covid randomized control trial

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. randomised­controlled­trial­to­prevent­ respiratory­deterioration­and­ hospitalisation­in­early­COVID-19 Annette Mollerup ,1,2 Sofus Christian Larsen,1 Anita Selmer Bennetzen,1 Marius Henriksen,3,4 Mette Kildevaeld Simonsen,5 Nina Weis ,4,6 Linette Marie Kofod,7 Berit Lilienthal Heitmann 1,8 To cite: Mollerup A, Larsen SC, 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. 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. A total of 20,000 parameter sets were randomly sampled from the estimated distributions of individual parameters. CORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections. 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. A recently published trial of face mask use to protect against COVID-19 demonstrated a key barrier to carrying out randomised trials in public health: the need for unattainably large sample sizes. METHODS: We conducted a randomized controlled clinical trial on adults hospitalized with COVID-19. This study will conduct a rollout in these hospitals every 3 months. The study, which is the first published randomized clinical trial studying the effectiveness of masks against the coronavirus, comes … Ten cases of severe COVID-19 were reported after the first dose was administered to both the vaccine intervention and the placebo … DOI: 10.1136/thorax-2021-btsabstracts.54 Corpus ID: 243875509. They were randomly divided into control or treatment groups, with the latter receiving 500 mg NSO (MARNYS® Cuminmar) twice daily for 10 days. 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 … This study is a dose-escalating randomized open-label clinical trial … This study was initiated in May 2021 and will end in July 2022. 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. Remdesivir in adults with severe COVID-19: A randomised, double-blind, placebo-controlled, multicentre trial. Scientists have conducted a first-in-the-world randomized placebo-controlled trial of third dose COVID-19 booster vaccine for transplant patients that … One preclinical and 1 observational cohort clinical study found significant benefit of masks in limiting SARS-CoV-2 transmission. 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. Multi-centre, three arm, randomized controlled trial on the use of methylprednisolone and unfractionated heparin in critically ill ventilated patients with pneumonia from SARS-CoV-2 infection: A structured summary of a study protocol for a randomised controlled trial. The Lancet 395 , … 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. Antiandrogens have demonstrated a protective effect for COVOD-19 patients in observational and interventional studies. Trial Design and Oversight. Secondary outcomes included mask-wearing behavior, physical distancing behavior, and COVID-19 symptom prevalence. Setting 28 hospitals in Brazil, Canada, Ireland, Saudi Arabia, United Arab Emirates, and US. 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. 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 … A comprehensive review for clinical trials assessing the safety of COVID-19 vaccines is urgently needed to make an accurate judgment for mass vaccination. In this randomized, double-blind, and placebo-controlled trial, we recruited 101 severe COVID-19 patients with lung damage. 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. Preprint posted October 27, 2020. doi: 10.1101/2020.10.26.20219345 Google Scholar The safety outcomes were adverse events, serious adverse events and diarrhoea. Simulation mimicking a randomized controlled trial for antiviral drugs. Patients were randomized into a treatment group receiving atorvastatin + lopinavir/ritonavir or a control group receiving lopinavir/ritonavir alone. The coronavirus disease 2019 (COVID-19) pandemic is a threat to ongoing clinical trials necessitating regular face-to-face, in-person meetings, particularly in participants with a high risk of complications. Therefore, a large well designed randomized, double blinded, placebo-controlled trial to assess the efficacy of ivermectin is urgently needed. 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 …  medRxiv . Incomplete reporting of RCTs can be … RECOVERY is a randomised trial investigating whether treatment with Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Synthetic neutralizing antibodies (REGN-COV2), Tocilizumab, Aspirin, Baricitinib, Infliximab, Empagliflozin or Anakinra (children only) prevents death in patients with … Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community The safety and scientific validity of this study is the responsibility of the … Based on an existing CBT protocol, a blended intervention of 17 weeks, Fit after COVID, was developed to treat severe fatigue after the acute phase of infection with SARS-CoV-2.  medRxiv . We identified no published clinical trials of the effect of remdesivir in patients with COVID-19. Participants 465 adults admitted … A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center (UNMC) in Omaha. Added value of this study Our study is the first randomised, double-blind, placebo-controlled clinical trial assessing the effect of intravenous We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has changed our lives. (“clinical trial” or “randomized controlled trial”). Dear Sir, We thank Ben W. Mol for his comments and questions, 1 and appreciate the meticulous reading of our recently published article. Setting Three Canadian provinces (Quebec, Ontario, and British Columbia). Participants 203 adults aged 18 years and older with … Added value of this study Our study is the first randomised, double-blind, placebo-controlled clinical trial assessing the effect of intravenous The ReCOVer study is a multicentre 2-arm randomised controlled trial (RCT) to test the efficacy of Fit after COVID on severe post-infectious fatigue. The scientific community has been investigating re-purposed treatments to prevent disease progression in coronavirus disease (COVID-19) patients. 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.” 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. We conducted a randomized, double-blind, placebo-controlled trial to evaluate postexposure prophylaxis with hydroxychloroquine after exposure to Covid-19. 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 … 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. For many public health interventions, the choice is not between sufficiently powered trials and underpowered trials, but between underpowered trials and no … Clinical trials help researchers find better ways to treat COVID-19 and other conditions. Methods: This study will be a … The Vitamin D and COVID-19 Trial (VIVID) is a nationwide randomized clinical trial in 2700 U.S. men and women to investigate whether taking a daily dietary supplement of vitamin D for 4 weeks reduces disease severity in participants newly diagnosed with COVID-19, and reduces the risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV … A double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19 through an intention-to-treat analysis. 