scholarly journals Remdesivir Efficacy in COVID-19 Treatment: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Sherief Abd-Elsalam ◽  
Ossama Ashraf Ahmed ◽  
Noha O. Mansour ◽  
Doaa H. Abdelaziz ◽  
Marwa Salama ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Mortality Rate ◽  
Hospital Stay ◽  
Standard Care ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Final Analysis ◽  
Secondary Outcome ◽  
Control Group ◽  
Egyptian Patients

To date, no antiviral therapy has shown proven clinical effectiveness in treating patients with COVID-19. We assessed the efficacy of remdesivir in hospitalized Egyptian patients with COVID-19. Patients were randomly assigned at a 1:1 ratio to receive either remdesivir (200 mg on the first day followed by 100 mg daily for the next 9 days intravenously infused over 30–60 minutes) in addition to standard care or standard care alone. The primary outcomes were the length of hospital stay and mortality rate. The need for mechanical ventilation was assessed as a secondary outcome. Two hundred patients (100 in each group) completed the study and were included in the final analysis. The remdesivir group showed a significantly lower median duration of hospital stay (10 days) than the control group (16 days; P < 0.001). Eleven of the patients in the remdesivir group needed mechanical ventilation compared with eight patients in the control group (P = 0.469). The mortality rate was comparable between the two groups (P = 0.602). Mortality was significantly associated with older age, elevated C-reactive protein levels, elevated D-dimer, and the need for mechanical ventilation (P = 0.039, 0.003, 0.001, and < 0.001 respectively). Remdesivir had a positive influence on length of hospital stay, but it had no mortality benefit in Egyptian patients with COVID-19. Its use, in addition to standard care including dexamethasone, should be considered, particularly in low- and middle-income countries when other effective options are scarce.

scholarly journals Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial

2020 ◽  
Vol 75 (11) ◽  
pp. 3373-3378 ◽  
Author(s):  
Hamideh Abbaspour Kasgari ◽  
Siavash Moradi ◽  
Amir Mohammad Shabani ◽  
Farhang Babamahmoodi ◽  
Ali Reza Davoudi Badabi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Stay ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Control Group ◽  
Single Centre ◽  
Mazandaran Province ◽  
Randomized Controlled

Abstract Background New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19. Methods This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1. Results Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray’s P = 0.033). Conclusions This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.

scholarly journals MO850OUTCOMES OF COVID-19 INFECTION IN DIALYSIS PATIENTS IN QATAR: A NATIONWIDE COHORT STUDY

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Tarek Abdellatif ◽  
Abdullah Hamad ◽  
Mohamad Alkadi ◽  
Essa Abuhelaiqa ◽  
Muftah Othman ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mechanical Ventilation ◽  
Critical Care ◽  
Mortality Rate ◽  
General Population ◽  
Hospital Stay ◽  
Laboratory Tests ◽  
Length Of Hospital Stay ◽  
Dialysis Patients ◽  
Risk Of Death

