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    The EU Clinical Trials Register currently displays   42564   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-003690-21
    Sponsor's Protocol Code Number:R10933-10987-COV-2067
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-30
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-003690-21
    A.3Full title of the trial
    A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS CoV 2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult Patients With COVID-19
    A.4.1Sponsor's protocol code numberR10933-10987-COV-2067
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04425629
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 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 nameREGN10933
    D.3.2Product code REGN10933
    D.3.4Pharmaceutical form Solution for injection/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 INNREGN10933
    D.3.9.2Current sponsor codeREGN10933
    D.3.9.3Other descriptive nameREGN10933
    D.3.9.4EV Substance CodeSUB215763
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Yes
    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 nameREGN10987
    D.3.2Product code REGN10987
    D.3.4Pharmaceutical form Solution for injection/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 INNREGN10987
    D.3.9.2Current sponsor codeREGN10987
    D.3.9.3Other descriptive nameREGN10987
    D.3.9.4EV Substance CodeSUB215764
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Yes
    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 injection/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
    Coronavirus disease 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1:
    -To evaluate the safety and tolerability of REGN10933+REGN10987 vs placebo
    -To evaluate the virologic efficacy of REGN10933+REGN10987 vs placebo in reducing viral shedding of SARS-CoV-2

    Phase 2:
    -To evaluate the virologic efficacy of REGN10933+REGN10987 vs placebo in reducing viral shedding of SARS-CoV-2

    Phase 3:
    -To evaluate the clinical efficacy of REGN10933+REGN10987 vs placebo
    E.2.2Secondary objectives of the trial
    Phase 1
    -Evaluate additional indicators of virologic efficacy of REGN10933+REGN10987 (REGN-COV2) vs placebo
    -Estimate clinical efficacy of REGN-COV2 vs placebo
    -Compare RT-qPCR results acquired with different sample types
    -Characterize PK profiles of REGN10933 and REGN10987 in serum
    -Assess immunogenicity of REGN10933 and REGN10987
    Phase 2
    -Evaluate additional indicators of virologic efficacy of REGN-COV2 vs placebo
    -Evaluate clinical efficacy of REGN-COV2 vs placebo
    -Evaluate safety and tolerability of REGN-COV2 vs placebo
    -Compare RT-qPCR results acquired with different sample types
    -Characterize concentrations of REGN10933 and REGN10987 in serum
    -Assess immunogenicity of REGN10933 and REGN10987
    Phase 3
    -Evaluate virologic efficacy of REGN-COV2 vs placebo in reducing viral shedding of SARS CoV 2
    -Evaluate safety and tolerability of REGN-COV2 vs placebo
    -Characterize concentrations of REGN10933 and REGN10987 in serum
    -Assess immunogenicity of REGN10933 and REGN10987
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    -Has SARS-CoV-2-positive antigen or molecular diagnostic test (by validated SARS-CoV-2 antigen, RT-PCR, or other molecular diagnostic assay, using an appropriate sample such as NP, nasal, oropharyngeal [OP], or saliva) ≤72 hours prior to randomization. A historical record of positive result from test conducted ≤72 hours prior to randomization is acceptable.
    -Meets one of the following 2 criteria:
    a. Symptomatic Cohort (All Phases): Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤7 days before randomization or
    b. Asymptomatic Cohort (Phase 2): Meets all of the following:
    -Has had no symptoms consistent with COVID-19 (as determined by the investigator) occurring at any time <2 months prior to randomization
    -Has had no positive SARS-CoV-2 test results from a sample collected >7 days prior to randomization
    -Has had no known contact (of any duration) with an individual who has confirmed COVID-19 or confirmed positive SARS-COV-2 test result >14 days prior to randomization.

    NOTE: Other Protocol defined Inclusion criteria apply
    E.4Principal exclusion criteria
    Key Exclusion Criteria:
    -Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient) at randomization, due to COVID-19
    -Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
    -Prior, current, or planned future use of any of the following treatments: COVID-19 convalescent plasma, mAbs against SARS-CoV-2, intravenous immunoglobulin (IVIG) (any indication), systemic corticosteroids (any indication), or COVID-19 EUA-approved treatments, where prior use is defined as the past 30 days or less than 5 half-lives of the investigational product (which is longer) from screening

