scholarly journals Treating COVID-19 With Hydroxychloroquine (TEACH): A Multicenter, Double-Blind Randomized Controlled Trial in Hospitalized Patients

2020 ◽  
Vol 7 (10) ◽  
Author(s):  
Robert J Ulrich ◽  
Andrea B Troxel ◽  
Ellie Carmody ◽  
Jaishvi Eapen ◽  
Martin Bäcker ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Disease Progression ◽  
Severe Disease ◽  
Small Sample ◽  
Hospitalized Patients ◽  
Controlled Trials ◽  
Double Blind ◽  
Randomized Controlled ◽  
End Point ◽  
Clinical Scores

Abstract Background Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19. Methods We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14. Results A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance (P = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay. Conclusions In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.

scholarly journals Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 151
Author(s):  
Raphael A. Yaakov ◽  
Özgür Güler ◽  
Tim Mayhugh ◽  
Thomas E. Serena
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Regulatory Compliance ◽  
Small Sample ◽  
Controlled Trials ◽  
Holistic View ◽  
Health Crisis ◽  
Randomized Controlled ◽  
Healthcare Needs

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

scholarly journals Vitamin D supplementation, COVID-19 and disease severity: a meta-analysis

QJM ◽  
2021 ◽  
Author(s):  
K Shah ◽  
D Saxena ◽  
D Mavalankar
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trials ◽  
Usual Care ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Vitamin D Supplementation ◽  
Hospitalized Patients ◽  
Controlled Trials ◽  
Randomized Controlled

Abstract Objective: Current meta-analysis aims to understand the effect of oral supplementation of vitamin D on intensive care unit (ICU) requirement and mortality in hospitalized COVID-19 patients. Methods: Databases PubMed, preprint servers, and google scholar were searched from December 2019 to December 2020. Authors searched for the articles assessing role of vitamin D supplementation on COVID-19. Cochrane RevMan tool was used for quantitative assessment of the data, where heterogeneity was assessed using I2 and Q statistics and data was expressed using odds ratio with 95% confidence interval. Results: Final meta-analysis involved pooled data of 532 hospitalized patients (189 on vitamin D supplementation and 343 on usual care/placebo) of COVID-19 from three studies (Two randomized controlled trials, one retrospective case-control study). Statistically (p<0.0001) lower ICU requirement was observed in patients with vitamin D supplementation as compared to patients without supplementations (odds ratio: 0.36; 95% CI: 0.210-0.626). However, it suffered from significant heterogeneity, which reduced after sensitivity analysis. In case of mortality, vitamin D supplements has comparable findings with placebo treatment/usual care (odds ratio: 0.93; 95% CI: 0.413-2.113; p=0.87). The studies did not show any publication bias and had fair quality score. Subgroup analysis could not be performed due to limited number of studies and hence dose and duration dependent effect of vitamin D could not be evaluated. Conclusions: Although the current meta-analysis findings indicate potential role of vitamin D in improving COVID-19 severity in hospitalized patients, more robust data from randomized controlled trials are needed to substantiate its effects on mortality.

scholarly journals MANAGEMENT OF ENDOCRINE DISEASE: Effects of telecare intervention on glycemic control in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials

2015 ◽  
Vol 172 (3) ◽  
pp. R93-R101 ◽  
Author(s):  
Zhenru Huang ◽  
Hong Tao ◽  
Qingdong Meng ◽  
Long Jing
Keyword(s):  
Type 2 Diabetes ◽  
Glycemic Control ◽  
Randomized Controlled Trials ◽  
Sample Size ◽  
Plasma Glucose ◽  
Small Sample ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled

ObjectiveTo review the published literature on the effects of telecare intervention in patients with type 2 diabetes and inadequate glycemic control.Design and methodsA review of randomized controlled trials on telecare intervention in patients with type 2 diabetes, and a search of electronic databases such as The Cochrane Library, PubMed, EBSCO, CINAHL, Science Direct, Journal of Telemedicine and Telecare, and China National Knowledge Infrastructure (CNKI), were conducted from December 8 to 16, 2013. Two evaluators independently selected and reviewed the eligible studies. Changes in HbA1c, fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), BMI, and body weight were analyzed.ResultsAn analysis of 18 studies with 3798 subjects revealed that telecare significantly improved the management of diabetes. Mean HbA1c values were reduced by −0.54 (95% CI, −0.75 to −0.34; P<0.05), mean FPG levels by −9.00 mg/dl (95% CI, −17.36 to −0.64; P=0.03), and mean PPG levels reduced by −52.86 mg/dl (95% CI, −77.13 to −28.58; P<0.05) when compared with the group receiving standard care. Meta-regression and subgroup analyses indicated that study location, sample size, and treatment-monitoring techniques were the sources of heterogeneity.ConclusionsPatients monitored by telecare showed significant improvement in glycemic control in type 2 diabetes when compared with those monitored by routine follow-up. Significant reduction in HbA1c levels was associated with Asian populations, small sample size, and telecare, and with those patients with baseline HbA1c greater than 8.0%.