Abstract Background and Aims Patients on maintenance dialysis are more susceptible to COVID-19 and its severe complications. We studied outcomes of COVID-19 infection in dialysis patients in the state of Qatar. Our primary outcome was to determine the mortality rate of dialysis patients with COVID-19 infection and associated risk factors. Our secondary outcomes were to assess the severity of COVID-19 in dialysis patients and its related complications such as the incidence of hypoxia, critical care unit admission, need for mechanical ventilation or inotropes, incidence of acute respiratory distress syndrome (ARDS), and length of hospital stay. Method This was an observational, analytical, retrospective, nationwide study. We included all adult patients on dialysis who tested positive for COVID-19 (PCR assay of nasopharyngeal swab) during the period from February 1, 2020 to July 19, 2020. Patient demographics and clinical features were collected from a national electronic medical record. Laboratory tests were evaluated upon diagnosis and on day 7. Results There were 76 out of 1068 dialysis patients who were diagnosed with COVID-19 (age 56±13.6, 56 hemodialysis and 20 peritoneal dialysis, 56 males). Eleven patients (15%) died during study period. Mortality due to COVID-19 among our dialysis cohort was 100 times higher than that in the general population for the same period (15% vs. 0.15%; OR 114.2 [95% CI: 1.53 to 2.44]; p&lt;0.001). Univariate analysis for risk factors associated with COVID-19-related death in dialysis patients showed minor but statistically significant increases in risks with age (OR 1.07), peak WBC peak level (OR 1.189), AST level at day 7 (OR 1.04), fibrinogen level at day 7 (OR 1.4), D-dimer level on day 7 (OR 1.94), and peak CRP level (OR 1.01). A major increase in the risk of death was noted with atrial fibrillation (OR, 8.7; p=0.008) and hypoxia (OR: 28; p=0.001). High severity of COVID-19 illness in dialysis manifested as 25% of patients required admission to the intensive care unit, 18.4% had ARDS, 17.1% required mechanical ventilation, and 14.5% required inotropes for intractable hypotension or shock. The mean length of hospital stay was 19.2±10.4 days. Laboratory tests were remarkable for severely elevated ferritin, fibrinogen, CRP, and peak IL-6 levels and decreased albumin levels on day 7. Conclusion This is the first study to be conducted at a national level in Qatar exploring COVID-19 in a dialysis population. Dialysis patients had a high mortality rate of COVID-19 infection compared to the general population. Dialysis patients had severe COVID-19 course complicated by prolonged hospitalization and high need for critical care, mechanical ventilation and inotropes. Special care should be done to prevent COVID-19 in dialysis patients to avoid severe complications and mortality.

scholarly journals Trends in the Incidence and Outcome of Sepsis Using Data from a Japanese Nationwide Medical Claims Database -the Japan Sepsis Alliance (JaSA) Study Group-

2021 ◽  
Author(s):  
Taro Imaeda ◽  
Taka-aki Nakada ◽  
Nozomi Takahashi ◽  
Yasuo Yamao ◽  
Satoshi Nakagawa ◽  
...  
Keyword(s):  
Mortality Rate ◽  
Hospital Mortality ◽  
Hospital Stay ◽  
Organ Dysfunction ◽  
Length Of Hospital Stay ◽  
Annual Incidence ◽  
Secondary Outcome ◽  
Claim Database ◽  
Electronic Health Record Data ◽  
Acute Organ Dysfunction

Abstract Background: Trends in the incidence and outcomes of sepsis using a Japanese nationwide database were investigated.Methods: This was a retrospective cohort study. Adult patients, who had both presumed serious infections and acute organ dysfunction, between 2010 and 2017 were extracted using a combined method of administrative and electronic health record data from the Japanese nationwide medical claim database, which covered 71.5% of all acute care hospitals in 2017. Presumed serious infection was defined using blood culture test records and antibiotic administration. Acute organ dysfunction was defined using records of diagnosis according to the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, and records of organ support. The primary outcome variables were the annual incidence of sepsis and death in sepsis per 1,000 inpatients. The secondary outcome variables were in-hospital mortality rate and length of hospital stay in patients with sepsis. Results: The analyzed dataset included 50,490,128 adult inpatients admitted between 2010 and 2017. Of these, 2,043,073 (4.0%) patients had sepsis. During the 8-year period, the annual proportion of patients with sepsis significantly increased (slope=+0.30%/year, P<0.0001), accounting for 4.9% of the total inpatients in 2017. The annual death rate of sepsis per 1,000 inpatients significantly increased (slope=+1.8/1,000 inpatients year, P=0.0001), accounting for 8.4 deaths per 1,000 inpatients in 2017. The in-hospital mortality rate and mean length of hospital stay significantly decreased (P<0.001) over the study period and were 18.3% and 41.9 days in 2017, respectively.Conclusions: The Japanese nationwide data indicate that the annual incidence of sepsis and death in inpatients with sepsis significantly increased; however, the annual mortality rates and length of hospital stay in patients with sepsis significantly decreased. The increasing incidence of sepsis and death in sepsis appear to be a significant and ongoing issue.

scholarly journals Dexmedetomidine use and Mortality in Mechanically-Ventilated Patients with Severe Burns: A Cohort Study Using a National Inpatient Database in Japan

