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    The EU Clinical Trials Register currently displays   38147   clinical trials with a EudraCT protocol, of which   6265   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:010
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-001052-18
    A.3Full title of the trial
    A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for European Union/United Kingdom Sites
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for Eurpean Union/United Kingdom Sites
    A.3.2Name or abbreviated title of the trial where available
    Adaptive COVID-19 Treatment Trial in the EU & UK (ACTT-EU/UK)
    A.4.1Sponsor's protocol code number010
    A.5.4Other Identifiers
    Name:DMID - NIHNumber:20-0006, Version no. 3.0
    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 supportNational Institute of Health
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportUniversity of Minnesota
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnited States NIAID, Division of Microbiology and Infectious Diseases (DMID) National Institute of Health (NIH)
    B.5.2Functional name of contact pointJanice Arega
    B.5.3 Address:
    B.5.3.1Street Address5601 Fishers Lane
    B.5.3.2Town/ cityBethesda
    B.5.3.3Post code20892
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1240292-0928
    B.5.5Fax number+1301480-3579
    B.5.6E-mailaregaj@niaid.nih.gov
    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 nameREMDESEVIR
    D.3.2Product code GS-5734
    D.3.4Pharmaceutical form Lyophilisate for solution for 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
    D.3.9.2Current sponsor codeGS-5734
    D.3.9.4EV Substance CodeSUB195655
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 placeboSolution for infusion
    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
    Influenza COVID-19
    E.1.1.1Medical condition in easily understood language
    Influenza COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10022005
    E.1.2Term Influenza viral infections
    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
    To evaluate the clinical efficacy, as assessed by time to recovery or different investigational therapeutics as compared to the control arm.
    E.2.2Secondary objectives of the trial
    Key Secondary: To evaluate the clincial efficacy of different investigational therapeutics relative to the control arm in adults hospitalised with COVID-19 accroding to clinical status (8-point scale) at Day 15.
    Additional secondary:
    1. To evaluate the clinical efficaty of different invesitgational therapeutics as compared to the control arm assessed by: Clinical Severity, NEWS, Oxygenation, Non-invasive ventilation/high flow oxygen, Invasive Mechanical Ventilation/ECMO, Hospitalisation, Mortality: 14-day, 29-day.
    2. To evaluate the safety of different investigational therapeutics as compared to the control arm as assessed by:
    Commulative incidence of SAE thorough Day 29, Commulative incidence of Grade 3 and 4 clincial and/or laboratory AEs through Day 29
    Discontinuation or temporary suspension of infusions, Changes in laboratory values over time (analysis of lab. values in addition to AEs noted above
    Exploratory with stored samples (separate consent required)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Admitted to a hospital with synmptoms suggestive of COVID-19 infection
    2. Subject (or legally authorised representative) provides informed consent prior to initiation of any study procedures
    3. Subject (or legally authorised representative) understands and agrees to comply wiht planned study procedures
    4.Male or non-pregnant female adult ≥ 18 years of age at time of enrollment
    5. Has laboratory - confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen as documented by either of the following: PCR positive in sample collected < 72 hours prior to randomisation OR PCR positive in sample collected ≥ 72 hours prior to randomisation, documented inabilty to obtain a repeat sample (e.g. due to lack of testing supplies limited testing capacity, results taking > 24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection
    6. Illness of any duaration, and at least one of the following:
    Radiographic infiltrates by imagin (chest X-ray, CT-scanm etc.) OR 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 incluidng hormonal contraception from the time of screening through Day 29
    8. Agrees to not participate in another clinical trial for treatment of COVID-19 or SARS-CoV-2 thorugh Day 29
    E.4Principal exclusion criteria
    1. ALT/AST > 5 times the upper limit of normal
    2. Estimated glumerular filtration rate (eGFR) < 30 ml/min (inlcuding patientes receiving hemodialysis or hemofiltration)
    3. Pregnancy or breast feeding
    4. Anticipated discharge from the hospital or 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)
    Primary endpoints:
    Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale:
    Hospitalised, not requireing supplemental oxygen - no longer requires ongiong medical care
    Not hospitalised, limitation on activities and/or requiering home oxygen
    Not hospitalised, no limitations on activities
    Recovery is evaluated up until Day 29
    Key Secondary:
    Death
    Hospitalised on invasive mechanical ventilation or ECMO
    Hospitalised on non-invasive ventilation or high flow oxygen devices
    Hospitalised, requiring supplemental oxygen
    Hospitallised, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
    Hospitalised, not requiring supplemental oxygen - no longer requires ongoing medical care
    Not hospitalised, limitation on activities and/or requiring home oxygen
    Not hospitalised, no limitations on activities
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be assessed daily while hospitalised.
    If the subjects discharged from the hospital they will have a study visit at Days 15, 22 and 29.
    For discharged subjects, it is preferred that athe Day 15 and 29 visits are in person to obtain safety laboratory tests and (for consenting subjects) OP swab and blood (serum only) samples for secondary research as well as clinical outcome data.
    The day 22 vist may be conducted by phone
    E.5.2Secondary end point(s)
    Clinical outcome assessed using ordinal scale daily while hospitalised and on Days 15, 22 and 29
    NEWS assessed daily while hospitalised and on Day 15 and 29
    Days of supplemental oxygen (if applicable) up to Day 29
    Days of non-invasive ventilation/high flow oxygen up to Day 29
    Days of invasive mechanical ventilation/ECMO (if applicable) up to Day 29
    Days of hospitalisation up to Day 29
    Date and cause of death (if applicable)
    SAEs
    Grade 3 and 4 AEs
    WBC, with differential, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, AST, and PT on Day 1, days 3, 5, 8 and 11 (while hospitalized) and Day 15 and 29 (if attends in-person visit or still hospitalized).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Subjects will be assessed daily while hospitalised.
    If the subjects discharged from the hospital they will have a study visit at Days 15, 22 and 29.
    For discharged subjects, it is preferred that athe Day 15 and 29 visits are in person to obtain safety laboratory tests and (for consenting subjects) OP swab and blood (serum only) samples for secondary research as well as clinical outcome data.
    The day 22 vist may be conducted by phone
    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 Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Adaptive
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 800
    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)
    None
    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 INSIGHT (International Network for Strategic Initiatives in Global HIV Trials)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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