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.

2021 Mark Coventry Award: Use of a smartphone-based care platform after primary partial and total knee arthroplasty: a prospective randomized controlled trial

2021 ◽  
Vol 103-B (6 Supple A) ◽  
pp. 3-12 ◽  
Author(s):  
David A. Crawford ◽  
Paul J. Duwelius ◽  
Michael A. Sneller ◽  
Michael J. Morris ◽  
Jason M. Hurst ◽  
...  
Keyword(s):  
Emergency Department ◽  
Treatment Group ◽  
Knee Arthroplasty ◽  
Care Management ◽  
Controlled Trial ◽  
Emergency Department Visits ◽  
Control Group ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Total Knee

Aims The purpose is to determine the non-inferiority of a smartphone-based exercise educational care management system after primary knee arthroplasty compared with a traditional in-person physiotherapy rehabilitation model. Methods A multicentre prospective randomized controlled trial was conducted evaluating the use of a smartphone-based care management system for primary total knee arthroplasty (TKA) and partial knee arthroplasty (PKA). Patients in the control group (n = 244) received the respective institution’s standard of care with formal physiotherapy. The treatment group (n = 208) were provided a smartwatch and smartphone application. Early outcomes assessed included 90-day knee range of movement, EuroQoL five-dimension five-level score, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) score, 30-day single leg stance (SLS) time, Time up and Go (TUG) time, and need for manipulation under anaesthesia (MUA). Results Overall, 90-day mean flexion was not significantly different between the control (121° (SD 11.7°)) and treatment groups (121o; p = 0.559); 90-day mean SLS was 22.7 seconds (SD 9.8) in controls and 24.3 seconds (SD 20.8) in treatment (p = 0.519); 90-day mean TUG times were 10.1 seconds (SD 4.8) in control and 9.3 seconds (SD 3.3) in treatment (p = 0.139). Mean KOOS JR scores were significantly different between control group (73.6 (SD 13.4)) and treatment group (70.4 (SD 12.6); p = 0.026). MUAs were performed in nine (3.7%) patients in the control group and four (1.9%) in the treatment group (p = 0.398). Physiotherapy was performed by 230 (94.4%) of control group and 123 (59.3%) of treatment group (p < 0.001). There were no significant differences between groups in postoperative urgent care visits, or readmissions within 90 days, with significantly fewer emergency department visits in the treatment group (16 (8.2%) vs five (2.5%), p = 0.014). Conclusion The use of the smartwatch/smartphone care platform demonstrated non-inferiority of clinically significant outcomes to traditional care models, while requiring significantly less postoperative physiotherapy and fewer emergency department visits. This platform could aid in decreasing postoperative costs, while improving patient engagement and communication with the healthcare team. Cite this article: Bone Joint J 2021;103-B(6 Supple A):3–12.

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.

A pragmatic randomized controlled trial of a cardiac hospital-to-home transitional care program in a Singapore academic medical center

2020 ◽  
Vol 25 (2) ◽  
pp. 55-66
Author(s):  
Yanying Chen ◽  
Yi Jin Tan ◽  
Ya Sun ◽  
Cheng Zhan Chua ◽  
Jeffrey Kwang Sui Yoo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Emergency Department ◽  
Transitional Care ◽  
Controlled Trial ◽  
Care Program ◽  
Emergency Department Visits ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Hospital To Home

Background Rehospitalizations are common in healthcare. They are costly for hospitals and patients and a substantial percentage are preventable, partly because hospital-to-community transitions are often unmanaged or poorly managed. In this study, we conducted a pragmatic randomized, controlled trial to evaluate the effectiveness of a new nurse–practitioner-led transitional care program called CareHub, piloted in Singapore’s National University Hospital. Methods Study population included all eligible cardiac patients admitted between July 2016 and November 2016. Patients were followed for six months post-discharge. Primary outcomes other than emergency department visits were all cardiac-related: number of readmissions, specialist visits, emergency department visits, and total days readmitted. Secondary outcomes: variables related to quality of life and transitional care. Regression analyses were used to estimate the intent-to-treat effect of CareHub and explore treatment heterogeneity. Results CareHub reduced the mean number of unplanned readmissions by 0.23 (a 39% reduction relative to control mean of 0.60 unplanned readmissions, p < 0.05), mean number of all readmissions by 0.20 (31% reduction relative to control mean of 0.63 readmissions, p = 0.10), mean number of total unplanned days in hospital by 2.2 (56% reduction relative to control mean of 4.0 days, p < 0.05), mean number of total days in hospital by 2.0 (42% reduction relative to control mean of 4.3 days, p < 0.10). Treatment effects varied by pre-admission health and socio-economic status. Conclusion A carefully designed protocolized cardiac hospital-to-home transition program can reduce resource utilization while improving quality of life.

Cost-effectiveness of a brief two-stage emergency department intervention for high-risk elders: results of a quasi-randomized controlled trial

2003 ◽  
Vol 41 (1) ◽  
pp. 45-56 ◽  
Author(s):  
Jane McCusker ◽  
Philip Jacobs ◽  
Nandini Dendukuri ◽  
Eric Latimer ◽  
Pierre Tousignant ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Cost Effectiveness ◽  
High Risk ◽  
Controlled Trial ◽  
Two Stage ◽  
Randomized Controlled

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.

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