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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42560   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

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    Summary
    EudraCT Number:2021-003717-18
    Sponsor's Protocol Code Number:215226/VIR-7831-5005
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-10
    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 ConcernedGreece - EOF
    A.2EudraCT number2021-003717-18
    A.3Full title of the trial
    An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a single intravenous or intramuscular dose of sotrovimab in pediatric participants with mild to moderate COVID-19 at high risk of disease progression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics, pharmacodynamics, and safety of single-dose sotrovimab in high-risk pediatric participants with mild to moderate COVID-19
    A.3.2Name or abbreviated title of the trial where available
    COMET-PACE
    A.4.1Sponsor's protocol code number215226/VIR-7831-5005
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/468/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research & Development Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportVir Biotechnology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 0800 783 9733
    B.5.5Fax numberNot Applicable
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameSotrovimab
    D.3.2Product code GSK4182136, VIR-7831
    D.3.4Pharmaceutical form Concentrate 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 INNSotrovimab
    D.3.9.1CAS number 2423014-07-5
    D.3.9.2Current sponsor codeVIR-7831 (GSK4182136)
    D.3.9.4EV Substance CodeSUB214951
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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 nameSotrovimab
    D.3.2Product code GSK4182136, VIR-7831
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSotrovimab
    D.3.9.1CAS number 2423014-07-5
    D.3.9.2Current sponsor codeVIR-7831 (GSK4182136)
    D.3.9.4EV Substance CodeSUB214951
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number62.5
    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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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
    COVID-19 at high risk of disease progression
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory 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
    To evaluate the pharmacokinetics by IV or IM administration of sotrovimab in children from birth to <18 years

    To evaluate the safety and tolerability of sotrovimab by IV or IM administration
    E.2.2Secondary objectives of the trial
    To evaluate disease progression following IV or IM administration of sotrovimab.

    To characterize the effect of IV or IM administration of sotrovimab on SARS-CoV-2 viral load in respiratory tract samples among participants infected with SARS-CoV-2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age
    1.Participant must be 32 weeks estimated gestational age (EGA), day of life (DOL) 0 to <18 years of age inclusive, at either the time of participant’s signed assent (if age-appropriate) or parent(s)/legally authorized representative signing the informed consent.

    Type of Participant and Disease Characteristics
    2. Participants with mild-moderate COVID-19, as defined by:
    • A positive SARS-CoV-2 test result by any validated qRT-PCR or other nucleic acid amplification test (NAAT) AND
    • SpO2 ≥94% on room air AND
    • Have one or more of the following symptoms: fever, chills, cough, sore throat, malaise, headache, joint or muscle pain, change in smell or taste, vomiting, diarrhea, shortness of breath, poor appetite or poor feeding, nasal congestion/runny nose, lethargy AND
    • Less than or equal to 7 days from onset of symptoms to dosing day (Day 1).

    3. Participants at risk of disease progression with at least one of the following criteria:
    • Age <1 year
    • Diabetes mellitus
    • Genetic or metabolic diseases
    • Obesity (as defined as body mass index (kg/m2) ≥95th percentile for age and sex based on local growth charts for children ≥2 years of age)
    • Cardiovascular disease
    • Sickle cell disease
    • Pulmonary disease
    • Neurologic disease
    • Immunosuppressed (due to certain medical conditions or being on medications that weaken the immune system
    o Use of systemic corticosteroids is included as defined by dose ≥0.5 mg/kg/day or 20 mg/day prednisone equivalents (whichever dose is the lower of the two) taken for ≥2 weeks
    • Baseline medical complexity (gastrostomy- or jejunostomy-dependence, parenteral nutrition dependence, tracheostomy-dependence, baseline oxygen requirement, use of CPAP/BiPAP/ventilator support).

    Weight
    4. Body weight with the range stated below:
    • Preterm newborn infants and term newborn infants: ≥2 kg
    • Children 2 years to <18 years:
    o Body mass index (BMI) ≥5th percentile for age based on local growth charts.

    Sex and Contraceptive/Barrier Requirements
    5. Male and/or female
    • Contraception and barriers as well as pregnancy testing is required for females only, as appropriate for the age and sexual activity of pediatric participants and as required by local regulations regarding the methods of contraception for those participating in clinical studies.
    • A female participant is eligible to participate if she is not breastfeeding and is either:
    • Premenarcheal or
    • Not pregnant as confirmed by a negative pregnancy test (serum or highly sensitive urine as required by local regulations) at Screening, before the first dose of study intervention, if of reproductive potential.
    o If a urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    o See protocol for additional requirements for pregnancy testing during the study participation.
    Women of childbearing potential (WOCBP) must commit to using a contraceptive method that is highly effective, with a failure rate of <1%, during the study intervention period and for at least 36 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure in relationship to the first dose of study intervention.
    The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early undetected pregnancy.
    6. The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant’s legal guardian and the participant’s assent, when applicable, before any study specific activity is performed (unless a waiver of informed consent has been granted by an Institutional Review Board/Ethics Committee. All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand.
    7. The participant capable of providing signed and dated written assent signs and dates a written assent form (age appropriate) and the parent/guardian signs and dates a written informed consent form (ICF) for study participation prior to the initiation of any study-related activities.

