scholarly journals Design of a Randomized Controlled Trial for Ebola Virus Disease Medical Countermeasures: PREVAIL II, the Ebola MCM Study

2016 ◽  
Vol 213 (12) ◽  
pp. 1906-1913 ◽  
Author(s):  
Lori E. Dodd ◽  
Michael A. Proschan ◽  
Jacqueline Neuhaus ◽  
Joseph S. Koopmeiners ◽  
James Neaton ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Ebola Virus ◽  
Virus Disease ◽  
Controlled Trial ◽  
Ebola Virus Disease ◽  
Randomized Controlled ◽  
Medical Countermeasures

scholarly journals 843. The PALM Consortium: A Multicenter, Multioutbreak Randomized Controlled Trial of Ebola Virus Disease Therapeutics

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S12-S13
Author(s):  
Sabue Mulangu
Keyword(s):  
Randomized Controlled Trial ◽  
Ebola Virus ◽  
Virus Disease ◽  
Controlled Trial ◽  
Ebola Virus Disease ◽  
Cold Chain ◽  
Baseline Risk ◽  
Treatment Unit ◽  
Randomized Controlled ◽  
Comparative Safety

Abstract Background Recent outbreaks of Ebola virus disease in the Democratic Republic of the Congo (DRC) reinforce the desperate need to establish definitively the comparative safety and efficacy of different medical countermeasures (MCM). Methods Through a multipartner governance framework under WHO coordination, the Institut National de Recherche Biomédicale and NIAID collaborated with clinical partners (the MOH, ALIMA, MSF) to launch a randomized controlled trial in 2018 in the North Kivu/Ituri provinces of DRC. PCR+ participants receiving enhanced supportive care are being randomized 1:1:1:1 to receive either ZMapp™ (control arm), remdesivir, mAb114, or REG-EB3 according to standard treatment regimens. Stratification is by site, country, and baseline nucleoprotein (NP) PCR cycle threshold (CT) ≤ 22 or > 22. The primary objective is a comparison of 28-day mortality relative to the control arm. The planned accrual is for 125 patients per arm. Secondary objectives include an evaluation of the comparative safety and tolerability of the 4 investigational MCMs, relative changes in viral load over time, comparisons of treatment efficacy according to baseline risk categories, 58-day mortality, RNA clearance from semen, and an assessment of the validity of drug-class comparisons, including efficacy. The study is monitored by an independent data and safety monitoring committee (DSMB). Results Enrollment commenced in the Ebola Treatment Unit in Beni in November, 2018, with sites in Butembo and Katwa added in early 2019. Time from study concept initiation to study start was only 3.5 months. Ongoing hurdles encountered to date include maintenance of cold chain requirements for the MCMs and marked volatility in the security situation surrounding sites affecting staff and patient safety. Despite these challenges, data quality and completed follow-up have been remarkably high and by mid-April, 2019, accrual to date (see table) had already surpassed the predefined threshold triggering an interim DSMB review. Conclusion Scientifically rigorous and ethically sound clinical research can take place during disease outbreaks even within a conflict zone. Results about the relative efficacy of the evaluated investigational MCMs are pending the completion of the trial. Disclosures All Authors: No reported Disclosures.

scholarly journals A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics

2019 ◽  
Vol 381 (24) ◽  
pp. 2293-2303 ◽  
Author(s):  
Sabue Mulangu ◽  
Lori E. Dodd ◽  
Richard T. Davey ◽  
Olivier Tshiani Mbaya ◽  
Michael Proschan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Ebola Virus ◽  
Virus Disease ◽  
Controlled Trial ◽  
Ebola Virus Disease ◽  
Randomized Controlled

scholarly journals Clearing the fog: Is Hydroxychloroquine effective in reducing Corona virus disease-2019 progression: A randomized controlled trial

2020 ◽  
Author(s):  
Sultan Mehmood Kamran ◽  
Zill-e-Humayun Mirza ◽  
Arshad Naseem ◽  
Rizwan Azam ◽  
Naqeeb Ullah ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Disease Progression ◽  
Virus Disease ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Military Hospital ◽  
Control Group ◽  
Randomized Controlled ◽  
And Control

AbstractBackgroundHydroxychloroquine (HCQ) has been considered to treat Coronavirus disease 2019 (COVID-19) but data on efficacy is conflicting. we analyzed the efficacy of HCQ) in addition to standard of care (SOC) compared with SOC alone in reducing disease progression in Mild COVID-19MethodsA single centre open label randomized controlled trial during 10th April to 31st May 2020 was conducted at Pak emirates Military Hospital (PEMH) Five hundred patients of both genders having age between 18-80 years with Mild COVID-19 were enrolled. Patients assigned to standard dose of HCQ plus SOC were 349 while 151 patients received SOC (control group). Primary outcome was progression of disease while secondary outcome was PCR negativity on day 7 and 14. The results were analyzed on SPSS version 23. P value <0.05 was considered significant.ResultsMedian age of intervention group (34 ± 11.778 years) and control group (34 ± 9.813 years). Disease progressed in 16 patients, 11 (3.15%) were in intervention group as compared to 5 (3.35%) in control group, (P value = 0.865). PCR negativity in intervention and control groups were (day 7, 182 (52.1%) vs. 54 (35.7%) (P value = 0.001), (day 14, 244 (69.9%) vs. 110 (72.8%) (P value = 0.508). Consecutive PCR negativity at day 7 and 14 was observed in 240 (68.8%) in intervention group compared to 108 (71.5%) in control group. (P value = 0.231).ConclusionAddition of HCQ to SOC in Mild COVID-19 neither stops disease progression nor help in early and sustained viral clearance.Clinical Trial numberNCT04491994 available at ClinicalTrials.gov

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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