽  
Real World ◽  
Primary Outcome ◽  
Average Treatment Effect ◽  
Emergency Department Visits ◽  
Exploratory Analysis ◽  
Ambulatory Patients

Importance: Interventions to reduce hospitalization of patients with COVID-19 are urgently needed. Randomized trials for efficacy suggest that anti-SARS-CoV2 neutralizing monoclonal antibodies (MAb) may reduce medically-attended visits and hospitalization but effectiveness has not been confirmed in a real-world setting. Objective: Estimate the effectiveness of MAb infusion in a real-world cohort of ambulatory patients with early symptomatic COVID-19 at high risk for hospitalization. Design: Quasi-experimental observational cohort study using target trial emulation and causal inference methodology in pre-and post-implementation groups. Setting: Infusion centers and urgent care clinics within an integrated healthcare system in the United States Participants: 13,534 high-risk adult outpatients with symptomatic, laboratory-confirmed COVID-19 within 7 days of symptom onset. Exposures: A single intravenous infusion of either bamlanivimab 700 mg or casirivimab/imdevimab 1200 mg/1200 mg. Main Outcomes and Measures: The primary outcome was emergency department visit or hospitalization within 14 days of positive test. Patients who received MAb infusion were compared to contemporaneous controls using inverse probability of treatment weighting, and to a pre-implementation cohort using propensity-weighted interrupted time series analysis. An exploratory analysis compared effectiveness of casirivimab/imdevimab and bamlanivimab. Results: 7404 patients who would have been MAb-eligible were identified in a pre-implementation cohort (July 1-November 27, 2020). In the post-implementation period (November 28, 2020-January 28, 2021), 594 received MAb treatment and 5536 MAb-eligible patients did not. Among Mab recipients, 479 (80.6%) received bamlanivimab and 115 (19.4%) casirivimab/imdevimab. The primary outcome occurred in 75 (12.6%) MAb recipients, 1018 (18.4%) contemporaneous controls, and 1525 (20.6%) patients in the pre-implementation cohort. MAb treatment was associated with fewer subsequent emergency department visits and hospitalizations (odds ratio estimating the average treatment effect 0.69, 95% CI 0.60-0.79). After implementation, propensity-weighted probability of emergency department visit or hospitalization decreased by 0.7% per day (95% CI 0.03-0.10%, p<0.001). Overall, 7 (1.2%) MAb patients experienced an adverse event; two (0.3%) were considered serious. In the exploratory analysis, the effect of casirivimab/imdevimab versus bamlanivimab was not significant (OR 0.52, 95% CI 0.17-1.63, p=0.26). Conclusions and Relevance: MAb treatment of high-risk ambulatory patients with early COVID-19 was well-tolerated and effective at preventing the need for subsequent medically-attended care.

scholarly journals A randomized controlled trial of inhaled ciclesonide for outpatient treatment of symptomatic COVID-19 infections

2021 ◽  
Author(s):  
Brian M. Clemency ◽  
Renoj Varughese ◽  
Yaneicy Gonzalez-Rojas ◽  
Caryn G. Morse ◽  
Wanda Phipatanakul ◽  
...  
Keyword(s):  
Emergency Department ◽  
High Risk ◽  
Disease Progression ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Emergency Department Visits ◽  
Future Studies ◽  
Inhaled Steroids ◽  
Randomized Controlled

