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    The EU Clinical Trials Register currently displays   43875   clinical trials with a EudraCT protocol, of which   7295   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:2020-002029-28
    Sponsor's Protocol Code Number:RC20_0191
    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:2020-04-24
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-002029-28
    A.3Full title of the trial
    Doxycycline Versus Placebo in COVID-19 + Patients without hospitalization criteria:
    Prospective, multicenter, randomized, double-blind, prospective study.
    Doxycycline Versus Placebo chez des Patients COVID-19 + sans critère d’hospitalisation :
    Etude prospective, multicentrique, randomisée en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Doxycycline Versus Placebo in COVID-19 + Patients without hospitalization criteria:
    Prospective, multicenter, randomized, double-blind, prospective study.
    A.3.2Name or abbreviated title of the trial where available
    DYNAMIC
    A.4.1Sponsor's protocol code numberRC20_0191
    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 SponsorCHU Nantes
    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 supportPierre Fabre
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCHU de Nantes
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportLaboratoire Bailleul
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportNantes métropole
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportFondation grand Ouest Banque populaire
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Nantes
    B.5.2Functional name of contact pointDirection Recherche Innovation
    B.5.3 Address:
    B.5.3.1Street Address5 allée de l'ile Gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number00332 40 08 49 84
    B.5.5Fax number00332 53 48 28 36
    B.5.6E-mailbp-prom-regl@chu-nantes.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 Yes
    D.2.1.1.1Trade name Granudoxy 100mg
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameGranudoxy
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 disease
    E.1.1.1Medical condition in easily understood language
    Patients COVID-19 + without hospitalization criteria
    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 10070267
    E.1.2Term SARS virus test positive
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Decrease the percentage of patients requiring hospitalization for COVID-19 infection, after at least 48 hours of treatment.
    Decrease the percentage of patients requiring mechanical ventilatory support.
    Diminuer le pourcentage des patients nécessitant une hospitalisation en rapport avec l’infection à COVID-19 près au moins 48 heures de traitement expérimental.
    Diminuer le pourcentage de patients nécessitant une assistance ventilatoire mécanique.
    E.2.2Secondary objectives of the trial
    - Decrease the percentage of patients with positive PCR SARS-CoV-2 at D7 (+/- 2 days) after the start of experimental treatment.
    - Decrease the total length of hospital stay
    - Decrease the length of hospitalization in intensive care or intensive care unit
    - Decrease the duration of mechanical ventilatory assistance
    - Decrease the number of deaths related to SARS-CoV-2 infection
    - Assessing the safety / tolerance of doxycycline
    - Identifying the characteristics of doxycycline-responsive patients
    - Diminuer le pourcentage de patients avec PCR SARS-CoV-2 positive à J7 (+/- 2 jours) après le début du traitement expérimental
    - Diminuer la durée totale d'hospitalisation
    - Diminuer la durée d'hospitalisation en soins intensifs ou en service de réanimation
    - Diminuer la durée de l'assistance ventilatoire mécanique
    - Diminuer le nombre de décès en rapport avec l’infection à SARS-CoV-2
    - Evaluer la sécurité / tolérance de la doxycycline
    - Identifier les caractéristiques des patients répondeurs à la doxycycline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient who has signed informed consent
    - Man or woman over 45 years of age.
    - Patient with SARS-CoV-2 positive PCR (sample less than 48h old)
    - Symptomatic patient, having at least one of the following symptoms without hospitalisation criteria :
    General symptoms: fever, headache, asthenia
    ENT symptoms: sore throat, rhinorrhea
    Respiratory symptoms: dyspnoea, breathing rate > 22/min,
    Digestive symptoms: nausea, vomiting, diarrhoea
    - Patient with at least one of the following risk factors for adverse events:
    ≥ 70 years of age, BMI > 30, cardiovascular history (stroke, coronary artery disease, complicated hypertension, cardiac surgery, NYHA III or IV heart failure), respiratory pathology likely to decompensate with viral infection, respiratory failure, poorly controlled and/or complicated diabetes, patients with chronic renal failure on dialysis, cancer patients under treatment
    - Patient with social security
    - Patient ayant signé son consentement éclairé
    - Homme ou femme de plus de 45 ans.
    - Patient ayant une PCR positive au SARS-CoV-2 (prélèvement datant de moins de 48h)
    - Patient symptomatique, ayant au moins un des symptômes suivant sans critère d’hospitalisation :
    Symptômes généraux : fièvre, céphalée, asthénie
    Symptômes ORL : maux de gorge, rhinorrhée
    Symptômes respiratoires : dyspnée, fréquence respiratoire > 22/min,
    Symptômes digestifs : nausée, vomissement, diarrhée
    - Patient ayant au moins un facteur de risque d’évolution défavorable parmi les suivants :
    ≥ 70 ans, IMC > 30, antécédents cardiovasculaires (AVC, coronaropathie, HTA compliquée, chirurgie cardiaque, insuffisance cardiaque NYHA III ou IV), pathologie respiratoire susceptible de décompenser lors de l’infection virale, insuffisance respiratoire, diabète mal équilibré et/ou compliqué, patients présentant une insuffisance rénale chronique dialysée ,patients atteints de cancer sous traitement
    -Patient affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Lactose intolerant patient
    -Patient requiring immediate hospitalisation for any medical reason
    - Patient with more than 5 days of clinical signs at inclusion visit
    - Patient asymptomatic or with isolated anosmia
    - Patient with history of doxycycline or tetracycline allergy or one of the excipients of the speciality GRANUDOXY 100 mg tablet
    - Patient with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases) due to the presence of lactose in the experimental treatment.