    Other
    8. A legal guardian or primary caregiver must be available to help the study-site personnel ensure follow-up; support the participant to attended assessment days according to the SoA (e.g., able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures); consistently and consecutively be available to provide information on the participant using the rating scales during the scheduled study visits; accurately and reliably dispense study intervention as directed.
    9. A legal guardian or primary caregiver must be able to accurately maintain the child’s take-home record, including items of general health.
    E.4Principal exclusion criteria
    Medical Conditions
    1. Pregnant or breastfeeding.
    2. Currently hospitalized, or judged by the investigator as likely to require hospitalization in the next 24 hours, due to severe or critical COVID-19.
    Note: If the infant has been hospitalized due to other reasons (e.g., prematurity) or will be hospitalized for reason of administering the study treatment then they can be included in the study.
    3. Respiratory rate:
    • 0-6 months: >60 breaths/minute (min)
    • 6 months to 5 years: >30 breaths/min
    • 6 years to <18 years: >20 breaths/min
    4. Shortness of breath at rest or respiratory distress.
    5. Shock (septic, neurogenic, anaphylactic, cardiogenic, or hypovolemic shock; systemic inflammatory response syndrome).
    6. Multiorgan dysfunction.
    7. Participants who, in the judgement of the investigator are likely to die in the next 7 days.
    8. Multisystem inflammatory syndrome in children (MIS-C) [CDC HAN, 2020], defined as a participant:
    a. Participants presenting with fever ≥38°C, laboratory evidence of inflammation (such as elevated C-reactive protein [CRP], erythrocyte sedimentation rate [ESR], fibrinogen, procalcitonin, d-dimer, ferritin, lactic acid, lactate dehydrogenase [LDH], interleukin 6 [IL-6], neutrophilia, lymphopenia or hypoalbuminemia) and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological);
    AND
    b. No alternative plausible diagnoses;
    AND
    c. Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or exposure to a suspected or confirmed COVID-19 case within the 4 weeks prior to the onset of symptoms.
    9. Post-conceptional age less than 32 completed weeks at time of Screening.
    10. History of sudden infant death or unexplained death in a sibling.
    11. For Cohort B only: Participant has any condition that would prohibit receipt of IM injections in the investigator’s opinion such as coagulation disorder, bleeding diathesis, or thrombocytopenia (platelet count <50,000/mm3).

    Prior/Concomitant Therapy
    12. Prior, current, or planned future use of any of the following treatments during the study period: COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (e.g., casirivimab/imdevimab), intravenous immunoglobulin (IVIG) for any indication, or dexamethasone specifically for treatment of COVID-19.
    13. Current use of COVID-19 treatment (authorized, approved, or investigational).
    14. The following exclusions related to use of an authorized or approved vaccine for SARS-CoV-2 are applicable:
    a) Receipt of any authorized or approved vaccine for SARS-CoV-2 within 48 hours prior to dosing.
    b) Planned use of any authorized or approved vaccine for SARS-CoV-2 within 90 days of study drug administration per current CDC recommendations.
    15. Receipt of any non-SARS-CoV-2 vaccines within 14 days (for non-live vaccines) or 28 days (for live vaccine) of Screening.

    Prior/Concurrent Clinical Study Experience
    16. Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, mAbs against SARS-CoV-2 (e.g. casirivimab/imdevimab) or IVIG within 3 months or within 5 half-lives of the investigational product (whichever is longer) prior to the Screening visit.
    17. Has participated, is participating, or plans to participate during the study period in a clinical research study evaluation of any authorized, approved or investigational vaccine for SARS-CoV-2.
    18. Currently enrolled in another clinical study.

    Other Exclusions
    19. Infants <24 weeks of age: maternal receipt of IVIG, SARS-CoV-2-directed convalescent plasma or SARS-CoV-2-directed mAb(s) within 3 months prior to birth or within 5 half-lives of the investigational product (whichever is longer).
    20. Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol through the end of the study.
    21. Known hypersensitivity to any constituent present in the investigational product.
    E.5 End points
    E.5.1Primary end point(s)
    Body weight-adjusted serum clearance of sotrovimab

    Serum PK of sotrovimab administered by IM injection or IV infusion (PK parameters may include Cmax, Tmax, AUCinf, t1/2, Vz, CL, F)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI) through Day 29 and Week 36
    E.5.2Secondary end point(s)
    Progression of COVID-19 through Day 29 as defined by need for attended medical visit* or escalation to higher level of medical care or death (*An attended medical visit includes visit to a hospital emergency room for management of illness or hospitalization for acute management of illness)

    Development of severe and/or critical respiratory COVID-19 as manifested by requirement for supplemental oxygen through Day 29* (For participants who require oxygen or respiratory support for premorbid conditions, disease progression is defined as any sustained (>24 hours) increase in the level or method of oxygen support required)

    Change from baseline in viral load in nasal secretions measured by qRT-PCR at Day 5, Day 8, and Day 11
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to E.5.2 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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Argentina
    Brazil
    Colombia
    Greece
    Philippines
    Russian Federation
    South Africa
    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
    The end of the study is defined as the date of last scheduled procedure for the last participant in the study globally.
    A participant is considered to have completed the study if he/she completes the Week 36 visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 72
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 6
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 48
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 72
    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 Decision2021-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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