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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2020-001686-36
    Sponsor's Protocol Code Number:2020-21
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-001686-36
    A.3Full title of the trial
    A double-blind, randomized study versus placebo of avdoralimab (IPH5401), an anti-C5aR antibody, in patients with COVID-19 induced pneumonia
    Etude clinique en double aveugle, randomisée versus placebo évaluant avdoralimab (IPH5401) anticorps anti-C5aR dans les pneumonies sévères induites par COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, randomized study versus placebo of avdoralimab (IPH5401), an anti-C5aR antibody, in patients with COVID-19 induced pneumonia
    Etude clinique en double aveugle, randomisée versus placebo évaluant avdoralimab (IPH5401) anticorps anti-C5aR dans les pneumonies sévères induites par COVID-19
    A.3.2Name or abbreviated title of the trial where available
    FORCE (FOR COVID-19 Elimination)
    A.4.1Sponsor's protocol code number2020-21
    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 SponsorASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    B.1.3.4CountryFrance
    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 supportAPHM
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationaphm
    B.5.2Functional name of contact pointDirection de la Recherche Santé
    B.5.3 Address:
    B.5.3.1Street Address80 rue Brochier
    B.5.3.2Town/ cityMarseille
    B.5.3.3Post code13354 cedex 05
    B.5.3.4CountryFrance
    B.5.4Telephone number04 91 38 27 47
    B.5.5Fax number04 91 38 14 79
    B.5.6E-mailpromotion.interne@ap-hm.fr
    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 nameavdoralimab
    D.3.2Product code IPH5401
    D.3.4Pharmaceutical form Powder for 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 INNavdoralimab
    D.3.9.1CAS number 2226393-85-5
    D.3.9.2Current sponsor codeIPH5401
    D.3.9.3Other descriptive nameNNC0215-0384
    D.3.9.4EV Substance CodeSUB33404
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for 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 infection
    Coronavirus infection
    E.1.1.1Medical condition in easily understood language
    Coronavirus infection
    Coronavirus infection
    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 LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -Cohort 1: Evaluate the clinical improvement of patients on the basis of the WHO scale (Ordinal Scale for Clinical Improvement - Annex) calculated on D14 and D28
    -Cohort 2 (COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in intensive care unit): Number of days living without mechanical ventilation at D28 (Ventilator-free days or VFD28) (avdoralimab patients vs placebo patients)
    - Cohort 3: Evaluate the clinical improvement of patients on the basis of the WHO scale calculated on D14 and D28
    -Pour la Cohorte 1 : Evaluer l’amélioration clinique des patients sur la base de l’échelle de l’OMS (Ordinal Scale for Clinical Improvement – Annexe) calculée à J14 et J28
    -Pour la cohorte 2 : Evaluer le nombre de jours vivant sans ventilation mécanique à J28 (Ventilator-free days ou VFD28) chez les patients traités par avdoralimab versus placebo
    Cohorte 3 : Evaluer l’amélioration clinique des patients sur la base de l’échelle de l’OMS calculée à J14 et J28
    E.2.2Secondary objectives of the trial
    -Evaluate the improvement in the rate of patients discharged alive from hospital on D14
    - WHO scale at D14 and at D28
    - Evaluate the clinical improvement in patients based on the WHO scale calculated on D14 and D28 (cohort 2)
    -Evaluate the decrease of the number of patients transferred to intensive care (cohort 1)
    -Evaluate the decrease of hospital stay duration
    -Evaluate the decrease of intensive care unit hospitalization duration
    -Evaluate the number of days living without mechanical ventilation at D14 (VFD14) and at D28 (VDF28)for patients hospitalized in intensive care unit
    -Evaluate the decrease of mortality at D28
    -Evaluate the improvement of the SOFA (organ failure) score of patients at D14 for patients hospitalized in intensive care unit
    -Evaluate the number of sepsis (SEPSIS-3 definition)
    -Evaluate avdoralimab safety
    - Evaluer l’amélioration du taux de patients sortis vivant d’hôpital à J14
    - Echelle de l’OMS à J14 et à J28
    - Evaluer l’amélioration clinique des patients sur la base de l’échelle de l’OMS calculée à J14 et J28 (cohorte 2)
    -Evaluer la réduction du nombre d’admissions en réanimation (cohorte 1)
    -Evaluer la réduction de la durée de séjour hospitalier
    -Evaluer la réduction de la durée de séjour en réanimation
    -Evaluer l’augmentation du nombre de jours vivant sans ventilation à J14 (VFD14) et VDF28 pour les malades de réanimation
    -Evaluer la réduction la mortalité à J28
    -Evaluer l’amélioration du score SOFA (défaillances d’organe) des patients à J14 pour les patients de réanimation
    -Evaluer le nombre de sepsis (définition SEPSIS-3)
    -Evaluer la tolérance à avdoralimab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    *patient over 18 years of age
    *Patient under 80 years of age
    *COVID-19 hypoxemic pneumonia (cohort 1)defined by :
    o Need for oxygen therapy ≥ 5 l/min to maintain SpO2 > 93%(conventional oxygen therapy and / or high flow oxygen therapy)
    o PCR SARS-CoV-2 positive
    *For patients immediately included in intensive care : (cohort 2)
    o Patient under mechanical invasive ventilation with a PaO2/FiO2 ratio < 300 for more than 24 hours.