    - Patient with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary diseases) due to the presence of sucrose in the experimental treatment.
    - Pregnant or breastfeeding woman
    - Patient participating in another clinical trial
    - Patient having a photosensitive skin pathology
    - Patient treated with oral anticoagulant
    - Patient treated with oral retinoids: isotretinoin, alitretinoin, acitretinoin
    - Patient treated with vitamin A
    - Patient treated with systemic antibiotic for the duration of treatment
    - Patient treated with barbiturates, carbamazepine or phenytoin or fosphenytoin
    - Patient with treatment that may affect CoV2-SARS infection: chloroquine, hydroxychloroquine, remdesivir, ganciclovir, acyclovir, ribavirin, lopinavir/ritonavir.
    - Patient under guardianship or trusteeship or in safeguard of justice
    -Patient intolérant au lactose
    -Patient justifiant d’une hospitalisation immédiate quel que soit le motif médical
    - Patient ayant plus de 5 jours de signes cliniques à la visite d’inclusion
    - Patient asymptomatique ou avec une anosmie isolé
    - Patient avec antécédents d'allergie à la doxycycline ou aux tétracyclines ou à l’un des excipients de la spécialité GRANUDOXY 100 mg comprimé pelliculé sécable
    - Patient présentant une intolérance au galactose, un déficit en lactase de Lapp ou un syndrome de malabsorption du glucose ou du galactose (maladies héréditaires rares) en raison de la présence de lactose dans le traitement expérimental
    - Patient présentant une intolérance au fructose, un syndrome de malabsorption du glucose et du galactose ou un déficit en sucrase/isomaltase (maladies héréditaires rares) en raison de la présence de saccharose dans le traitement expérimental
    - Femme enceinte ou allaitante
    - Patient participant à un autre essai clinique
    - Patient ayant une pathologie cutanée photosensible
    - Patient traité par anticoagulant oraux
    - Patient traité par rétinoïdes oraux : isotrétinoine, alitrétinoine, acitrétine
    - Patient traité par vitamine A
    - Patient traité par antibiotique systémique pendant la durée du traitement
    - Patient traité par barbituriques, carbamazépine ou phénytoïne ou fosphénytoine
    - Patient avec un traitement pouvant avoir un effet sur l’infection à SARS-CoV2 : chloroquine, hydroxychloroquine, remdesivir, ganciclovir, acyclovir, ribavirine, lopinavir/ritonavir
    - Patient sous tutelle ou curatelle ou en sauvegarde de justice
    E.5 End points
    E.5.1Primary end point(s)
    Criteria corresponding to the main objective
    o Percentage of patients hospitalized for COVID-19 after at least 48 hours of experimental treatment
    - Criterion corresponding to the second main objective nested :
    o Percentage of patients requiring mechanical ventilatory assistance
    Critères correspondant à l’objectif principal :
    o Pourcentage de patients hospitalisés pour le COVID-19 après au moins 48 heures de traitement expérimental
    - Critère correspondant au deuxième objectif principal emboîté :
    o Pourcentage de patients nécessitant une assistance ventilatoire mécanique
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    - Number of positive SARS-CoV-2 PCR tests at D-1/D0 and D7 (+/- 2 days)
    - Total length of hospital stay
    - Total length of hospital stay in intensive care or intensive care unit
    - Duration of mechanical ventilatory assistance
    - Number of deaths related to SARS-CoV-2 infection
    - Number of EI/EIG in both arms
    - Characteristics of doxycycline responders: sex, age, number and type of severity criteria, serology.
    - Nombre de tests PCR SARS-CoV-2 positifs à J-1/J0 et à J7 (+/- 2 jours)
    - Durée totale d'hospitalisation
    - Durée totale d'hospitalisation en soins intensifs ou en service de réanimation
    - Durée de l'assistance ventilatoire mécanique
    - Nombre de décès en rapport avec l’infection à SARS-CoV-2
    - Nombre d’EI/EIG dans les deux bras
    - Caractéristiques des répondeurs à la doxycycline : sexe, âge, nombre et type de critères de gravités, sérologie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 28
    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 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) No
    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 trial2
    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 concerned6
    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 years
    E.8.9.1In the Member State concerned months7
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-24. Yes
    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 state330
    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 Decision2021-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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