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    Summary
    EudraCT Number:2020-000982-18
    Sponsor's Protocol Code Number:NOR-SOLIDARITY
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-24
    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 ConcernedNorway - NOMA
    A.2EudraCT number2020-000982-18
    A.3Full title of the trial
    The NOR Solidarity multicenter trial on the efficacy of different anti-viral drugs in SARS-CoV-2 infected patients (COVID-19).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the efficacy of different anti-viral drugs in SARS-CoV-2 infected patients (COVID-19).
    A.3.2Name or abbreviated title of the trial where available
    NOR-SOLIDARITY
    A.4.1Sponsor's protocol code numberNOR-SOLIDARITY
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportOslo university hospital
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo university hospital
    B.5.2Functional name of contact pointSect. Clin. Imm. & Infect. Diseases
    B.5.3 Address:
    B.5.3.1Street AddressSognsvannsveien 20
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0372
    B.5.3.4CountryNorway
    B.5.4Telephone number+4723071916
    B.5.6E-mailandreas.barrattdue@gmail.com
    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 Yes
    D.2.1.1.1Trade name Plaquenil
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis Norge
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 namePlaquenil
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhydroxychloroquine sulphate
    D.3.9.1CAS number 747-36-4
    D.3.9.3Other descriptive nameHYDROXYCHLOROQUINE SULFATE
    D.3.9.4EV Substance CodeSUB02587MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 2
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameRemdesivir
    D.3.9.4EV Substance CodeSUB195655
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-COV-2 infection
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10037373
    E.1.2Term Pulmonary disorder
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of Remdesivir and Hydroxychloroquine on all-cause in-hospital mortality compared to standard of care.

    E.2.2Secondary objectives of the trial
    - To assess the effect of Remdesivir and Hydroxychloroquine treatment on hospital duration, receipt of ventilation or intensive care, and to identify any serious adverse reactions.
    - To assess the effect of Remdesivir and Hydroxychloroquine treatment on 28 days mortality, viral clearance, kidney and myocardial failure, co-infections, organ dysfunction and health-related Quality of Life.

    Exploratory:
    Assess the effect of Remdesivir and Hydroxychloroquine on biomarkers and safety.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    POPulation PharmacoKinetic (POPPK) study of antiviral drugs in SARS-CoV-2 infected patients participating in The Investigational NOR-SOLIDARITY study. Version 6, 28 April 2020.

    Primary objective:
    To develop novel population pharmacokinetic models for Remdesivir and Hydroxychloroquine in moderate/severe COVID-19 patients.

    Explorative objective:
    Assess viral decay, CRP/ IL-6 levels, SUSARs and Grade 3 and 4 AEs, myocardial failure/ QT-time prolongation, eGFR reduction of > 50% from baseline.
    E.3Principal inclusion criteria
    1. Adult patients, 18 years and above
    2. Confirmed SARS-2-CoV-2 infection by PCR
    3. Admitted to the hospital ward or the ICU
    4. Subjects (or legally authorized representative) provides written informed consent prior to initiation of the study
    5. No anticipated transfer within 72 hours to a non-study hospital

    E.4Principal exclusion criteria
    1. Severe co-morbidity with life expectancy <3 months according to investigators assessment
    2. ASAT/ALAT > 5 times the upper limit of normal
    3. Acute co-morbidity within 7 days before inclusion such as myocardial infarction
    4. Known intolerance and hypersensitivity to any of the components of the available study drug.
    5. Pregnancy or breast feeding
    6. Any reason why, in the opinion of the investigators, the patient should not participate
    7. Participation in a potentially confounding drug or device trial during the course of the study
    8. Prolonged QTc interval (>470 ms)
    9. Already receiving any of the study drugs
    10. Patients with psoriasis
    11. Patients on concomitant medication which is part of the list of prohibited medications have to be excluded from the current study (see protocol section 4.3)
    E.5 End points
    E.5.1Primary end point(s)
    All-cause in-hospital mortality.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hospitalisation.
    E.5.2Secondary end point(s)
    During hospitalisation:
    - Receipt of mechanical ventilation
    - Time to first receiving and duration of mechanical ventilation
    - Receipt of intensive care
    - Duration of intensive care
    - Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSARs)

    During hospitalisation:
    - Viral clearance as assessed by SARS-CoV 2 PCR in oropharyngeal specimens during hospitalization
    - Occurence of kidney failure (eGFR <40 mL/min)
    - Occurence of myocardial involvement assessed by biochemical markers as well as echocardiography measuring left ventricular ejection fraction within the first week
    - Occurence of co-infections (super infections with bacteria, fungi and other virus)

    Assessed after 28 days:
    - Overall survival
    - Patient reported respiratory health status by CAT (Chronic Obstructive Pulmonary Disease (COPD) assessment Test) score

    Assessed after 3 months:
    - Occurence of systolic and diastolic cardiac dysfunction and level of remodelling asssessed by echocardiography and biochemical markers
    - Occurence of pulmonary dysfunction and level of fibrosis assessed by spirometry and thoracic CT scan
    - Health related quality of life assessed by the RAND 36-item Short Form Health Survey (SF-36) item scores and the 5-dimension EuroQol (EQ-5D) questionnaires index value.

    Exploratory:
    Biomarkers during hospitalisation and after 3 months
    - Inflammatory and anti-inflammatory mediators as assessed in serum and plasma
    - Markers of extracellular matrix remodelling
    - Markers of endothelial activation
    - Markers of platelet activation
    - Cellular immunity
    - Prognostic biosignatures (RNA)
    - Gut microbiota assessed by rectal swab
    - Pharmacokinetics during hospitalization
    - Adverse events during hospitalization
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care
    E.8.2.4Number of treatment arms in the trial3
    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 concerned29
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 609
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 609
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    When the patient lacks the capacity to consent to participation, an appropriate representative will be approached by staff trained in consent procedures that protect the rights of the patient, and adhere to the Declaration of Helsinki.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1218
    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
    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 Opinion2020-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
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