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    Summary
    EudraCT Number:2021-006960-26
    Sponsor's Protocol Code Number:NOR-LAABis-2022
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-08-24
    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 number2021-006960-26
    A.3Full title of the trial
    COVID-19 PROPHYLAXIS IN IMMUNOSUPPRESSED PATIENTS WITH NO/POOR SARS-COV-2 VACCINE RESPONSE USING LONG-ACTING ANTIBODIES (AZD7442)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROPHYLAXIS OF COVID-19 USING LONG-ACTING ANTIBODIES AGAINST CORONAVIRUS IN PATIENTS WITH REDUCED IMMUNE SYSTEM THAT HAS NOT RESPONDED TO VACCINES
    A.3.2Name or abbreviated title of the trial where available
    NOR-LAABis-2022
    A.4.1Sponsor's protocol code numberNOR-LAABis-2022
    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 - Rikshospitalet
    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 supportAstraZeneca
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Horspital - Rikshospitalet
    B.5.2Functional name of contact pointAnders Åsberg
    B.5.3 Address:
    B.5.3.1Street AddressSognsvannsveien 20
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0424
    B.5.3.4CountryNorway
    B.5.4Telephone number+4723071937
    B.5.5Fax number+4723073865
    B.5.6E-mailanders.asberg@ous-hf.no
    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 Evusheld
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 namecilgavimab/tiksagevimab
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    Injection (Noncurrent)
    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) Yes
    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
    Kidney transplant recipients with suboptimal immune response to previous SARS-CoV-2 vaccinations
    E.1.1.1Medical condition in easily understood language
    Kidney transplanted patient with to low response to previous corona vaccinations
    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 PT
    E.1.2Classification code 10074555
    E.1.2Term Transplantation complication
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10077912
    E.1.2Term Renal retransplantation
    E.1.2System Organ Class 100000004865
    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 pharmacokinetics of AZD7442 in immunosuppressed patients with no or suboptimal vaccine response.
    E.2.2Secondary objectives of the trial
    To assess safety and efficacy of AZD7442 to induce protective immunity against SARS-CoV-2 in immunosuppressed patients as well as investigate PK interactions with immunosuppressive drugs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Kidney transplant recipients on immunosuppressive therapy.
    • Patients with their last SARS-CoV-2 vaccination at least 3 weeks prior to inclusion.
    • Patients with no or impaired humoral immune response (SARS-CoV-2 Spike RBD antibody level <2000 BAU/mL) at least 3 weeks after the last dose of SARS-CoV-2 vaccine.
    • Not participating in therapeutical intervention studies, within the last 30 days.
    • Adult patients (≥18 years).
    E.4Principal exclusion criteria
    • Women who are breastfeeding, pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (not acceptable methods: progesterone-only oral hormonal contraception, male/female condom without spermicide or cap, diaphragm or sponge with spermicide).
    • Sensitivity or intolerance to any study drug excipients.
    • Acute febrile illness or acute infection.
    • Prior receipt of any monoclonal antibodies or convalescence plasma against COVID19 (licensed or investigational) < 6 months before enrolment.
    • Administration of immunoglobulins ≤90 days before enrolment.
    • Allergic reaction to previous administrations of monoclonal antibodies.
    • Triple anticoagulation therapy.
    • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
    • Received any vaccination against other infectious diseases within the last four weeks prior to study drug administration.
    • Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to randomization.
    • Patients that the doctor considers to be unsuitable due to, for example, mental condition or abuse.
    E.5 End points
    E.5.1Primary end point(s)
    AZD 7442 serum concentrations (µg/mL).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Concentrations measured pre-dose (and 10-60 minutes after end of IV-infusion) and then weekly the first month and then after 3 and 6 months (pre-dose), or before the second dose if it is given before 6 months, after each dose. In addition, a 9- and 12-month samples is also to be obtained following the last dose in the study for all patients.
    E.5.2Secondary end point(s)
    1. Absolute intramuscular bioavailability of AZD7442
    2. Local and systemic adverse events.
    3. Neutralizing capacity of patient serum samples
    4. Number of patients with AZD7442 serum levels <19.9 μg/mL +IgG1 SARS-CoV-spike protein antibodies.
    5. SARS-CoV-2 infection assessed by anamnestic patient history (including positive PCR test)
    6. Severe COVID-19 caused by SARS-CoV-2 variants of concern (VOC), characterized by a minimum of either pneumonia or hypoxemia and a WHO Clinical Progression Scale Score of 5 or higher
    7. Hospitalization or death from COVID-19
    8. Acute rejection episodes.
    9. Cellular immune response to SARS-CoV-2 VOC.
    10. Humoral and cellular immune response to additional SARS-CoV-2 vaccination in patients on AZD7442 treatment (additional vaccination is not a study intervention, response rates will be compared to patients not receiving AZD7442 [results from the CEPI study]).
    11. Pharmacokinetic interactions with immunosuppressive drugs based on 3-point AUC estimations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. End of study
    2. Week 1 after dosing and every 3 months
    3. weekly the first month and then after 3 and 6 months (pre-dose), or before the second dose if it is given before 6 months, after each dose. In addition, a 9- and 12-month samples is also to be obtained following the last dose in the study for all patients.
    4. weekly the first month and then after 3 and 6 months (pre-dose), or before the second dose if it is given before 6 months, after each dose. In addition, a 9- and 12-month samples is also to be obtained following the last dose in the study for all patients.
    5. Every third month
    6. Every third month
    7. Every third month
    8. Every third month
    9. Month 3
    10. 4 weeks after vaccine booster dose.
    11. End of study
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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) 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.8.5The 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 No
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 No
    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 state200
    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)
    Standard treatment for kidney transplant recipients will be applied.
    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 Decision2022-11-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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