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    Summary
    EudraCT Number:2020-005887-70
    Sponsor's Protocol Code Number:REMED
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-11
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-005887-70
    A.3Full title of the trial
    Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomized controlled trial
    Účinek dexamethasonu u pacientů s ARDS a COVID-19 – prospektivní, multicentrická, otevřená, randomizovaná kontrolovaná studie s paralelními skupinami
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomized controlled trial
    Účinek dexamethasonu u pacientů s ARDS a COVID-19 – prospektivní, multicentrická, otevřená, randomizovaná kontrolovaná studie s paralelními skupinami
    A.4.1Sponsor's protocol code numberREMED
    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 SponsorFakultní nemocnice Brno
    B.1.3.4CountryCzechia
    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 supportFakultní nemocnice Brno
    B.4.2CountryCzechia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFakultní nemocnice Brno
    B.5.2Functional name of contact pointJan Maláska
    B.5.3 Address:
    B.5.3.1Street AddressJihlavská 20
    B.5.3.2Town/ cityBrno
    B.5.3.3Post code625 00
    B.5.3.4CountryCzechia
    B.5.6E-mailmalaska.jan@fnbrno.cz
    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.2.5The 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.3.4Pharmaceutical form Solution for injection/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 INNDexamethasone sodium phosphate
    D.3.9.1CAS number 2392-39-4
    D.3.9.4EV Substance CodeSUB01615MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute respiratory distress syndrome (ARDS) associated with COVID-19 pneumonia
    Syndrom akutní dechové tísně (ARDS) spojený s COVID-19 pneumonií
    E.1.1.1Medical condition in easily understood language
    Acute respiratory distress syndrome (ARDS) associated with COVID-19 pneumonia
    Syndrom akutní dechové tísně (ARDS) spojený s COVID-19 pneumonií
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior over 6 mg in adult patients with moderate or severe ARDS due to confirmed COVID-19.
    Primárním cílem této studie je otestovat hypotézu, jestli je podávání 20 mg dexamethasonu denně lepší než podávání 6 mg dexamethasonu denně u dospělých pacientů se středním nebo závažným ARDS v souvislosti s COVID-19.
    E.2.2Secondary objectives of the trial
    The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg.

    The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.
    Sekundárním cílem je prozkoumat účinnost a bezpečnost dávky 20 mg dexamethasonu v porovnání s dávkou 6 mg dexamethasonu.

