scholarly journals Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)—study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Jan Maláska ◽  
Jan Stašek ◽  
František Duška ◽  
Martin Balík ◽  
Jan Máca ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Therapeutic Potential ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
University Hospitals ◽  
Open Label ◽  
Parallel Group ◽  
Trial Testing ◽  
Randomised Controlled

Abstract Background Since December 2019, SARS-CoV-2 virus has infected millions of people worldwide. In patients with COVID-19 pneumonia in need of oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day is currently recommended. However, the dose of 6 mg of dexamethasone is currently being reappraised and may miss important therapeutic potential or may prevent potential deleterious effects of higher doses of corticosteroids. Methods REMED is a prospective, open-label, randomised controlled trial testing the superiority of dexamethasone 20 mg (dexamethasone 20 mg on days 1–5, followed by dexamethasone 10 mg on days 6–10) vs 6 mg administered once daily intravenously for 10 days in adult patients with moderate or severe ARDS due to confirmed COVID-19. Three hundred participants will be enrolled and followed up for 360 days after randomization. Patients will be randomised in a 1:1 ratio into one of the two treatment arms. The following stratification factors will be applied: age, Charlson Comorbidity Index, CRP levels and trial centre. The primary endpoint is the number of ventilator-free days (VFDs) at 28 days after randomisation. The secondary endpoints are mortality from any cause at 60 days after randomisation; dynamics of the inflammatory marker, change in WHO Clinical Progression Scale at day 14; and adverse events related to corticosteroids and independence at 90 days after randomisation assessed by the Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days. The study will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. Discussion We aim to compare two different doses of dexamethasone in patients with moderate to severe ARDS undergoing mechanical ventilation regarding efficacy and safety. Trial registration EudraCT No. 2020-005887-70. ClinicalTrials.gov NCT04663555. Registered on December 11, 2020

scholarly journals Effect of Dexamethasone In Patients With ARDS And COVID-19 (REMED Trial) – Study Protocol For A Prospective, Multi-Centre, Open-Label, Parallel-Group, Randomized Controlled Trial

2021 ◽  
Author(s):  
Jan Maláska ◽  
Jan Stašek ◽  
František Duška ◽  
Martin Balík ◽  
Jan Máca ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Therapeutic Potential ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
University Hospitals ◽  
Open Label ◽  
Parallel Group ◽  
Trial Testing ◽  
Randomised Controlled

Abstract Background: Since December 2019, SARS-Co-2 virus has infected millions of people worldwide. In patients with COVID-19 pneumonia in need for oxygen therapy or mechanical ventilation, dexamethasone 6 mg per day is currently recommended. However, the dose of 6 mg of dexamethasone is currently being reappraised and may miss important therapeutic potential or may prevent a potential deleterious effects of a higher doses of corticosteroids. Methods: REMED is a prospective, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg (dexamethasone 20 mg on day 1–5, followed by dexamethasone 10 mg on day 6–10) vs 6 mg administered once daily intravenously for 10 days in adult patients with moderate or severe ARDS due to confirmed COVID-19. 300 participants will be enrolled and followed up for 360 days after randomization. Patients will be randomised in a 1:1 ratio into one of the two treatment arms. Following stratification factors will be applied: age, Charlson Comorbidity index, CRP levels and trial centre. Primary endpoint is number of ventilator-free days (VFDs) at 28 days after randomisation. Secondary endpoints are mortality from any cause at 60 days after randomisation; Dynamics of inflammatory marker, change in WHO Clinical Progression Scale at Day 14; Adverse events related to corticosteroids and independence at 90 days after randomisation assessed by Barthel Index.The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days. The study will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. Discussion: We aim to compare two different dose of dexamethasone in patients with moderate to severe ARDS undergoing mechanical ventilation regarding efficacy and safetyTrial registration: EudraCT No.:2020-005887-70 and ClinicalTrials.gov Identifier: NCT04663555 on December 11, 2020 on ClinicalTrials.gov

scholarly journals Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

2021 ◽  
Author(s):  
Jan Maláska ◽  
Jan Stašek ◽  
František Duška ◽  
Martin Balík ◽  
Jan Máca ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Primary Objective ◽  
Efficacy And Safety ◽  
Open Label ◽  
Parallel Group ◽  
Secondary Objective ◽  
Randomised Controlled

Abstract ObjectivesThe primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.

Antimicrobial central venous catheters do not reduce infections in pre-term babies

BMJ ◽  
2019 ◽  
pp. l4993
Author(s):  
Rob Cook ◽  
Duncan Fortescue-Webb ◽  
Rosie Martin
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Technology ◽  
Central Venous Catheters ◽  
Central Venous ◽  
Open Label ◽  
Health Technology Assessment Programme ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