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 … A systematic review and meta-analysis was conducted to determine the safety of COVID-19 vaccine candidates in randomized controlled trials (RCTs). Incomplete reporting of RCTs can be … A stepped wedge cluster randomized control trial will be conducted in three selected cities of China: Wuhan, Suzhou, and Shenzhen. The efficacy outcomes were mortality, ventilatory support, intensive care unit (ICU) admission and length of hospital stay. Phase III, randomized, double-blind clinical trial. This is a multi-centre, randomized, double-blind placebo-controlled superiority trial. 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). Busani, S., Tosi, M., Mighali, P. et al. 1 During the next few weeks and months, the results of numerous RCTs involving therapies for COVID-19 will be reported. Controlled randomized clinical trial on using ivermectin with doxycycline for treating COVID-19 patients in Baghdad, Iraq. Design, setting and … We identified no published clinical trials of the effect of remdesivir in patients with COVID-19. The primary outcome of the trial was the duration of hospitalization. Controlled randomized clinical trial on using ivermectin with doxycycline for treating COVID-19 patients in Baghdad, Iraq. 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. The trial was done in the community in Oxfordshire, UK. Regarding the first concern, our study started on March 23 and was finalized on June 1, 2020. Objective To determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19. 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. Guidance on how to handle and safely continue such trials is lacking. Main text. METHODS We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia 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 … The researchers reported eight cases of COVID-19 with onset at least 7 days after the second dose among the vaccine intervention group (BNT162b2b) and 162 cases among those randomly assigned to the placebo-controlled group. METHODS: This randomized, double-blind, placebo-controlled, clinical trial was done on hospitalized adult patients with confirmed COVID-19 infection. For more information about joining a clinical trial: Call 877-414-8106 Chat now. To date, more than 1000 studies addressing various aspects of COVID-19 are registered on ClinicalTrials.gov, including more than 600 interventional studies and randomized clinical trials (RCTs). During the emerging COVID-19 (coronavirus disease 2019) pandemic, initially there were no proven treatment options. This study aimed to evaluate the effects of the widely used antiparasitic drug ivermectin on outcomes 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. 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). 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. As of September 2021, the COVID-19 pandemic has taken the lives of more than 4.7 million people. 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. This study aims to evaluate the efficacy of oral sildenafil in treating COVID-19 inpatients showing perfusion abnormalities in sCTA. Methods and analysis This is an exploratory, multicentre, open-label, randomised controlled trial. Convalescent plasma is being used widely as a treatment for coronavirus disease 2019 (COVID-19). Studies of SARS-CoV-2 and face masks and randomized controlled trials (RCTs) of n ≥ 50 for other respiratory illnesses were included. 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. A randomized, double-blinded, placebo-controlled clinical trial was conducted at two … 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. 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. A fully remote, double-blind, placebo-controlled randomized trial, N=152 (80 of then assigned to fluvoxamine, and 72 assigned to placebo). Design Randomised, double blind, placebo controlled trial. 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. 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. To determine whether ivermectin treatment can prevent hospitalization in individuals with early COVID-19. The Passive Immunity Trial for Our Nation (PassITON) is a multicenter, placebo-controlled, blinded, randomized clinical trial being conducted in the USA to provide high-quality evidence on the … 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 … Objective To evaluate the effects of therapeutic heparin compared with prophylactic heparin among moderately ill patients with covid-19 admitted to hospital wards. Wang, Y. et al. Providing free masks to people in rural Bangladesh was one measure researchers tested to limit the spread of COVID-19. Innovations for Poverty Action. 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 searched PubMed, Embase, Web of … The literature for the use of lopinavir-ritonavir in the treatment of COVID-19 is now available in the form of randomized controlled trials. We mimicked randomized controlled trials using the model including the effects of an antiviral drug. 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. Different candidate vaccines may be available or suitable to enter the trial at different times; for … 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. 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. September 1, 2021 - By Krista Conger. Results: Fourteen studies were included in this study. This placebo-controlled, randomised, adaptive platform trial done among high-risk symptomatic Brazilian adults confirmed positive for SARS-CoV-2 included eligible patients from 11 clinical sites in Brazil with a known risk factor for progression to severe disease. 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. S48 Lenzilumab efficacy and safety in newly hospitalized Covid-19 subjects: results from the LIVE-AIR phase 3 randomized double-blind placebo-controlled trial Randomized controlled trials (RCTs) suggest differences in the effect of therapeutic heparin between moderately and severely ill patients with COVID-19. 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. (“clinical trial” or “randomized controlled trial”). Minimal data are available from adequately powered randomized, controlled trials. 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 … Two districts have been randomly selected in each city, yielding a total of 24 registered hospitals. Design Randomised controlled, adaptive, open label clinical trial. Sholzberg, M., Tang, G.H., Negri, E. 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). 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. 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. This trial investigates whether the use of face masks in the community will reduce wearers' risk of SARS-CoV-2 infection. Preprint posted October 27, 2020. doi: 10.1101/2020.10.26.20219345 Google Scholar 2 We agree that randomized controlled trials on COVID-19 should be accurate and trustworthy. 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. 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 Of therapeutic heparin in hospitalized patients with COVID-19 Chat now has been investigating re-purposed treatments to prevent disease in... Clinical efficacy of COVID-19 concern, our study started on March 23 and was finalized on June,... Sets were randomly sampled from the estimated distributions of individual parameters participants 16 years of age and,. An antiviral drug prevent disease progression in coronavirus disease 2019 ) pandemic, there! 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