AbstractImportanceSystemic corticosteroids are commonly used in the treatment of severe COVID-19. However, their role in the treatment of patients with mild to moderate disease is less clear. The inhaled corticosteroid ciclesonide has shown early promise as a potential treatment for COVID-19.ObjectiveTo determine whether the inhaled steroid ciclesonide is efficacious in patients with high risk for disease progression and can reduce the incidence of long-term COVID-19 symptoms or post-acute sequelae of SARS-CoV-2.DesignThis was a phase III, multicenter, double-blind, randomized controlled trial to assess the safety and efficacy of ciclesonide metered-dose inhaler (MDI) for the treatment of non-hospitalized participants with symptomatic COVID-19 infection. Patients were screened from June 11, 2020 to November 3, 2020.SettingThe study was conducted at 10 centers throughout the U.S. public and private, academic and non-academic sites were represented among the centers.ParticipantsParticipants were randomly assigned to ciclesonide MDI 160 µg per actuation, two actuations twice a day (total daily dose 640 µg) or placebo for 30 days.Main Outcomes and MeasuresThe primary endpoint was time to alleviation of all COVID-19 related symptoms (cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell) by Day 30. Secondary endpoints included subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19.Results413 participants were screened and 400 (96.9%) were enrolled and randomized (197 in the ciclesonide arm and 203 in the placebo arm). The median time to alleviation of all COVID-19-related symptoms was 19.0 days (95% CI: 14.0, 21.0) in the ciclesonide arm and 19.0 days (95% CI: 16.0, 23.0) in the placebo arm. There was no difference in resolution of all symptoms by Day 30 (odds ratio [OR] 1.28, 95% CI: 0.84, 1.97). Participants treated with ciclesonide had fewer subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19 (OR 0.18, 95% CI: 0.04 - 0.85). No subjects died during the study.Conclusions and RelevanceCiclesonide did not achieve the primary efficacy endpoint of time to alleviation of all COVID-19-related symptoms. Future studies of inhaled steroids are needed to explore their efficacy in patients with high risk for disease progression and in reducing the incidence of long-term COVID-19 symptoms or post-acute sequelae of SARS-CoV-2.Trial RegistrationClinicalTrials.govNCT04377711https://clinicaltrials.gov/ct2/show/NCT04377711Key PointsQuestionCan the inhaled steroid ciclesonide be efficacious in patients with high risk for disease progression and reduce the incidence of long-term COVID-19 symptoms or post-acute sequelae of SARS-CoV-2?FindingsIn this randomized clinical trial of 413 patients, ciclesonide did not reduce the time to alleviation of all COVID-19-related symptoms. However, patients treated with ciclesonide had fewer subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19.MeaningFuture studies of inhaled steroids are needed to explore their efficacy in patients with high risk for disease progression and in reducing the incidence of long-term COVID-19 symptoms or post-acute sequelae of SARS-CoV-2.

scholarly journals 526. Implementation of Use of Monoclonal Antibody Therapy in a Large Academic Center for the Outpatient Treatment of Covid-19: Impact on 30 Day Hospitalization Rates, ED Visits and Death

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S364-S364
Author(s):  
Azra Bhimani ◽  
Vinay Srinivasan ◽  
Stacey Weinstein ◽  
Nathan Clemons ◽  
Quanna Batiste ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibody ◽  
Treatment Failure ◽  
Real World ◽  
Hospital Admissions ◽  
Antibody Therapy ◽  
Outpatient Setting ◽  
Hospitalized Patients ◽  
Monoclonal Antibody Therapy ◽  
Ed Visits