The studyGilbert R, Brown M, Rainford N et al. Antimicrobial-impregnated central venous catheters for prevention of neonatal bloodstream infection (PREVAIL): an open-label, parallel-group, pragmatic, randomised controlled trial. Lancet Child Adolesc Health 2019;3:381-90.The study was funded by the NIHR Health Technology Assessment programme (project number 12/167/02).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000782/antimicrobial-central-venous-catheters-for-pre-term-babies-do-not-reduce-infections

scholarly journals Safety and Efficacy of Ayurvedic Interventions and Yoga on Long Term Effects of COVID-19: a Structured Summary of a Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Babita Yadav ◽  
Amit Rai ◽  
Pallavi Suresh Mundada ◽  
Richa Singhal ◽  
BCS Rao ◽  
...  
Keyword(s):  
Exploratory Study ◽  
Controlled Trial ◽  
Primary Objective ◽  
Self Management ◽  
Intervention Period ◽  
Long Term Effects ◽  
Open Label ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Objectives: Primary Objective• To assess the efficacy of Ayurveda interventions and Yoga in rehabilitation of COVID-19 cases suffering with long term effects of COVID 19 as compared to WHO Rehabilitation Self-Management after COVID-19- Related Illness.Secondary Objective• To assess the safety of Ayurvedic interventions in cases suffering with long term effects of COVID 19Trial design: Multi-centric, randomized, controlled, parallel group, open-label, exploratory study. The study duration is 9 months and the intervention period is 90 days from the day of enrolment of the participant.

scholarly journals An open-label, parallel-group, randomised controlled trial of antiseptic mouthwash versus antibiotics for oropharyngeal gonorrhoea treatment (OMEGA2)

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Eric P. F. Chow ◽  
Kate Maddaford ◽  
Jane S. Hocking ◽  
Catriona S. Bradshaw ◽  
Rebecca Wigan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Health Centre ◽  
Nucleic Acid Amplification ◽  
Open Label ◽  
Parallel Group ◽  
Randomised Controlled ◽  
New Treatments ◽  
Clinical Trials Registry

Abstract New treatments for oropharyngeal gonorrhoea are required to address rising antimicrobial resistance. We aimed to examine the efficacy of a 14-day course of mouthwash twice daily compared to standard treatment (antibiotic) for the treatment of oropharyngeal gonorrhoea. The OMEGA2 trial was a parallel-group and open-labelled randomised controlled trial among men with untreated oropharyngeal gonorrhoea that was conducted between September 2018 and February 2020 at Melbourne Sexual Health Centre in Australia. Men were randomised to the intervention (rinsing, gargling and spraying mouthwash twice daily for 14 days) or control (standard treatment) arm and followed for 28 days. Participants in both arms were advised to abstain from sex and kissing with anyone for 14 days after enrolment. Oropharyngeal swabs were collected at baseline, Day 14 and Day 28 and tested for Neisseria gonorrhoeae by nucleic acid amplification test (NAAT) and culture. The primary outcome was the detection of oropharyngeal N. gonorrhoeae by NAAT at Day 14 after treatment. This trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12618001380280). This trial stopped early due to a high failure rate in the mouthwash arm. Twelve men were randomly assigned to either mouthwash (n = 6) or standard treatment (n = 6). Of the 11 men who returned at Day 14, the cure rate for oropharyngeal gonorrhoea in the mouthwash arm was 20% (95% CI 1–72%; 1/5) and in the standard treatment arm was 100% (95% CI 54–100%; 6/6). A 14-day course of mouthwash failed to cure a high proportion of oropharyngeal gonorrhoea cases.

Comparison of two dose escalation strategies of methotrexate in active rheumatoid arthritis: a multicentre, parallel group, randomised controlled trial

2021 ◽  
pp. annrheumdis-2021-220512
Author(s):  
Siddharth Jain ◽  
Varun Dhir ◽  
Amita Aggarwal ◽  
Ranjan Gupta ◽  
Bidyalaxmi Leishangthem ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Controlled Trial ◽  
Group Differences ◽  
Drug Discontinuation ◽  
Open Label ◽  
Intention To Treat ◽  
Parallel Group ◽  
Registration Number ◽  
Randomised Controlled

ObjectivesThere are no head-to-head trials of different dose escalation strategies of methotrexate (MTX) in RA. We compared the efficacy, safety and tolerability of ‘usual’ (5 mg every 4 weeks) versus ‘fast’ (5 mg every 2 weeks) escalation of oral MTX.MethodsThis multicentre, open-label (assessor blinded) RCT included patients 18-55 years of age having active RA with disease duration <5 years, and not on DMARDs. Patients were randomized 1:1 into usual or fast escalation groups, both groups starting MTX at 15 mg/week till a maximum of 25 mg/week. Primary outcome was EULAR good response at 16 weeks, secondary outcomes were ΔDAS28 and adverse effects (AE). Analyses were intention-to-treat.Results178 patients with mean DAS28-CRP of 5.4(1.1) were randomized to usual (n=89) or fast escalation groups (n=89). At 16 weeks, there was no difference in good EULAR response in the usual (28.1%) or fast escalation (22.5%) groups (p=0.8). There was no difference in mean ΔDAS28-CRP at 8 weeks (-0.9, -0.8, p=0.72) or 16 weeks (-1.3, -1.3, p=0.98). Even at 24 weeks (extended follow-up), responses were similar. There were no inter-group differences in ΔHAQ, or MTX-polyglutamates 1-3 levels at 8 or 16 weeks. Gastrointestinal AE were higher in the fast escalation group over initial 8 weeks (27%, 40%, p=0.048), but not over 16 weeks. There was no difference in cytopenias, transaminitis, or drug discontinuation/dose reduction between the groups. No serious AE were seen.ConclusionA faster MTX escalation strategy in RA was not more efficacious over 16-24 weeks, and did not significantly increase AE, except higher gastrointestinal AE initially.Trial registration numberCTRI/2018/12/016549

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