    o PCR SARS-CoV-2 positive and / or chest scanner in favor of the diagnosis of COVID-19
    Pour les patients inclus d’emblée en réanimation (cohort3):
    - Patient sous ventilation mécanique invasive depuis moins de 72h et avec un rapport PaO2/FiO2 inférieur ou égal à 200 et supérieur ou égal à 60 au moment de la randomisation
    - PCR SARS-CoV-2 positive

    *Patient majeur de plus de 18 ans
    Patient de moins de 80 ans révolus
    *Pneumonie hypoxémiante à COVID-19 (cohorte 1) définie par :
    -Besoin d’une oxygénothérapie ≥ 5 l/mn pour maintenir une SpO2 > 93% (oxygénothérapie conventionnelle et/ou oxygénothérapie à haut débit)
    - PCR SARS-CoV-2 positive
    *Pour les patients inclus d’emblée en réanimation : (cohorte 2)
    - Patient sous ventilation mécanique invasive, non invasive ou oxygénothérapie à haut débit avec un rapport PaO2/FiO2 < 300 pendant plus de 24h
    - PCR SARS-CoV-2 positive et/ou scanner thoracique en faveur du diagnostic de COVID-19
    Pour les patients inclus d’emblée en réanimation (cohorte3):
    - Patient sous ventilation mécanique invasive depuis moins de 72h et avec un rapport PaO2/FiO2 inférieur ou égal à 200 et supérieur ou égal à 60 au moment de la randomisation
    - PCR SARS-CoV-2 positive

    E.4Principal exclusion criteria
    -Pregnant or breastfeeding woman
    -Patient deprived of liberty
    -Patient refusal to participate in the study
    -Patient already included in another clinical trial or within 2 weeks prior to randomization
    -Patient for whom measures of therapeutic limitations have been issued for non-admission to intensive care units
    - Uncontrolled sepsis of bacterial or fungal origin
    Additional non-inclusion criteria for cohort 1:
    - Patients who have already been treated with high flow oxygen therapy and / or non-invasive ventilation if the patient is included on conventional oxygen therapy
    - Patient who received invasive mechanical ventilation prior to randomization
    Additional non-inclusion criteria for cohort 3:
    - Patients under invasive mechanical ventilation for more than 72 hours
    - Patients on ECMO at the time of randomization
    Additional non-inclusion criteria for cohorts 1 and 3
    -Treatment with chloroquine or hydroxychloroquine at the time of randomization
    - Patient decompensating a chronic pulmonary pathology: asthma, COPD, cystic fibrosis
    - Chronic dialysis patients or justifying extra-renal purification at the time of randomization
    - Organ transplants within 3 months prior to randomization
    - Patient with NYHA stage III-IV chronic congestive heart failure
    - Cirrhotic patients Child B-C
    - Patients who presented with cardiac arrest within 2 weeks prior to randomization
    -Femme enceinte ou allaitante
    -Patient privé de liberté
    -Refus du patient de participer à l’étude
    -Patient déjà inclus dans un autre essai thérapeutique ou dans les 2 semaines qui précèdent la randomisation
    -Patient pour lequel ont été émises des mesures de limitations thérapeutiques à type de non-admission en réanimation
    -Sepsis d’origine bactérienne ou fungique non contrôlé
    Critères de non-inclusion suppélmentaires pour la cohorte 1 :
    - Patients ayant déjà été pris en charge par oxygénothérapie à haut débit et/ou ventilation non invasive si le patient est inclus sous oxygénothérapie conventionnelle
    - Patient ayant reçu une ventilation mécanique invasive préalable à la randomisation
    Pour les patients inclus d’emblée en réanimation (cohorte3):
    - Patients sous ventilation mécanique invasive depuis plus de 72h
    - Patients sous ECMO au moment de la randomisation
    Critères de non-inclusion suppélmentaires pour les cohortes 1 et 3
    - Traitement par chloroquine ou hydroxychloroquine au moment de la randomisation
    - Patient décompensant une pathologie pulmonaire chronique : asthme, BPCO, mucoviscidose
    - Patients dialysés chroniques ou justifiant d’une épuration extra-rénale au moment de la randomisation
    - Transplantés d’organe dans les 3 mois précédant la randomisation
    - Patient atteints d’une insuffisance cardiaque chronique congestive stade III-IV de la NYHA
    - Patients cirrhotiques Child B-C