2020 ◽  
Author(s):  
Yuki Enomoto ◽  
Masao Iwagami ◽  
Asuka Tsuchiya ◽  
Kojiro Morita ◽  
Toshikazu Abe ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Control Group ◽  
Mechanically Ventilated ◽  
Mechanically Ventilated Patients ◽  
Severe Burns ◽  
And Control ◽  
Inpatient Database ◽  
Ventilated Patients

Abstract Background: Dexmedetomidine is an alpha 2-adrenergic receptor agonist. Apart from its sedative effects, dexmedetomidine has the potential to reduce mortality through its anti-inflammatory effect. However, the impact of dexmedetomidine on in-hospital outcomes of patients with severe burns remains unclear. Therefore, we aimed to elucidate the association between dexmedetomidine and mortality in mechanically-ventilated patients with severe burns, using a Japanese nationwide database of in-hospital patients.Methods: We included adults with severe burns (burn index ≥ 10) who were registered in the Japanese Diagnosis Procedure Combination national inpatient database from 2010 to 2018, started mechanical ventilation within 3 days of admission, and received any sedative drug (dexmedetomidine, midazolam, or propofol). One-to-one propensity score matching was performed between patients who received dexmedetomidine on the day of mechanical ventilation initiation (dexmedetomidine group) and those who did not receive dexmedetomidine (control group). The primary outcome was all-cause 30-day in-hospital mortality. Secondary outcomes were length of hospital stay and duration of mechanical ventilation in all patients and survivors.Results: Eligible patients (n = 1,888) were classified into the dexmedetomidine group (n = 371) or the control group (n = 1,517). After one-to-one propensity score matching, we compared 329 patients from each of the two groups. No significant difference was observed in 30-day mortality between patients in the dexmedetomidine and control groups (22.8% vs. 22.5%, respectively; odds ratio, 1.02; 95% confidence interval, 0.71-1.46). Moreover, there were no significant differences between patients in the dexmedetomidine and control groups in terms of the length of hospital stay or the duration of mechanical ventilation.Conclusions: We found no significant association between dexmedetomidine use and in-hospital outcomes (mortality, length of hospital stay, and length of mechanical ventilation) in mechanically-ventilated patients with severe burns. Dexmedetomidine use may not improve the above-mentioned outcomes; therefore, its selection should be based on the patient’s general condition and the target level of sedation.

scholarly journals Clinical Pathways Based on Integrative Medicine in Chinese Hospitals Improve Treatment Outcomes for Patients with Acute Myocardial Infarction: A Multicentre, Nonrandomized Historically Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Lei Wang ◽  
Minzhou Zhang ◽  
Liheng Guo ◽  
Jianyong Qi ◽  
Haiming Luo ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Hospital Stay ◽  
Integrative Medicine ◽  
Clinical Pathways ◽  
Controlled Trial ◽  
Length Of Hospital Stay ◽  
Control Group ◽  
Hospitalization Period ◽  
The Impact

Objective. To determine the impact of an integrative medicine clinical pathways (CPs) on the length of in-hospital stay and on outcomes for patients with acute myocardial infarction (AMI).Methods. A multicenter nonrandomized controlled trial enrolling 197 consecutive patients with AMI at eight urban TCM hospitals was conducted between 1 January 2010 and 31 October 2010. These patients were enrolled in the interventional group after the CPs had been implemented. The control group included 405 patients with AMI from eight hospitals; these patients were treated between 1 January 2008 and 31 December 2009, before the CPs were implemented. Outcome measures were the length of hospital stay costs of medical care, and major cardiovascular events (MACEs) during hospitalization.Results. Compared with the control group, the patients in intervention group had a shorter length of hospital stay (9.2±4.2days versus12.7±8.6days,P<0.05), and reduced healthcare costs in hospital (46365.7±18266.9versus52866.0±35404.4,P<0.05). There were statistically significant differences in MACE between the two groups during the hospitalization period (2.5% versus 6.9%,P=0.03).Conclusion. These data suggest that the development and implementation of the clinical pathways based in Integrative Medicine could further improve quality of care and outcome for patients with AMI.

scholarly journals Clinical Efficacy of Hydroxychloroquine in Patients with COVID-19: Findings from an Observational Comparative Study in Saudi Arabia

