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    The EU Clinical Trials Register currently displays   38201   clinical trials with a EudraCT protocol, of which   6274   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001052-18
    Sponsor's Protocol Code Number:INSIGHTPROTOCOL010
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2020-001052-18
    A.3Full title of the trial
    A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalised Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicentre, Adaptive, Randomised, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalised Adults
    A.3.2Name or abbreviated title of the trial where available
    Adaptive COVID-19 Treatment Trial (ACTT)
    A.4.1Sponsor's protocol code numberINSIGHTPROTOCOL010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04280705
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1249-9599
    A.5.4Other Identifiers
    Name:ACTT-EU/UK Number:010
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegents of the University of Minnesota
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity of Minnesota, USA
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMRC Clinical Trials Unit at UCL
    B.5.2Functional name of contact pointSarah Pett
    B.5.3 Address:
    B.5.3.1Street Address90 High Holborn
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1V 6LJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 20 7670 4700
    B.5.5Fax number+44 (0)20 7670-4818.
    B.5.6E-mails.pett@ucl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRemdesivir
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRemdesivir (active drug Triphosphate)
    D.3.9.1CAS number 1809249-37-3
    D.3.9.2Current sponsor codeGS-5734
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numberConc nos=5mg/mL
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 (Coronavirus RNA)
    E.1.1.1Medical condition in easily understood language
    COVID-19 (A respiratory disease caused by a novel coronavirus)
    E.1.1.2Therapeutic area Health Care [N] - Environment and Public Health [N06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to compare the clinical status of patients in the remdesivir and N-saline placebo groups at Day 15 of follow-up using an ordinal outcome with 8 clinical states. Specifically, patients will be categorized into one of the following 8 mutually exclusive categories on Day 15:
    • Death;
    • Hospitalised, on invasive mechanical ventilation or Extracorporeal
    membrane oxygenation (ECMO);
    • Hospitalised, on non-invasive ventilation or high flow oxygen devices;
    • Hospitalised, requiring supplemental oxygen;
    • Hospitalised, not requiring supplemental oxygen - requiring ongoing
    medical care (COVID-19 related or otherwise);
    • Hospitalized, not requiring supplemental oxygen - no longer requires
    ongoing medical care;
    • Not hospitalized, limitation on activities and/or requiring home oxygen;
    • Not hospitalized, no limitations on activities.

    The rationale behind this approach is to estimate in a clinically meaningful way whether the study drug has had a
    E.2.2Secondary objectives of the trial
    To compare participants in the remdesivir and N-saline placebo groups for the following secondary outcomes:
    • Clinical Severity
    o Ordinal scale:
    - Time to an improvement of one category and two categories from Day 1 (baseline) using an ordinal scale.
    - Subject clinical status using ordinal scale at Days 3, 5, 8, 11, 22, and 29.
    - Mean change in the ordinal scale from Day 1 to Days 3, 5, 8, 11, 15, 22, and 29
    • National Early Warning Score (NEWS*):
    - Time to discharge or to a NEWS of ≤2 and maintained for 24 hours, whichever occurs first.
    - Change from Day 1 to Days 3, 5, 8, 11, 15, and 29 in NEWS.

    *The NEW score is a simple severity of illness scoring system that the Royal College of Physicians, UK has developed and validated. It scores physiological parameters that would be routinely collected in hospitalised patients including pulse, respiratory rate, oxygen saturation, blood pressure, pulse and level of consciousness (i.e. alert vs. not).

    • Oxygenation:
    - Oxygenation free days
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Admitted to a hospital with symptoms suggestive of COVID-19 infection.
    2. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
    3. Understands and agrees to comply with planned study procedures.
    4. Male or non-pregnant female adult ≥18 years of age at time of enrolment.
    5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen collected < 72 hours prior to randomization.
    Note – 72 hours is not necessarily time from initial diagnosis. If ≥72 hours since positive PCR, the PCR may be repeated to assess eligibility.
    6. Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, OR Requiring supplemental oxygen, OR Requiring mechanical ventilation.
    7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
    8. Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2.
    E.4Principal exclusion criteria
    1. ALT/AST > 5 times the upper limit of normal.
    2. Estimated glomerular filtration rate (eGFR) < 50 or requiring dialysis.
    3. Pregnancy or breast feeding.
    4. Anticipated transfer to another hospital which is not a study site within 72 hours.
    5. Allergy to any study medication.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to compare the clinical status of patients in the remdesivir and N-saline placebo groups at Day 15 of follow-up using an ordinal outcome with 8 clinical states. Specifically, patients will be categorized into one of the following 8 mutually exclusive categories on Day 15:
    • Death;
    • Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO);
    • Hospitalised, on non-invasive ventilation or high flow oxygen devices;
    • Hospitalised, requiring supplemental oxygen;
    • Hospitalised, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise);
    • Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;
    • Not hospitalized, limitation on activities and/or requiring home oxygen;
    • Not hospitalized, no limitations on activities.
    The rationale behind this approach is to estimate in a clinically meaningful way whether the study drug has had a favourable clinical impact on the patient.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15
    E.5.2Secondary end point(s)
    Other endpoints include:
    1) Differences in time-to-event endpoints (e.g., time to at least a one category improvement in ordinal scale) by treatment will be summarized with Kaplan-Meier curves and 95% confidence bounds. The same procedure will be used to compare time to at least a two category improvement.
    2) Change in ordinal scale at specific time points will be summarized by proportions (e.g., proportion
    who have a 1-, 2-, 3-, or 4-point improvement or 1-, 2-, 3-, 4-point worsening).
    3) Duration of event (e.g., duration of mechanical ventilation) will be summarized according to median days with quartiles.
    4) Binary data (e.g., incidence of new oxygen use) will be summarized as a percent with 95% confidence intervals. Comparisons between arms will be presented as differences in proportions with 95% confidence intervals.
    5) Categorical data (e.g., 28-day mortality or ordinal scale by day) may be summarized according to proportions by category and/or odds ratios with confidence intervals.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 29
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Denmark
    Germany
    Greece
    Italy
    Portugal
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 440
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There are no arrangements for the participants to receive any more remdesivir treatment after follow-up of the study is complete (Day 29). Patients will continue to be under the medical care of their local physician/hospital.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation MRC Clinical Trials Unit at UCL
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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