scholarly journals Tocilizumab in hospitalized patients with COVID-19: A meta analysis of randomized controlled trials

2021 ◽  
Author(s):  
Vijairam Selvaraj ◽  
Mohammad Saud Khan ◽  
Kwame Dapaah-Afriyie ◽  
Arkadiy Finn ◽  
Chirag Bavishi ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Controlled Trials ◽  
Standard Therapy ◽  
Treatment Guidelines ◽  
Meta Analysis ◽  
Hospitalized Patients ◽  
Controlled Trials ◽  
Mortality And Morbidity ◽  
Randomized Controlled ◽  
All Cause Mortality

ABSTRACTBackgroundTo date, only dexamethasone has been shown to reduce mortality in COVID-19 patients. Tocilizumab has been recently added to the treatment guidelines for hospitalized COVID-19 patients, but data remains conflicting.MethodsElectronic databases such as MEDLINE, EMBASE and Cochrane central were searched from March 1, 2020, until February 28th, 2021, for randomized controlled trials evaluating the efficacy of tocilizumab in hospitalized COVID-19 patients. The outcomes assessed were all-cause mortality at 28 days, mechanical ventilation, and time to discharge.ResultsEight studies (with 6,311 patients) were included in the analysis. In total, 3,267 patients received tocilizumab, and 3,044 received standard care/placebo. Pooled analysis showed a significantly decreased risk of all-cause mortality at 28 days (RR 0.90, 95% CI 0.83-0.97, p=0.009) and progression to mechanical ventilation (RR 0.79, 95% CI 0.70-0.90, p=0.0002) in the tocilizumab arm compared to standard therapy or placebo. In addition, there was a trend towards improved median time to hospital discharge (RR 1.18, 95% CI 1.05-1.34, p=0.007).ConclusionsTocilizumab therapy improves outcomes of mortality and need for mechanical ventilation, in hospitalized patients with COVID-19 infection compared with standard therapy or placebo. Our findings suggest the efficacy of tocilizumab therapy in hospitalized COVID-19 patients and strengthen the concept that tocilizumab is a promising therapeutic intervention to improve mortality and morbidity in COVID-19 patients.

Tamoxifen for the Prevention of Breast Cancer: Psychosocial Impact on Women Participating in Two Randomized Controlled Trials

2001 ◽  
Vol 19 (7) ◽  
pp. 1885-1892 ◽  
Author(s):  
Lesley Fallowfield ◽  
Anne Fleissig ◽  
Rob Edwards ◽  
Andrea West ◽  
Trevor J. Powles ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Group ◽  
Randomized Controlled Trials ◽  
Sexual Functioning ◽  
Self Report ◽  
Controlled Trials ◽  
Double Blind ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Prevention Of Breast Cancer

PURPOSE: The purpose of this study was to evaluate the psychosocial implications of tamoxifen versus placebo in women who are at increased risk of breast cancer. PATIENTS AND METHODS: The 488 women in the psychosocial study were recruited from participants in two placebo-controlled, double-blind, randomized, controlled trials that investigated the efficacy of tamoxifen in the prevention of breast cancer in women who are at high familial risk. During a 5-year period, repeated assessments were made of anxiety, psychological distress, and sexual functioning using standardized questionnaires before treatment at baseline and at 6-month intervals during the trial. RESULTS: Questionnaire completion over 5 years was good, with 71.1% of women returning at least 8 of 10 follow-up assessments. Although scores from individuals showed considerable fluctuation and variation over time, changes in anxiety, mood, and sexual functioning were not associated with treatment group. The number of symptoms reported at 48 months via a self-report cheklist were not associated with treatment group, but vasomotor symptoms were more frequent among tamoxifen-treated women. Symptoms of low energy, breast sensitivity, and visual blurring were reported most frequently in the placebo group. CONCLUSION: In general, these results are comparable to those from the National Surgical Adjuvant Breast and Bowel Project psychosocial study despite differences in study populations, methodology, and instruments. The long-term use of tamoxifen and other selective estrogen response modulators as preventive agents in high-risk groups has been questioned, but we found no evidence of treatment-related side effects that affect women’s psychosocial and sexual functioning.