    NOTE: Other Protocol defined Exclusion criteria apply
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1
    a)Proportion of patients with treatment-emergent SAEs
    b)Proportion of patients with infusion-related reactions (grade ≥2)
    c)Proportion of patients with hypersensitivity reactions (grade ≥2)
    d)Time-weighted average change from baseline in viral shedding, as measured by RT-qPCR in NP swab samples.
    Phase 2
    Time-weighted average change from baseline in viral shedding, as measured by RT-qPCR in NP swab samples.
    Phase 3
    Proportion of patients with ≥1 COVID 19 related medically-attended visit
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1
    a)Through day 29
    b)Through day 4
    c)Through day 29
    d)Through day 22,
    Phase 2: Through day 22
    Phase 3: Through day 29
    E.5.2Secondary end point(s)
    1. Time-weighted average change from baseline in viral shedding measured by RT-qPCR in saliva samples (Phase 1 Only)
    2. Time-weighted average change from baseline in viral shedding measured by RT-qPCR in nasal swab samples (Phase 1 Only)
    3. Time to negative RT-qPCR in all tested samples with no subsequent positive RT-qPCR in any tested samples (Phase 1 Only)
    4. Time to negative RT-qPCR in NP swabs with no subsequent positive RT-qPCR (Phase 2, Phase 3)
    5. Change from baseline in viral shedding as measured by RT-qPCR in NP swabs
    6. Change from baseline in viral shedding as measured by RT-qPCR in saliva samples (Phase 1 Only)
    7. Change from baseline in viral shedding as measured by RT-qPCR in nasal swabs (Phase 1 Only)
    8. Correlation of RT-qPCR results over time between different sample types (NP, nasal, and saliva) (Phase 1 Only)
    9. Concordance of RT-qPCR results over time between different sample types (NP, nasal, and saliva) (Phase 1 Only)
    10. Time-weighted average change from baseline in viral shedding
    11. Proportion of patients with at least two COVID-19 related medically attended visits
    12. Total number of COVID-19 related medically-attended visits
    13. Proportion of patients admitted to a hospital due to COVID-19
    14. Proportion of patients admitted to an intensive care unit (ICU) due to COVID-19 (Phase 2, Phase 3)
    15. Proportion of patients at least 1 outpatient or telemedicine visit due to COVID-19
    16. Proportion of patients requiring mechanical ventilation due to COVID-19 (Phase 2, Phase 3)
    17. Number of days of hospitalization due to COVID-19 (Phase 2, Phase 3)
    18. Number of deaths due to any cause (All-Cause Mortality) (Phase 2, Phase 3)
    19. Serum concentration of REGN10933 over time
    20. Serum concentration of REGN10987 over time
    21. Assessment of PK parameter: maximum serum concentration observed (Cmax) of REGN10933 and REGN10987 (Phase 1 only)
    22. Assessment of PK parameter: Cmax-to-dose ratio (Cmax/dose) of REGN10933 and REGN10987 (Phase 1 only)
    23.Assessment of PK parameter: Time to Cmax (tmax) for REGN10933 and REGN10987 (Phase 1 only)
    24. Assessment of PK parameter: Area Under the Curve (AUC) computed from time zero to the time of the last positive concentration (AUClast) for REGN10933 and REGN10987 (Phase 1 only)
    25. Incidence of anti-drug antibodies (ADA) to REGN10933 and REGN10987
    26. Time to first onset of symptoms consistent with COVID-19 (asymptomatic cohort only)
    27. Duration of symptoms consistent with COVID-19
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline up to Day 22
    2. Baseline up to Day 22
    3. Through Day 29
    4. Through Day 29
    5. Baseline up to Day 29
    6. Baseline up to Day 29
    7. Baseline up to Day 29
    8. Up to Day 29
    9. Up to Day 29
    10. Baseline up to Day 29
    11. Through Day 29
    12. Through Day 29
    13. Through Day 29
    14. Through Day 29
    15. Through Day 29
    16. Through Day 29
    17. Through Day 29
    18. Through Day 29
    19. Through Day 29
    20. Through Day 29
    21. Through Day 29
    22. Through Day 29
    23. Through Day 29
    24. Through Day 29
    25. Through Day 29
    26. Through Day 29
    27. Through 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    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 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 trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    Brazil
    Chile
    Mexico
    Romania
    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
    Last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 1259
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 109
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 1368
    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 Decision2020-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-02
    P. End of Trial
    P.End of Trial StatusCompleted
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