Antibiotics ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. 365
Author(s):  
Saleh Alghamdi ◽  
Bassant Barakat ◽  
Ilhem Berrou ◽  
Abdulhakim Alzahrani ◽  
Abdul Haseeb ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Saudi Arabia ◽  
Hospital Stay ◽  
Tertiary Care ◽  
Length Of Hospital Stay ◽  
Clinical Effectiveness ◽  
Treated Group ◽  
Control Group ◽  
Care Hospital ◽  
Hospital Data

The aim of this study was to assess the clinical effectiveness of Hydroxychloroquine-based regimens versus standard treatment in patients with the coronavirus disease admitted in 2019 to a hospital in Saudi Arabia. A comparative observational study, using routine hospital data, was carried out in a large tertiary care hospital in Al Baha, Saudi Arabia, providing care to patients with COVID-19 between April 2019 and August 2019. Patients were categorized into two groups: the Hydroxychloroquine (HCQ) group, treated with HCQ in a dose of 400 mg twice daily on the first day, followed by 200 mg twice daily; the non HCQ group, treated with other antiviral or antibacterial treatments according to protocols recommended by the Ministry of Health (MOH) at the time. The primary outcomes were the length of hospital stay, need for admission to the intensive care unit (ICU), time in ICU, and need for mechanical ventilation. Overall survival was also assessed. 568 patients who received HCQ (treatment group) were compared with 207 patients who did not receive HCQ (control group). HCQ did not improve mortality in the treated group (7.7% vs. 7.2%). There were no significant differences in terms of duration of hospitalization, need for and time in ICU, and need for mechanical ventilation among the groups. Our study provides further evidence that HCQ treatment does not reduce mortality rates, length of hospital stay, admission and time in ICU, and need for mechanical ventilation in patients hospitalized with COVID-19.

scholarly journals Timing of Tracheostomy and Outcomes in Adults with Moderate and Severe Tetanus

2019 ◽  
Vol 34 (2) ◽  
pp. 20-23
Author(s):  
Wenrol Espinosa ◽  
Von Vinco
Keyword(s):  
Mechanical Ventilation ◽  
Mortality Rate ◽  
Hospital Stay ◽  
Length Of Hospital Stay ◽  
Morbidity And Mortality ◽  
P Value ◽  
Early Tracheostomy ◽  
Severe Stage ◽  
Significant Difference ◽  
Severe Tetanus

Objective: This study aimed to evaluate the timing of tracheostomy and relationship to outcomes (length of hospital stay, length of mechanical ventilation, morbidity and mortality rate) in adults with moderate and severe tetanus.  Methods:             Design:           Cross-Sectional Study             Setting:           Tertiary Government Training Hospital             Patients:         All adult patients (19 years old and above) diagnosed with moderate and    severe stage tetanus from January 2015 to January 2018 were considered for inclusion. Results: There were 109 patients included in this study, majority were males (n=95) with a male to female ratio of 7:1. Most belonged to the 51-60 years age group (mean: 53.7 SD: +/-16.1). Based on Cole Tetanus staging, the majority presented with severe stage tetanus (67.9%; n=74). Only 35.8% (n=39) were admitted at the Intensive Care Unit. Early tracheostomy was performed in 56.0% (n=61) of the patients (mean 6.3 hours SD: +/- 4.61). Mortality rate was noted to be 52.3% (n=57). Overall, early tracheostomy among moderate to severe stage tetanus patients showed shorter length of hospital stay and length of mechanical ventilation than  late tracheostomy (tracheostomy >24 hours) (p-value < .05). However, no significant difference was noted for timing of tracheostomy in terms of morbidity and mortality rate (p-value > .05). Conclusion: Early tracheostomy within less than 24 hours from time of admission for moderate and severe tetanus is associated with shorter length of hospital stay and mechanical ventilation than late tracheostomy, and may play a role in tetanus management. Keywords: tracheostomy; tetanus; hospital stay; mechanical ventilation; morbidity; mortality

scholarly journals Neurofeedback Training versus Treatment-as-Usual for Alcohol Dependence: Results of an Early-Phase Randomized Controlled Trial and Neuroimaging Correlates