scholarly journals Mind-Body Interventions, Psychological Stressors, and Quality of Life in Stroke Survivors

Stroke ◽  
2019 ◽  
Vol 50 (2) ◽  
pp. 434-440 ◽  
Author(s):  
Mary F. Love ◽  
Anjail Sharrief ◽  
Alejandro Chaoul ◽  
Sean Savitz ◽  
Jennifer E. Sanner Beauchamp
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trials ◽  
Small Sample ◽  
Controlled Trials ◽  
Stroke Survivors ◽  
Poststroke Depression ◽  
Randomized Controlled ◽  
Psychological Stressors ◽  
Biological Outcomes

Background and Purpose—Psychological stressors, including poststroke depression, poststroke anxiety, and posttraumatic stress disorder, are highly prevalent in stroke survivors. These symptoms exact a significant toll on stroke survivors. Clinical and research efforts in stroke recovery focus on motor disability, speech and language deficits, and cognitive dysfunction while largely neglecting psychological stressors. Evidence suggests mind-body interventions in other chronic illness populations decrease symptoms of depression, regulate immune responses, and promote resilience, yet similar studies are lacking in stroke populations. This review aims to synthesize evidence of the effects of mind-body interventions on psychological stressors, quality of life, and biological outcomes for stroke survivors.Methods—A systematic search of PubMed, PsycINFO, and CINAHL was conducted from database inception to November 2017.Results—Eight studies were included in the review, with a total of 292 participants. Mind-body interventions included yoga or tai chi. Of the 5 included randomized controlled trials, most were pilot or feasibility studies with small sample sizes. Psychological stressors, including poststroke depression and anxiety, along with the quality of life, improved over time, but statistically significant between-group differences were largely absent. The 3 included studies with a qualitative design reported themes reflecting improvement in psychological stressors and quality of life. No included studies reported biological outcomes.Conclusions—Studies of mind-body interventions suggest a possible benefit on psychological stressors and quality of life; however, rigorously designed, sufficiently powered randomized controlled trials with mixed-methods design are warranted to delineate specific treatment effects of these interventions. Studies with both biological and psychological stressors as outcomes would provide evidence about interaction effects of these factors on stroke-survivor responses to mind-body interventions.

scholarly journals Trigger Point Injections for Chronic Non-Malignant Musculoskeletal Pain: A Systematic Review

Pain Medicine ◽  
2009 ◽  
Vol 10 (1) ◽  
pp. 54-69 ◽  
Author(s):  
N. Ann Scott ◽  
Bing Guo ◽  
Pamela M. Barton ◽  
Robert D. Gerwin
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Musculoskeletal Pain ◽  
Systematic Reviews ◽  
Trigger Point ◽  
Small Sample ◽  
Controlled Trials ◽  
Safe Procedure ◽  
Randomized Controlled ◽  
Published Evidence

ABSTRACT Objective. This systematic review assessed the available published evidence on the efficacy and safety of using trigger point injection (TPI) to treat patients with chronic non-malignant musculoskeletal pain that had persisted for at least 3 months. Methods. All published systematic reviews or randomized controlled trials detailing the use of TPI in patients with chronic, non-malignant musculoskeletal pain (persisting for &gt;3 months) were identified by systematically searching literature databases and the Websites of various health technology assessment agencies, research registers, and guidelines sites up to July 2006. Results. Although no systematic reviews were identified, 15 peer-reviewed randomized controlled trials met the inclusion criteria. However, deficiencies in reporting, small sample sizes, and marked inter-study heterogeneity precluded a definitive synthesis of the data. TPI is a safe procedure when used by clinicians with appropriate expertise and training. It relieved symptoms when used as a sole treatment for patients with chronic head, neck, shoulder, and back pain or whiplash syndrome, regardless of the injectant used, and may be a useful adjunct to intra-articular injection in the treatment of osteoarthritis pain. Although the addition of TPI to stretching exercises augments treatment outcomes, this was also true of other therapies such as ultrasound and laser. Conclusion. The efficacy of TPI is no more certain than it was a decade ago as, overall, there is no clear evidence of either benefit or ineffectiveness. The only advantage of injecting anesthetic into trigger points may be to reduce the pain of the needling process, which may not be an insignificant benefit.

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