Abstract Background Monoclonal Antibody Therapy (MAbs) has been shown to reduce rates of ED visits and hospitalizations in patients at risk for severe Covid-19 infection in clinical trials. Since November, three Mabs received emergency use authorization: Bamlanivimab (Bam), Bamlanivimab/Etesevimab (Bam/Ete) and Casirivimab/Imdevimab (Casi/imdevi). We describe here the real-world effectiveness of implementing early MAb therapy in the outpatient setting for individuals with Covid-19 at high risk of progression. Methods We examined the records of 808 UCLA Health patients with a confirmed positive SARS-CoV2 PCR test who were either referred for outpatient Mab therapy or received Mab treatment in the emergency department (ED) between December 10, 2020, and May 3, 2021. The primary outcome of our analysis was the combined 30-day incidence of emergency department visits, hospitalizations, or death following the date of referral. SARS-CoV2 isolates of hospitalized patients who had received Mabs were sequenced to determine the presence of variants. Results Of 808 patients, 383 were referred for treatment but did not receive treatment, 109 received Mabs in the ED and 316 patients were treated in an outpatient setting. Composite 30-day mortality, ED visits and hospital admissions were significantly reduced in the combination therapy group (Bam/Ete or Cas/Imd) compared with monotherapy (Bam alone) or no treatment groups (aHR 0.16, 95% CI .038, .67). Significant factors associated with the composite outcome included: history of lung disease (HR 4.46, 95% CI 2.89-6.90), cardiovascular disease (HR 1.87, 95% CI 1.12-3.12), kidney disease (HR 2.04, 95% CI 1.27-3.25), and immunocompromised state (HR 3.24, 95% CI 1.02-10.26) as well as high social vulnerability index (HR 1.87, 95% CI 1.13-3.10). Over one-third of hospitalized patients who had received Mabs were confirmed to have the California variant (B.1.427/29) (Figure 1). Figure 1. Covid-19 MAB Treatment Failure Lineages Conclusion Our data show that in a real-world setting, combination monoclonal antibody therapy, not monotherapy, significantly reduced ED visits and hospital admissions, likely due to the presence of the California variants. High socioeconomic vulnerability and certain medical conditions increased risk of treatment failure. Disclosures Omai Garner, PhD, D(ABMM), Beckman Coulter (Scientific Research Study Investigator)

Risk factors of hospital admissions and recurrent emergency department visits among pediatric asthma patients

2020 ◽  
pp. 1011-1015
Author(s):  
Abdullah Aldamigh ◽  
Afaf Alnefisah ◽  
Abdulrahman Almutairi ◽  
Fatima Alturki ◽  
Suhailah Alhtlany ◽  
...  
Keyword(s):  
Risk Factors ◽  
Emergency Department ◽  
Hospital Admissions ◽  
Pediatric Asthma ◽  
Emergency Department Visits ◽  
Asthma Patients

scholarly journals Program of Integrated Care for Patients with Chronic Obstructive Pulmonary Disease and Multiple Comorbidities (PIC COPD+): a randomised controlled trial

2018 ◽  
Vol 51 (1) ◽  
pp. 1701567 ◽  
Author(s):  
Louise Rose ◽  
Laura Istanboulian ◽  
Lise Carriere ◽  
Anna Thomas ◽  
Han-Byul Lee ◽  
...  
Keyword(s):  
Emergency Department ◽  
Hospital Admissions ◽  
Controlled Trial ◽  
Case Manager ◽  
Emergency Department Visits ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Component Case

We sought to evaluate the effectiveness of a multi-component, case manager-led exacerbation prevention/management model for reducing emergency department visits. Secondary outcomes included hospitalisation, mortality, health-related quality of life, chronic obstructive pulmonary disease (COPD) severity, COPD self-efficacy, anxiety and depression.Two-centre randomised controlled trial recruiting patients with ≥2 prognostically important COPD-associated comorbidities. We compared our multi-component intervention including individualised care/action plans and telephone consults (12-weekly then 9-monthly) with usual care (both groups). We used zero-inflated Poisson models to examine emergency department visits and hospitalisation; Cox proportional hazard model for mortality.We randomised 470 participants (236 intervention, 234 control). There were no differences in number of emergency department visits or hospital admissions between groups. We detected difference in emergency department visit risk, for those that visited the emergency department, favouring the intervention (RR 0.74, 95% CI 0.63–0.86). Similarly, risk of hospital admission was lower in the intervention group for those requiring hospital admission (RR 0.69, 95% CI 0.54–0.88). Fewer intervention patients died (21 versus 36) (HR 0.56, 95% CI 0.32–0.95). No differences were detected in other secondary outcomes.Our multi-component, case manager-led exacerbation prevention/management model resulted in no difference in emergency department visits, hospital admissions and other secondary outcomes. Estimated risk of death (intervention) was nearly half that of the control.

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