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    Clinical Trial Results:
    REmimazolam infusion in the context of Hypnotic Shortage in the Critical care Unit during the pandemic of COVID-19. The non-randomized, non-controlled, pilot, open, mono-centric REHSCU study.

    Summary
    EudraCT number
    		 2020-003689-37
    Trial protocol
    		 FR  
    Global end of trial date
    24 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2023
    First version publication date
    01 Jan 2023
    Other versions
    Summary report(s)
    		 Final report_summary

    Trial information

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    Trial identification
    Sponsor protocol code
    RC20_0319
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04611425
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU de Nantes
    Sponsor organisation address
    1 place Alexis Ricordeau, Nantes, France,
    Public contact
    Direction Recherche et Innovation, CHU de Nantes, +33 0253482835, bp-prom-regl@chu-nantes.fr
    Scientific contact
    Direction Recherche et Innovation, CHU de Nantes, +33 0253482835, bp-prom-regl@chu-nantes.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Oct 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to assess the balance safety-efficacy of Remimazolam in the ICU during the first 8 hours after the beginning of infusion.
    Protection of trial subjects
    Remimazolam is a novel benzodiazepine with promising pharmacokinetic and pharmacodynamic properties. It has been used in hundreds of patients worldwide in major cardiac and non-cardiac surgeries involving co-morbid patients, and in the critical care theatre. The safety data are extremely reassuring. The benefit/risk balance of the REHSCU study, in order to confirm the safety and efficacy of Remimazolam in the ICU in the context of a major hypnotic shortage in the setting of the COVID-19 pandemic, is highly favourable.
    Background therapy
    		 The worldwide COVID-19 pandemic has led to a dramatic increase in the number of patients hospitalized in intensive care units for an acute respiratory failure in all countries. This situation has quickly led to massive shortages in masks, mechanical ventilation machines and common medications such as hypnotics. The reasons for such shortages are multiple: dramatic increase of the demand, production discontinuation because of shutdowns in multiple countries, and withholding of products by producing countries. All countries over the world are currently experiencing a major shortage in basic hypnotic medications (propofol, midazolam) in the intensive care as well as in the operating theatre. Remimazolam is a novel benzodiazepine with a very short half-life that has been administered in patients undergoing major surgery, as well as in the intensive care unit. We propose to perform a pilot study assessing the benefit-risk ratio of Remimazolam in our critical care units during the COVID-19 pandemic.
    Evidence for comparator
    		 Non applicable.
    Actual start date of recruitment
    30 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    22
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 With the inclusion criteria we have adopted, thirty patients will therefore be required. Inclusion : 11 months. Follow-up : 5 days.

    Pre-assignment
    Screening details
    		 - Next-of-kin, Legal representative written informed consent or emergency consent - Affiliation with French social security system or beneficiary from such system

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Remimazolam
    Arm description
    		 Remimazolam (CNS 7056) is a novel benzodiazepine. It is administered via a catheter (central or peripheric) intra-venously. Patients will receive Remimazolam for a maximum of 48 hours after the beginning of infusion. Sedation may be interrupted any time, if the patient no longer needs general anaesthesia. The attending physician will be responsible for this decision.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Remimazolam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    the initial dose of infusion will be within a 0.2-0.5 mg/min range. The dose of Remimazolam will be adapted to our protocol of sedation-analgesia protocol. The maximum dose of Remimazolam will be set at 1 mg/min.

    Number of subjects in period 1
    		Remimazolam
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 All patients received Remimazolam.

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 22 22
        From 65-84 years
    		 8 8
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 59.5 (21 to 82) -
    Gender categorical
    30 patients were recruited, 23 men and 7 women.
    Units: Subjects
        Female
    		 7 7
        Male
    		 23 23

    End points

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    End points reporting groups
    Reporting group title
    Remimazolam
    Reporting group description
    		 Remimazolam (CNS 7056) is a novel benzodiazepine. It is administered via a catheter (central or peripheric) intra-venously. Patients will receive Remimazolam for a maximum of 48 hours after the beginning of infusion. Sedation may be interrupted any time, if the patient no longer needs general anaesthesia. The attending physician will be responsible for this decision.

    Primary: Efficacy

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    End point title
    		 Efficacy [1]
    End point description
    Sedation event: the investigator will check if Remimazolam provides an adequate level of sedation assessed with the Richmond Assessment Sedation Scale. The level of sedation will be set by the attending physician and is usually set at-1/0. The investigator will also monitor the need to use standard hypnotic drugs within this time frame as further medication (propofol, midazolam, dexmedetomidine) in case of Remimazolam inefficacy (Richmond Assessment Sedation Scale).
    End point type
    Primary
    End point timeframe
    8 hours after the beginning of infusion
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: it is a description of the study
    End point values
    		 Remimazolam
    Number of subjects analysed
    30
    Units: percentage
    30
    No statistical analyses for this end point

    Primary: Safety

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    End point title
    		 Safety [2]
    End point description
    Cardiovascular event: Hypotension will be defined as a Mean Arterial Pressure ≤65mmHg or an increase ≥50% of the dose of norepinephrine (if appropriate), sustained over one hour after the beginning of Remimazolam.
    End point type
    Primary
    End point timeframe
    8 hours after the beginning of infusion
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: it is a description of the study
    End point values
    		 Remimazolam
    Number of subjects analysed
    30
    Units: percentage
    30
    No statistical analyses for this end point

    Secondary: Biological data

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    End point title
    		 Biological data
    End point description
    Routine laboratory tests
    End point type
    Secondary
    End point timeframe
    4 days
    End point values
    		 Remimazolam
    Number of subjects analysed
    30
    Units: percentage
    30
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    5 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 30 (3.33%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Vascular access site complication
    Additional description: venotoxicity
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 30 (70.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hepatic enzyme abnormal
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Mean arterial pressure decreased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Troponin increased
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Endotracheal intubation complication
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    5 / 30 (16.67%)
         occurrences all number
    5
    Thrombophlebitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Atrial fibrillation
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Bradycardia
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    5
    Blood and lymphatic system disorders
    Hyperleukocytosis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Large intestine perforation
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2021
    Addition of an emergency procedure for patient inclusion Extension of the recruitment period by an additional 12 months
    06 May 2021
    Update of the relative's information note following the implementation of the emergency procedure
    02 Jul 2021
    Changement de PI sur site

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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