The Efficacy of Remdesivir Drug to Control the Recently Emerged Novel Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2): A Review Study

Introduction: Remdesivir is among the investigational drugs which show some promising effect against COVID-19, it may be due to its broad-spectrum antiviral action against some RNA viruses. To date very few clinical studies have been conducted on the use of remdesivir to the treatment of COVID-19. The main objective of the present study was, to conduct a review on the effect of Remdesivir to the treatment of COVID-19. To the best of our knowledge, this is the first systematic review on the effect of remdesivir drug to the treatment of COVID-19. Methodology: We have searched PubMed, for published studies on assessing the effect of remdesivir drug among patients with confirmed COVID-19. The main search terms used were “COVID-19” or “SARS-CoV-2”, “remdesivir”, and “systematic review”. Results: Only 11 research articles were found eligible for enclosure in this systematic review, among selected studies only two were randomized, placebo-controlled trial of intravenous remdesivir. Data on the efficacy of remdesivir in the patients with confirmed COVID-19 from clinical Phase-III trials are still pending. Recently, in the latter half of May month, results of two hospital based randomized, double-blind, placebo-controlled phase III trials studies were reported, both the studies found that remdesivir was efficient in the treatment of patients with confirmed COVID-19. However, Wang et al., (2020) found that remdesivir treatment was not significantly associated with clinical benefits. Conclusion: From the systematic review, the use of remdesivir to cure patients with confirms COVID-19 was found promising; however, further clinical studies with large patient size need to be considered. The efficacy and safety of remdesivir in the treatment of COVID-19 will require to be emphasized in future research studies.

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Thirty-Six-Month Amyloid Positron Emission Tomography Results Show Continued Reduction in Amyloid Burden with Subcutaneous Gantenerumab

Journal of Prevention of Alzheimer's Disease ◽

10.14283/jpad.2020.68 ◽

2020 ◽

pp. 1-4

Author(s):

G. Klein ◽

P. Delmar ◽

G.A. Kerchner ◽

C. Hofmann ◽

D. Abi-Saab ◽

...

Keyword(s):

Positron Emission Tomography ◽

Amyloid Plaque ◽

Emission Tomography ◽

Phase Iii ◽

Open Label ◽

Double Blind ◽

Positron Emission ◽

Open Label Extension ◽

Phase Iii Trials ◽

Clinical Benefits

Previous findings from the positron emission tomography (PET) substudy of the SCarlet RoAD and Marguerite RoAD open-label extension (OLE) showed gantenerumab doses up to 1200 mg every 4 weeks administered subcutaneously resulted in robust beta-amyloid (Aβ) plaque removal over 24 months in people with prodromal-to-moderate Alzheimer’s disease (AD). In this 36-month update, we demonstrate continued reduction, with mean (standard error) centiloid values at 36 months of -4.3 (7.5), 0.8 (6.7), and 4.7 (8.0) in the SCarlet RoAD (double-blind pooled placebo and active groups), Marguerite RoAD double-blind placebo, and Marguerite RoAD double-blind active groups respectively, representing a change of -57.0 (10.3), -90.3 (9.0), and -74.9 (10.5) centiloids respectively. These results demonstrate that prolonged gantenerumab treatment, at doses up to 1200 mg, reduces amyloid plaque levels below the amyloid positivity threshold. The ongoing GRADUATE Phase III trials will evaluate potential clinical benefits associated with gantenerumab-induced amyloid-lowering in people with early (prodromal-to-mild) AD.

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Heliox Therapy in Bronchiolitis: Phase III Multicenter Double-Blind Randomized Controlled Trial

PEDIATRICS ◽

10.1542/peds.2012-1317d ◽

2013 ◽

Vol 131 (4) ◽

pp. X4-X4

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Phase Iii ◽

Double Blind ◽

Randomized Controlled

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Interaction of neurovascular protection of erythropoietin with age, sepsis, and statin therapy following aneurysmal subarachnoid hemorrhage

Journal of Neurosurgery ◽

10.3171/2009.10.jns09954 ◽

2010 ◽

Vol 112 (6) ◽

pp. 1235-1239 ◽

Cited By ~ 14

Author(s):

Ming-Yuan Tseng ◽

Peter J. Hutchinson ◽

Peter J. Kirkpatrick

Keyword(s):

