This study is a dose-escalating randomized open-label clinical trial … A randomized, double-blinded, placebo-controlled clinical trial was conducted at two … The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality. Design, Setting, and Participants The ACTIV-4B Outpatient Thrombosis Prevention Trial was designed as a minimal-contact, adaptive, randomized, double-blind, placebo-controlled trial to compare anticoagulant and antiplatelet therapy among 7000 symptomatic but clinically stable outpatients with COVID-19. Convalescent plasma is being used widely as a treatment for coronavirus disease 2019 (COVID-19). METHODS: In this randomized, double-blind clinical trial, patients with COVID-19 admitted to 2 referral tertiary hospitals in Mazandaran, Iran, were randomly divided into 2 groups: intervention and control. The efficacy outcomes were mortality, ventilatory support, intensive care unit (ICU) admission and length of hospital stay. Triple-blinded, randomized, placebo-controlled trial was conducted in Chile in a tertiary-care hospital able to provide on-site sCTA scans and ventilatory support when needed between August 2020 and March 2021. Incomplete reporting of RCTs can be … Setting 28 hospitals in Brazil, Canada, Ireland, Saudi Arabia, United Arab Emirates, and US. The Effect of Cognitive Behavioral Therapy on Depression, Anxiety, and Stress in Patients With COVID-19: A Randomized Controlled Trial Jinzhi Li 1 † , Xiuchuan Li 2 † , Jie Jiang 3 , Xuexue Xu 3 , Jing Wu 4 , Yuanyuan Xu 4 , Xin Lin 5 , John Hall 6 , Huashan Xu 7 … Incomplete reporting of RCTs can be … Testing the efficacy and safety of BIO101, for the prevention of respiratory deterioration, in patients with COVID-19 pneumonia (COVA study): a structured summary of a study protocol for a randomised controlled trial. The objective of this study is to evaluate the feasibility, safety and efficacy of nebulised surfactant in COVID-19 adult patients requiring mechanical ventilation for respiratory failure. Studies that mainstream science ignores: “Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance.” Wang, Y. et al. Methods: All adult patients with mild COVID-19 symptoms presented to King Abdulaziz University Hospital, Jeddah, Saudi Arabia, were recruited for an open label randomized clinical trial (RCT). Chronically ill elderly individuals require—in addition to protection from infection—regular … In a randomized trial conducted in 2020-2021 of patients with COVID-19 and severe hypoxemia, 12 mg of dexamethasone did not statistically significantly reduce the number of days patients were alive without life support at 28 days compared with 6 mg of dexamethasone. In this streamlined, randomised, controlled, open-label trial, underway at 177 hospitals in the UK, two hospitals in Indonesia, and two hospitals in Nepal, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. This large, international, randomized controlled clinical trial is designed to enable an expeditious, agile and concurrent evaluation of the benefits and risks of multiple candidate preventive vaccines against COVID-19 at international sites with sufficient COVID-19 attack rates. Methods: This study will be a … The primary outcome of the trial was the duration of hospitalization. In the HEP-COVID randomized clinical trial, therapeutic-dose LMWH reduced the composite of thromboembolism and death compared with standard heparin thromboprophylaxis without increased major bleeding among hospitalized patients with COVID-19 … Patients were randomized into a treatment group receiving atorvastatin + lopinavir/ritonavir or a control group receiving lopinavir/ritonavir alone. This study aimed to evaluate the effects of the widely used antiparasitic drug ivermectin on outcomes in patients with COVID-19. Methods We searched databases for randomised controlled studies evaluating efficacy and/or safety of colchicine as compared with supportive care in patients with COVID-19. Participants 203 adults aged 18 years and older with … The study, which is the first published randomized clinical trial studying the effectiveness of masks against the coronavirus, comes … Phase III, randomized, double-blind clinical trial. A systematic review and meta-analysis was conducted to determine the safety of COVID-19 vaccine candidates in randomized controlled trials (RCTs). First results from any randomized, controlled COVID-19 vaccine booster trial demonstrate a relative vaccine efficacy of 95.6% against disease during a period when Delta was the prevalent strain. Randomised controlled trials for COVID-19: evaluation of optimal randomisation methodologies-need for data validation of the completed trials and to improve ongoing and future randomised trial designs. The study investigates the efficacy of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir added on to standard of care compared to standard of care only in patients with COVID-19 disease. This is a multi-centre, randomized, double-blind placebo-controlled superiority trial. However, the National Institute of Health (NIH) and World Health Organization (WHO) currently state that studies on using ivermectin to treat COVID-19 patients remain inconclusive due to insufficient data. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease (COVID-19) patients. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or … One preclinical and 1 observational cohort clinical study found significant benefit of masks in limiting SARS-CoV-2 transmission. The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to evaluate the potential of ivermectin to reduce COVID-19 transmission in low risk, non-severe COVID-19 patients in the first 48 h after symptoms onset: a structured summary of a study protocol for a randomized control pilot trial. METHODS: This randomized, double-blind, placebo-controlled, clinical trial was done on hospitalized adult patients with confirmed COVID-19 infection. Main text. Results: Fourteen studies were included in this study. The Lancet 395 , … In this streamlined, randomised, controlled, open-label trial, underway at 177 hospitals in the UK, two hospitals in Indonesia, and two hospitals in Nepal, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Simulation mimicking a randomized controlled trial for antiviral drugs. Controlled randomized clinical trial on using ivermectin with doxycycline for treating COVID-19 patients in Baghdad, Iraq. Sholzberg, M., Tang, G.H., Negri, E. et al. A total of 20,000 parameter sets were randomly sampled from the estimated distributions of individual parameters. The trial was done in the community in Oxfordshire, UK. The first interim analysis of this randomized, double-blind, placebo-controlled, parallel-group trial shows that patients hospitalized for severe COVID-19 treated with L-arginine displayed a significantly reduced in-hospital stay vs placebo (log-rank p < 0.0001). Design, setting and … Center for Disease Control : RCT: Randomized clinical trial : COVID-19: Coronavirus disease 2019 : alum: Potassium aluminum sulfate : VLPs: Virus-like particles : ORs: Odds ratios : 6-HB: six-helical bundle : SARS-CoV-2: Severe acute respiratory syndrome coronavirus 2 : 95% CI: 95% confidence interval: GMT: Geometric mean titer : RBD: Receptor-binding domain : PLpro: Papain-like … In trial with more than 10,000 participants 16 years of age and older, COVID-19 booster was found to have a favorable safety profile. A large, randomized trial led by researchers at Stanford Medicine and Yale University has found that wearing a surgical face mask over the mouth and nose is an effective … They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. For more information about joining a clinical trial: Call 877-414-8106 Chat now. We identified no published clinical trials of the effect of remdesivir in patients with COVID-19. In just six months, the world’s largest randomized control trial on COVID-19 therapeutics has generated conclusive evidence on the effectiveness of repurposed drugs for the treatment of COVID-19. Methods and analysis This is an exploratory, multicentre, open-label, randomised controlled trial. Inspired by the growing body of scientific evidence that face masks have the potential to slow the spread of the disease and save lives (1–10), we conducted a cluster-randomized controlled trial covering 342,183 adults in 600 villages in rural Bangladesh with the … We conducted a randomized, double-blind, placebo-controlled trial to evaluate postexposure prophylaxis with hydroxychloroquine after exposure to Covid-19. pf-07302048 (bnt162 rna-based covid-19 vaccines) protocol c4591001 page 1 a phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of sars-cov-2 rna vaccine candidates against covid-19 in healthy individuals study sponsor: biontech In this randomized, double-blind clinical trial, patients with COVID-19 admitted to 2 referral tertiary hospitals in Mazandaran, Iran, were randomly divided into 2 groups: intervention and control. The goal of this study was to determine if proxalutamide, an androgen receptor antagonist, could be an effective treatment for men with COVID-19 in an outpatient setting. Coagulopathy of hospitalised COVID-19: A Pragmatic Randomised Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG – RAPID Trial): A structured summary of a study protocol for a randomised controlled trial. 1 During the next few weeks and months, the results of numerous RCTs involving therapies for COVID-19 will be reported. This study aims to evaluate the efficacy of oral sildenafil in treating COVID-19 inpatients showing perfusion abnormalities in sCTA. Objective To assess the effect of statin treatment versus placebo on clinical outcomes in patients with covid-19 admitted to the intensive care unit (ICU). This large, global randomized control trial is designed to provide robust results on whether a drug can save lives in those hospitalized with severe or critical COVID-19. Two districts have been randomly selected in each city, yielding a total of 24 registered hospitals. A stepped wedge cluster randomized control trial will be conducted in three selected cities of China: Wuhan, Suzhou, and Shenzhen. The allocation ratio is assumed as 1:1 (control:treatment). Methods: We performed an open-label, parallel-group, phase 2, randomised controlled trial (Steroids in COVID-19; STOIC) of inhaled budesonide, compared with usual care, in adults within 7 days of the onset of mild COVID-19 symptoms. The literature for the use of lopinavir-ritonavir