2021 ◽  
pp. 1-14
Author(s):  
Leena Subramanian ◽  
Leon Skottnik ◽  
W. Miles Cox ◽  
Michael Lührs ◽  
Rachel McNamara ◽  
...  
Keyword(s):  
Treatment Group ◽  
Alcohol Dependence ◽  
Outcome Measures ◽  
Standard Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Salience Network ◽  
Neurofeedback Training

Introduction: Alcohol dependence is one of the most common substance use disorders, and novel treatment options are urgently needed. Neurofeedback training (NFT) based on real-time functional magnetic resonance imaging (rtf­MRI) has emerged as an attractive candidate for add-on treatments in psychiatry, but its use in alcohol dependence has not been formally investigated in a clinical trial. We investigated the use of rtfMRI-based NFT to prevent relapse in alcohol dependence. Methods: Fifty-two alcohol-dependent patients from the UK who had completed a detoxification program were randomly assigned to a treatment group (receiving rtfMRI NFT in addition to standard care) or the control group (receiving standard care only). At baseline, alcohol consumption was assessed as the primary outcome measure and a variety of psychological, behavioral, and neural parameters as secondary outcome measures to determine feasibility and secondary training effects. Participants in the treatment group underwent 6 NFT sessions over 4 months and were trained to downregulate their brain activation in the salience network in the presence of alcohol stimuli and to upregulate frontal activation in response to pictures related to positive goals. Four, 8, and 12 months after baseline assessment, both groups were followed up with a battery of clinical and psychometric tests. Results: Primary outcome measures showed very low relapse rates for both groups. Analysis of neural secondary outcome measures indicated that the majority of patients modulated the salience system in the desired directions, by decreasing activity in response to alcohol stimuli and increasing activation in response to positive goals. The intervention had a good safety and acceptability profile. Conclusion: We demonstrated that rtfMRI-neurofeedback targeting hyperactivity of the salience network in response to alcohol cues is feasible in currently abstinent patients with alcohol dependence.

scholarly journals Breastfeeding success with the use of the inverted syringe technique for management of inverted nipples in lactating women: a study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Mona Nabulsi ◽  
Rayan Ghanem ◽  
Marlie Abou-Jaoude ◽  
Ali Khalil
Keyword(s):  
Randomized Controlled Trial ◽  
Exclusive Breastfeeding ◽  
Standard Care ◽  
Infant Nutrition ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Inverted Nipples

Abstract Background Breastfeeding provides ideal infant nutrition, conferring several health benefits to children and their mothers. Women with inverted nipples, however, face difficulties that force them to prematurely terminate breastfeeding. Whereas available conservative measures for the correction of inverted nipples are of limited success, the use of an inverted syringe may be effective in achieving high rates of infant latching and exclusive breastfeeding. This technique, however, has not been investigated in a clinical trial. Methods/design This open-label randomized controlled trial aims to investigate whether, in women with inverted nipples, the use of an inverted syringe increases the rate of exclusive breastfeeding at one month compared to standard care. One-hundred healthy women with grade 1 or 2 inverted nipples will be recruited as of 37 weeks of gestation. They will be randomly allocated to standard care (control group) or to an intervention group. The intervention consists of using an inverted syringe to evert the nipple before every breastfeed, starting with the first feed after delivery. The primary outcome measure is the rate of exclusive breastfeeding at 1 month. Secondary outcome measures include exclusive breastfeeding rates at 3 and 6 months, nipple eversion rate, successful latching rate, rates of any breastfeeding at 1, 3, and 6 months, breastfeeding-associated complications, maternal satisfaction with breastfeeding, maternal quality of life, and adverse events. Descriptive and regression analysis will be conducted under the intention to treat basis. Discussion The use of the inverted syringe to evert inverted nipples is a simple, inexpensive, and safe technique that can be performed by mothers with inverted nipples. Findings of this trial, if positive, will provide much needed evidence for a safe, affordable, readily available, and simple intervention to treat inverted nipples, and improve breastfeeding practice among affected women. Trial registration ClinicalTrials.gov, NCT03529630. Registered May 8, 2018.

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