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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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).

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    Summary
    EudraCT Number:2021-006056-13
    Sponsor's Protocol Code Number:D8850C00006
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-05-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-006056-13
    A.3Full title of the trial
    Covid-19: Open-Label, Uncontrolled, Single dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of AZD7442 in Pediatric Participants Aged ≥ 29 weeks Gestational Age to < 18 years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Pharmacokinetics (behavior of drug inside the body), Pharmacodynamics (biochemical and physiological effects of drugs), and Safety of AZD7442 in children aged ≥ 29 Weeks Gestational Age (measure of the age of a pregnancy) to < 18 Years
    A.3.2Name or abbreviated title of the trial where available
    TRUST
    A.4.1Sponsor's protocol code numberD8850C00006
    A.5.4Other Identifiers
    Name:Investigational New Drug (IND) numberNumber:150712
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/235/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Study Information Centre
    B.5.3 Address:
    B.5.3.1Street AddressSödertälje
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailInformation.Center@astrazeneca.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 nameCilgavimab
    D.3.2Product code AZD1061
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCilgavimab
    D.3.9.1CAS number 2420563-99-9
    D.3.9.2Current sponsor codeAZD1061
    D.3.9.3Other descriptive namemonoclonal antibody (mAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 nameTixagevimab
    D.3.2Product code AZD8895
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTixagevimab
    D.3.9.1CAS number 2420564-02-7
    D.3.9.2Current sponsor codeAZD8895
    D.3.9.3Other descriptive namemonoclonal antibody (mAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    • To evaluate the serum concentrations of AZD7442 after a single IM or IV dose in pediatric participants.

    • To evaluate the safety and tolerability of AZD7442 after a single IM or IV dose in pediatric participants.
    E.2.2Secondary objectives of the trial
    All Cohorts
    • To evaluate the pharmacodynamics (PD) of AZD7442 after a single IM or IV dose in pediatric participants
    • To evaluate the immunogenicity profile of AZD7442 after a single IM or IV dose in pediatric participants.

    Cohort I (Prophylaxis)
    • To evaluate the incidence of SARS-CoV-2 infections with or without COVID-19 symptoms after a single IM or IV dose of AZD7442 in pediatric participants.

    Cohort 2 and Cohort 3 (Treatment)
    • To quantify SARS-CoV-2 viral loads after a single IM or IV dose of AZD7442 in pediatric participants.
    • To evaluate the proportion of participants with progression of COVID-19 after a single IM or IV dose of AZD7442 in pediatric participants.
    • To evaluate COVID-19-related death after a single IM or IV dose of AZD7442 in pediatric participants.

    Cohort 3 (Severe COVID-19)
    • To evaluate the time to sustained recovery from severe COVID-19 after a single IM or IV dose of AZD7442 in pediatric participants.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participant must be aged ≥ 29 weeks to < 18 years of age.
    • Participant must weigh a minimum of 1.5 kg.

    COHORT 1
    • Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
    • Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
    • A negative RT-PCR test collected ≤ 3 days before Day 1 or a negative rapid SARS-CoV-2 antigen test at screening.
    • No COVID-19 symptoms prior to enrollment within 10 days of dosing.
    • Increased risk for SARS-CoV-2 infection.

    COHORT 2
    • Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
    • Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
    • A positive RT-PCR test collected ≤ 3 days before Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
    • Symptomatic participants must be dosed with IMP no more than 7 days from the self-reported date of first reported sign/symptom.
    • ≥ 92% oxygen saturation at rest within 24 hours before Day 1 unless the participant is a regular receiver of chronic supplementary oxygen for a lung condition.

    COHORT 3
    • Participants hospitalized with COVID-19 between the onset of symptoms and dosing AZD7442 of ≤ 7 days.
    • A positive RT-PCR test collected ≤ 3 days before Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
    • Spontaneous blood Alanine Aminotransferase (ALT)/Aspartate Transaminase (AST) levels ≤ 5 times the ULN.
    • Glomerular Filtration Rate (GFR) ≥ 30 mL/min.

    ROUTE OF ADMINISTRATION
    - Participants will receive IM AZD7442 unless they meet any of the following criteria for IV
    administration:
    • Severe COVID-19.
    • Contraindication of intramuscular (IM) dose due to thrombocytopenia, coagulation defects or any other condition that would compromise the absorption of AZD7442 or safety of the participant.
    • A central intravenous (IV) line.
    Physician considers IV the appropriate route.