    Výzkumné cíle a ukazatele: Posoudit dlouhodobé důsledky na úmrtnost a funkční omezení po 180 a 360 dnech.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult (≥ 18 years of age) at time of enrolment;
    2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing);
    3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy;
    4. Moderate or severe ARDS according to Berlin criteria:
    • Moderate – PaO2/FiO2 100–200 mmHg;
    • Severe – PaO2/FiO2 < 100 mmHg;
    5. Admission to ICU in the last 24 hours.
    1. Dospělý pacient (≥ 18 let) v době zařazení;
    2. Pozitivní nález COVID-19 (infekce potvrzená RT-PCR nebo testováním antigenu);
    3. Intubace/mechanická ventilace nebo probíhající kyslíková terapie nosní kanylou s vysokým průtokem (HFNC);
    4. Středně závažná nebo závažná forma ARDS podle berlínských kritérií
    • středně závažná forma - PaO2/FiO2 100–200 mmHg;
    • závažná forma - PaO2/FiO2 < 100 mmHg;
    5. Přijetí na JIP během posledních 24 hodin.
    E.4Principal exclusion criteria
    1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol);
    2. Fulfilled criteria for ARDS for ≥ 14 days at enrolment;
    3. Pregnancy or breastfeeding;
    4. Unwillingness to comply with contraception measurements from the enrolment to at least 1 week after the last dose of dexamethasone (sexual abstinence is considered as the adequate contraception method);
    5. End-of-life decision or patient is expected to die within next 24 hours;
    6. Decision not to intubate or ceilings of treatment in place;
    7. Immunosuppression and/or immunosuppressive drugs in medical history:
    a) Systemic immunosuppressive drugs or chemotherapy in the past 30 days;
    b) Systemic corticosteroids use before hospitalization;
    c) Corticosteroids administration (dexamethasone equal or less than 8 mg per day or other corticosteroids in equivalent dose) during the present hospital stay for COVID-19 for more than last 5 days before enrolment;
    d) Systemic corticosteroids during present hospital stay for other conditions than COVID-19 (e.g. septic shock);
    e) Dexamethasone more than 8 mg per day or other corticosteroids in equivalent dose during the present hospital stay for COVID-19 for more than one single dose;
    8. Present haematological or generalized solid malignancy;
    9. Any of contraindications of corticosteroids, e.g.
    • intractable hyperglycaemia;
    • active gastrointestinal bleeding;
    • adrenal gland disorders;
    • a presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment;
    10. Cardiac arrest before ICU admission;
    11. Participation in another interventional trial in the last 30 days.
    1. Známá alergie/přecitlivělost na dexamethason nebo pomocné látky hodnoceného léčivého přípravku (např. parabeny, benzylalkohol);
    2. Splněná kritéria ARDS po dobu ≥ 14 dnů při zařazení;
    3. Těhotenství nebo kojení;
    4. Neochota dodržovat požadavek ochrany proti početí od okamžiku zařazení do studie do uplynutí nejméně 1 týdne od podání poslední dávky dexamethasonu (za adekvátní metodu antikoncepce se považuje sexuální abstinence);
    5. Rozhodnutí na konci života nebo očekávání úmrtí pacienta během příštích 24 hodin;
    6. Rozhodnutí neintubovat pacienta nebo zastropování orgánové podpory;
    7. Imunosuprese a/nebo imunosupresiva v anamnéze:
    a) systémová imunosupresiva nebo chemoterapie za posledních 30 dnů;
    b) užívání systémových kortikosteroidů před hospitalizací;
    c) podávání kortikosteroidů (dexamethason v dávce 8 mg/den nebo nižší nebo jiný kortikosteroid v ekvivalentní dávce) během současného pobytu v nemocnici pro COVID-19 po dobu delší než posledních 5 dní před zařazením;
    d) systémové kortikosteroidy během současného pobytu v nemocnici kvůli jiným onemocněním, než je COVID-19 (např. septický šok)
    e) dexamethason v dávce vyšší než 8 mg/den nebo jiný kortikosteroid v ekvivalentní dávce během současného pobytu v nemocnici pro COVID-19, podaný víckrát než jednorázově
    8. Přítomnost hematologické nebo generalizované solidní malignity;
    9. Jakékoli kontraindikace kortikosteroidů, např.
    • nekontrolovatelná hypeglykémie
    • aktivní gastrointestinální krvácení;
    • poruchy nadledvin;
    • přítomnost superinfekce diagnostikovaná podle lokálně stanovených klinických a laboratorních kritérií bez adekvátní antimikrobiální léčby;
    10. Srdeční zástava před přijetím na JIP;
    11. Účast v jiné intervenční studii za posledních 30 dní.
    E.5 End points
    E.5.1Primary end point(s)
    Number of ventilator-free days (VFDs) at 28 days after randomization.
    Počet dnů bez plicního ventilátoru (VFD) 28 dní po randomizaci.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Den 28
    E.5.2Secondary end point(s)
    a) Mortality from any cause at 60 days after randomization;
    b) Dynamics of inflammatory marker (CRP) change from Day 1 to Day 14;
    c) WHO Clinical Progression Scale at Day 14 (range 0–10; 0 = no illness, 1–9 = increasing level of care, and 10 = death;
    d) Adverse events related to corticosteroids (new infections, new thrombotic complications) until Day 28 or hospital discharge;
    e) Independence at 90 days after randomization assessed by Barthel Index

    The exploratory objective of this study is to assess long-term consequences on mortality and quality of life (Barthel index) at 180 and 360 days.
    a) Úmrtnost z jakékoli příčiny 60 dnů po randomizaci;
    b) Dynamika změny hladiny zánětlivého markeru (CRP) od 1. dne do 14. dne;
    c) Stupnice klinické progrese WHO ve 14. den (skóre 0–10; 0 = žádná nemoc, 1–9 = rostoucí míra péče a 10 = úmrtí);
    d) Nežádoucí účinky související s kortikosteroidy (nové infekce, nové trombotické komplikace) do 28. dne nebo do propuštění z nemocnice;
    e) Samostatnost 90 dnů po randomizaci hodnocená indexem Barthelové

    Výzkumné cíle a ukazatele: Posoudit dlouhodobé důsledky na úmrtnost a funkční omezení (index Barthelové) po 180 a 360 dnech.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 60, Day 14, Day 28, Day 90, Day 180, Day 360
    Den 60, den 14, den 28, den 90, den 180, den 360
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    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 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 concerned10
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    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
    An abbreviated version for patients with reduced perception. If the patient is in a condition unable to give consent, the consent of an independent physician is required.
    Zkrácená verze pro pacienta se sníženou schopností vnímání. Pokud pacient není schopen, bude vyžadován souhlas nezávislého lékaře.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    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
    Žádná
    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 Decision2021-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-23
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