    - Patients ayant présenté un arrêt cardiaque dans les 2 semaines précédant la randomisation

    E.5 End points
    E.5.1Primary end point(s)
    -Cohort 1: Clinical improvement on the WHO scale on D14 and D28 Difference between experimental arm and control arm
    - Cohort 2: Number of days living without mechanical ventilation on D28 (Ventilator-free days or VFD28) Difference between experimental arm and control arm
    - Cohort 3: Clinical improvement on the WHO scale on D14 and D28 Difference between experimental arm and control arm
    - Cohorte 1 : Amélioration clinique sur l’échelle de l’OMS à J14 et à J28 Difference entre bras experimental et bras contrôle
    - Cohorte 2 : Nombre de jours vivant sans ventilation mécanique à J28 (Ventilator-free days ou VFD28) Difference entre bras experimental et
    bras contrôle
    - Cohorte 3 : Amélioration clinique sur l’échelle de l’OMS à J14 et à J28 Difference entre bras experimental et bras contrôle
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cohort 1 : Day 14 and Day 28
    Cohort 2: Day 28
    Cohort 3: Day 14 and Day 28
    Cohorte 1 : J 14 ET J28
    Cohorte 2: J 28
    Cohorte 3 : J14 ET J28
    E.5.2Secondary end point(s)
    -Clinical respiratory score at Day 14 and Day 28
    -VFD14 for patients hospitalized in intensive care unit
    -Admission rate in intensive care units
    -Mortality at D28
    -Hospital stay duration
    -Intensive care unit hospitalization duration
    -SOFA (organ failure) score at D14 for patients hospitalized in intensive care unit
    -Number of sepsis (SEPSIS-3 definition) in experimental arms
    -Adverse events number for avdoralimab patients vs placebo patients
    - Score clinique de gravité respiratoire à J14 et à J28
    - VFD14 pour les patients de réanimation
    - Taux d’admissions en réanimation
    - Mortalité à J28
    - Durée du séjour hospitalier
    - Durée du séjour en réanimation
    - Score SOFA à J14 pour les patients de réanimation
    - Nombre de sepsis (définition SEPSIS-3) dans les bras expérimentaux
    - Nombre d’évènements indésirables entre les patients traités par le placébo et les patients traités par avdoralimab
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Day 14: Clinical respiratory score; VFD14; SOFA (organ failure) score;
    -Day 28: Clinical respiratory score; Mortality
    -Throughout the duration of the study: Admission rate in intensive care units; Hospital stay duration; Intensive care unit hospitalization duration; Number of sepsis (SEPSIS-3 definition); Adverse events
    -Day 14: Clinical respiratory score; VFD14; SOFA (organ failure) score;
    -Day 28: Clinical respiratory score; Mortality
    -Throughout the duration of the study: Admission rate in intensive care units; Hospital stay duration; Intensive care unit hospitalization duration; Number of sepsis (SEPSIS-3 definition); Adverse events
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial6
    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 concerned19
    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
    Duration of hospitalisation (Patients hospitalised for a COVID-19 related pneumonia) for the last included patient.
    durée du séjour à l’hôpital (prise en charge pour une pneumonie dans le cadre du COVID-19) pour le dernier patient inclus
    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 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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 Information not present in EudraCT
    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
    Patients in intensive care unit
    Patients en réanimation
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state168
    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)
    It is expected that IPH5401 will only be administered during trial participation. Standard care for these patients is expected after their participation to the trial, according to local practices.
    IPH5401 ne sera administré que dans le cadre du présent essai clinique. Les patients seront suivi selon les pratiques standard après leur participation à l'étude.
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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