Subarachnoid Hemorrhage ◽

Statin Therapy ◽

Aneurysmal Subarachnoid Hemorrhage ◽

Controlled Trial ◽

Potential Interaction ◽

Repeated Measurements ◽

Unfavorable Outcome ◽

Phase Iii ◽

Neurovascular Protection ◽

Phase Iii Trials

Object In a previous randomized controlled trial, the authors demonstrated that acute erythropoietin (EPO) therapy reduced severe vasospasm and delayed ischemic deficits (DIDs) following aneurysmal subarachnoid hemorrhage. In this study, the authors aimed to investigate the potential interaction of neurovascular protection by EPO with age, sepsis, and concurrent statin therapy. Methods The clinical events of 80 adults older than 18 years and with < 72 hours of aneurysmal subarachnoid hemorrhage, who were randomized to receive 30,000 U of intravenous EPO-β or placebo every 48 hours for a total of 3 doses, were analyzed by stratification according to age (< or ≥ 60 years), sepsis, or concomitant statin therapy. End points in the trial included cerebral vasospasm and impaired autoregulation on transcranial Doppler ultrasonography, DIDs, and unfavorable outcome at discharge and at 6 months measured with the modified Rankin Scale and Glasgow Outcome Scale. Analyses were performed using the t-test and/or ANOVA for repeated measurements. Results Younger patients (< 60 years old) or those without sepsis obtained benefits from EPO by a reduction in vasospasm, impaired autoregulation, and unfavorable outcome at discharge. Compared with nonseptic patients taking EPO, those with sepsis taking EPO had a lower absolute reticulocyte count (nonsepsis vs sepsis, 143.5 vs. 105.8 × 109/L on Day 6; p = 0.01), suggesting sepsis impaired both hematopoiesis and neurovascular protection by EPO. In the EPO group, none of the statin users suffered DIDs (p = 0.078), implying statins may potentiate neuroprotection by EPO. Conclusions Erythropoietin-related neurovascular protection appears to be attenuated by old age and sepsis and enhanced by statins, an important finding for designing Phase III trials.

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Analysis of Gabapentin’s Efficacy in Tinnitus Treatment: A Systematic Review

Annals of Otology Rhinology & Laryngology ◽

10.1177/00034894211018921 ◽

2021 ◽

pp. 000348942110189

Author(s):

Matheus Pedrosa Tavares ◽

Fayez Bahmad

Keyword(s):

Systematic Review ◽

Controlled Trial ◽

Critical Evaluation ◽

Outcome Study ◽

Qualitative Synthesis ◽

Eligibility Criteria ◽

Double Blind ◽

Randomized Controlled ◽

Study Selection ◽

Tinnitus Treatment

Objectives: Tinnitus can be a chronic symptom that brings disability and distress. Some studies suggested that gabapentin might be effective on tinnitus relief. The objective of the study is to perform a systematic review in order to evaluate the efficacy of oral gabapentin in patients with tinnitus. Methods: A literature search was conducted in English and following the recommendations from PRISMA. The terms used were: (“tinnitus” OR “subjective tinnitus”) AND (“gabapentin”). The study selection was performed following the eligibility criteria in accordance to the PICOS (population, intervention, comparison, outcome, study design) strategy—patients with tinnitus; oral gabapentin; placebo; reduction of tinnitus severity questionnaires scores; prospective, double-blind, randomized controlled trial, respectively. The selected studies were included in qualitative synthesis. The studies were analyzed according to Joanna Briggs Institute’s critical appraisal checklist for randomized controlled trials. Results: One hundred twenty-one studies were found in 9 databases and 8 studies were found in gray literature. After study selection, 6 articles were read in full. Then, 2 studies were excluded and 4 were included in qualitative synthesis. All 4 articles were analyzed according to critical evaluation checklist. Conclusions: There is insufficient evidence to recommend the use of gabapentin for patients with tinnitus.

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Brivanib in Patients With Advanced Hepatocellular Carcinoma Who Were Intolerant to Sorafenib or for Whom Sorafenib Failed: Results From the Randomized Phase III BRISK-PS Study

Journal of Clinical Oncology ◽

10.1200/jco.2012.47.3009 ◽

2013 ◽

Vol 31 (28) ◽

pp. 3509-3516 ◽

Cited By ~ 359

Author(s):

Josep M. Llovet ◽

Thomas Decaens ◽

Jean-Luc Raoul ◽

Eveline Boucher ◽

Masatoshi Kudo ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Growth Factor ◽