in the treatment of COVID-19 is now available in the form of randomized controlled trials. Preprint posted October 27, 2020. doi: 10.1101/2020.10.26.20219345 Google Scholar We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Objective To determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19. September 1, 2021 - By Krista Conger. So, this systematic review aimed to find out the efficacy and safety outcomes in COVID-19 patients treated with lopinavir-ritonavir combination through the meta-analytic summary. Secondary outcomes included mask-wearing behavior, physical distancing behavior, and COVID-19 symptom prevalence. In this open-label, multicentre, randomised, controlled trial of patients at high risk hospitalised with confirmed COVID-19, a treatment regimen of standard in-hospital parenteral thromboprophylaxis and extended post-discharge thromboprophylaxis with rivaroxaban 10 mg/day for 35 days (SD 4), when compared with no anticoagulation, resulted in better clinical … We mimicked randomized controlled trials using the model including the effects of an antiviral drug. In a worldwide pandemic of Coronavirus disease 2019 (COVID-19), thousands of randomised controlled trials (RCTs) on COVID-19 treatment have been conducted over a short period, and 6,332 trials have been registered with clinicaltrials.gov to date [1], but research on the reporting quality of COVID-19 RCTs has been insufficient. During the emerging COVID-19 (coronavirus disease 2019) pandemic, initially there were no proven treatment options. In a worldwide pandemic of Coronavirus disease 2019 (COVID-19), thousands of randomised controlled trials (RCTs) on COVID-19 treatment have been conducted over a short period, and 6,332 trials have been registered with clinicaltrials.gov to date [1], but research on the reporting quality of COVID-19 RCTs has been insufficient. medRxiv . In addition to standard treatment for COVID-19, the intervention group received a single weight-based dose (0.2 mg/kg) of ivermectin; the control group received the standard of … As of September 2021, the COVID-19 pandemic has taken the lives of more than 4.7 million people. Different candidate vaccines may be available or suitable to enter the trial at different times; for … Randomized controlled trials (RCTs) suggest differences in the effect of therapeutic heparin between moderately and severely ill patients with COVID-19. Therefore, a large well designed randomized, double blinded, placebo-controlled trial to assess the efficacy of ivermectin is urgently needed. Minimal data are available from adequately powered randomized, controlled trials. Guidance on how to handle and safely continue such trials is lacking. The gold standard for testing drug treatments in people is the randomized, double-blind, placebo-controlled clinical trial. This was a cluster-randomized trial of community-level promotion of mask-wearing, designed to estimate the impact of interventions on SARS-CoV-2 symptomatic seroprevalence in Bangladesh from November 2020 to April 2021. S48 Lenzilumab efficacy and safety in newly hospitalized Covid-19 subjects: results from the LIVE-AIR phase 3 randomized double-blind placebo-controlled trial METHODS: We conducted a randomized controlled clinical trial on adults hospitalized with COVID-19. PRINCIPLE is a multicentre, open-label, multi-arm, prospective, randomised, controlled, adaptive platform trial of interventions against COVID-19 in people aged 65 years or older or 50 years or older with comorbidities, done remotely from a central trial site and at primary care centres in the UK. METHODS We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia Trial Design and Oversight. This study will conduct a rollout in these hospitals every 3 months. The present study is the joint analysis of the randomized clinical trial (RCT) that tested proxalutamide on patients hospitalized due to COVID-19 conducted in two different regions, as two different arms, aiming to provide the final results for the Proxa-Rescue AndroCoV Trial and to evaluate whether findings were consistent between arms. Objective To evaluate the effects of therapeutic heparin compared with prophylactic heparin among moderately ill patients with covid-19 admitted to hospital wards. Added value of this study Our study is the first randomised, double-blind, placebo-controlled clinical trial assessing the effect of intravenous Inspired by the growing body of scientific evidence that face masks have the potential to slow the spread of the disease and save lives (1–10), we conducted a cluster-randomized controlled trial covering 342,183 adults in 600 villages in rural Bangladesh with the … We identified no published clinical trials of the effect of remdesivir in patients with COVID-19. In a First, Randomized Study Shows That Masks Reduce COVID-19 Infections A large study co-authored by Yale SOM’s Jason Abaluck and Mushfiq Mobarak tested the effectiveness of a mask-promotion program in Bangladesh in increasing mask use and preventing symptomatic infections. To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19. Mortality, ventilatory support, intensive care unit ( ICU ) admission and length hospital. 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