    SEX
    • Contraceptive use by post-pubescent males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (female participants who are not of child-bearing potential are defined as female participants who have not yet reached puberty).
    E.4Principal exclusion criteria
    MEDICAL CONDITIONS
    • Cohort 1: Significant infection or other acute illnesses including fever on or the day prior to or day of receiving AZD7442.
    • History of SARS-CoV-1 or Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
    • Cohorts 1 and 2: Current need for immediate medical attention in an emergency room service or current need for hospitalization.
    • Mechanical ventilation or extracorporeal membrane oxygenation requirement for COVID-19.
    • History of allergic or reaction to any component of the study drug formulation.
    • History of hypersensitivity, injection/infusion-relation reactions or severe adverse reactions following administration of a mAb.
    • Co-morbidity requiring surgery within 7 days prior to study entry or is deemed life-threatening within 30 days prior to study entry.


    THERAPY PRIOR ENROLLMENT
    • Prior receipt of convalescent COVID-19 plasma/sera or hyperimmune globulin therapy.
    • Prior receipt of mAb/biologic indicated for the prevention of SARS-CoV-2, treatment of COVID-19, or expected receipt during the period of study follow-up.
    • Prior receipt of a COVID-19 vaccine ≤ 14 days before screening or plan to receive a COVID-19 vaccination ≤ 14 days after IMP administrationat study Visit 1.

    OTHERS
    • Post-pubertal females who are pregnant or breast-feeding.
    •History of alcohol or drug abuse within the past 2 years OR positive urine drug or alcohol screening.
    • Vulnerable persons (ward of the state, kept in detention).
    E.5 End points
    E.5.1Primary end point(s)
    • Serum concentrations of AZD7442 when administered as a single IM or IV dose.

    • PK parameters
    - Maximum serum concentration (Cmax)
    - Time to reach maximum serum concentration (tmax)
    - Terminal half-life (t1/2)
    - Area under the serum concentration versus time curve from time zero to time of last measurable
    concentration (AUC0-last)
    - Area under the serum concentration versus time curve extrapolated to infinity (AUC0-inf)
    - Time to last measurable concentration (tlast)
    - Percentage of AUC0-inf extrapolated to infinity (% AUCex)
    PK parameters for IM:
    - Apparent total clearance (CL/F)
    - Apparent volume of distribution based on terminal phase (Vz/F)
    PK parameters for IV:
    - Systemic clearance (CL)
    - Volume of distribution at steady state (Vss)

    • Model-derived predicted serum AZD7442 concentrations and AUC0-inf.

    • Number of participants with adverse events (Treatment Emergent Adverse Events [TEAEs], Serious Adverse Events [SAEs], and Adverse Event of Special Interests [AESIs]).
    • Safety laboratory parameters (hematology, clinical chemistry, coagulation, and urinalysis); 12 lead safety ECG; vital signs (BP, pulse rate, tympanic membrane temperature, and respiratory rate), and physical examination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 366, Early Discontinuation Visit.

    Day 1 to Day 366, Early Discontinuation Visit (Number of participants with adverse events)
    E.5.2Secondary end point(s)
    All Cohorts (Other than Neonates)
    • Titer of SARS-CoV-2 neutralizing antibodies.
    • Number of participants with positive/negative antidrug antibody (ADA) result and neutralizing antibodies to AZD7442.

    Cohort 1 (Prophylaxis)
    • Incidence of SARS-CoV-2 infections with and without COVID-19 symptoms.

    Cohort 2 and Cohort 3 (Treatment):
    • Change from baseline to Day 8 in viral load as measured by qRT-PCR.
    • Proportion of participants with progression of COVID-19 through Day 29.
    • The incidence of COVID-19-related death occurring after dosing with IMP through 90 days.

    Cohort 3 (Severe COVID-19)
    • Time to sustained recovery.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 366, Early Discontinuation Visit.

    Day 1 to Day 90 (Cohort 2 and 3 [Treatment] - The incidence of COVID-19-related death occurring after dosing with IMP through 90 days).

    Day 1 to Day 366 (Cohort 3 [Severe COVID-19] - Time to sustained recovery).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    This is not a First In Human but, a First In Pediatric Population trial.
    E.7.2Therapeutic exploratory (Phase II) No
    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 trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Ukraine
    Brazil
    Mexico
    United Kingdom
    United States
    Belgium
    Germany
    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 trial is defined as the last visit of the last subject.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 100
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 4
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 4
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 36
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 46
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric participants aged ≥ 29 weeks Gestational Age to < 18 years.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 150
    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 Decision2022-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-04-16
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