Controlled Trial ◽

Objective Response ◽

Phase Iii ◽

Advanced Hepatocellular Carcinoma ◽

Time To Progression ◽

Fibroblast Growth Factor Receptors ◽

Double Blind ◽

Dual Inhibitor

Purpose Brivanib is a selective dual inhibitor of vascular endothelial growth factor and fibroblast growth factor receptors implicated in tumorigenesis and angiogenesis in hepatocellular carcinoma (HCC). An unmet medical need persists for patients with HCC whose tumors do not respond to sorafenib or who cannot tolerate it. This multicenter, double-blind, randomized, placebo-controlled trial assessed brivanib in patients with HCC who had been treated with sorafenib. Patients and Methods In all, 395 patients with advanced HCC who progressed on/after or were intolerant to sorafenib were randomly assigned (2:1) to receive brivanib 800 mg orally once per day plus best supportive care (BSC) or placebo plus BSC. The primary end point was overall survival (OS). Secondary end points included time to progression (TTP), objective response rate (ORR), and disease control rate based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) and safety. Results Median OS was 9.4 months for brivanib and 8.2 months for placebo (hazard ratio [HR], 0.89; 95.8% CI, 0.69 to 1.15; P = .3307). Adjusting treatment effect for baseline prognostic factors yielded an OS HR of 0.81 (95% CI, 0.63 to 1.04; P = .1044). Exploratory analyses showed a median time to progression of 4.2 months for brivanib and 2.7 months for placebo (HR, 0.56; 95% CI, 0.42 to 0.76; P < .001), and an mRECIST ORR of 10% for brivanib and 2% for placebo (odds ratio, 5.72). Study discontinuation due to treatment-related adverse events (AEs) occurred in 61 brivanib patients (23%) and nine placebo patients (7%). The most frequent treatment-related grade 3 to 4 AEs for brivanib included hypertension (17%), fatigue (13%), hyponatremia (11%), and decreased appetite (10%). Conclusion In patients with HCC who had been treated with sorafenib, brivanib did not significantly improve OS. The observed benefit in the secondary outcomes of TTP and ORR warrants further investigation.

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Patient‐Reported Outcomes and the Association With Clinical Response in Patients With Active Psoriatic Arthritis Treated With Golimumab: Findings Through 2 Years of a Phase III, Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

Arthritis Care & Research ◽

10.1002/acr.22044 ◽

2013 ◽

Vol 65 (10) ◽

pp. 1666-1673 ◽

Cited By ~ 16

Author(s):

Arthur Kavanaugh ◽

Iain B. McInnes ◽

Gerald G. Krueger ◽

Dafna Gladman ◽

Anna Beutler ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Clinical Response ◽

Patient Reported Outcomes ◽

Controlled Trial ◽

Phase Iii ◽

Double Blind ◽

Double Blind Placebo ◽

Patient Reported

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Melatonin for prevention of postoperative delirium after lower limb fracture surgery in elderly patients (DELIRLESS): study protocol for a multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2021-053908 ◽

2021 ◽

Vol 11 (12) ◽

pp. e053908

Author(s):

Stéphanie Sigaut ◽

Camille Couffignal ◽

Marina Esposito-Farèse ◽

Vincent Degos ◽

Serge Molliex ◽

...

Keyword(s):

Elderly Patients ◽

Lower Limb ◽

Postoperative Delirium ◽

Controlled Trial ◽

Functional Decline ◽

Assessment Method ◽

Phase Iii ◽

Double Blind ◽

Prolonged Length ◽

Surgery In Elderly

IntroductionPostoperative delirium (POD) is one of the most frequent complication after surgery in elderly patients, and is associated with increased morbidity and mortality, prolonged length of stay, cognitive and functional decline leading to loss of autonomy, and important additional healthcare costs. Perioperative inflammatory stress is a key element in POD genesis. Melatonin exhibits antioxidative and immune-modulatory proprieties that are promising concerning delirium prevention, but in perioperative context literature are scarce and conflicting. We hypothesise that perioperative melatonin can reduce the incidence of POD.Methods and analysisThe DELIRLESS trial is a prospective, national multicentric, phase III, superiority, comparative randomised (1:1) double-blind clinical trial. Among patients aged 70 or older, hospitalised and scheduled for surgery of a severe fracture of a lower limb, 718 will be randomly allocated to receive either melatonin 4 mg per os or placebo, every night from anaesthesiologist preoperative consultation and up to 5 days after surgery. The primary outcome is POD incidence measured by either the French validated translation of the Confusion Assessment Method (CAM) score for patients hospitalised in surgery, or CAM-ICU score for patients hospitalised in ICU (Intensive Care Unit). Daily delirium assessment will take place during 10 days after surgery, or until the end of hospital stay if it is shorter. POD cumulative incidence function will be compared at day 10 between the two randomised arms in a competing risks framework, using the Fine and Grey model with death as a competing risk of delirium.Ethics and disseminationThe DELIRLESS trial has been approved by an independent ethics committee the Comité de Protection des Personnes (CPP) Sud-Est (ref CPP2020-18-99 2019-003210-14) for all study centres. Participant recruitment begins in December 2020. Results will be published in international peer-reviewed medical journals.Trial registration numberNCT04335968, first posted 7 April 2020.Protocol version identifierN°3–0, 3 May 2021.

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