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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41472   clinical trials with a EudraCT protocol, of which   6816   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2021-000344-21
    Sponsor's Protocol Code Number:MP1032-CT05
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-01
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-000344-21
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PROOF-OF-CONCEPT, PHASE IIA STUDY OF MP1032 PLUS STANDARD OF CARE VS STANDARD OF CARE IN THE TREATMENT OF HOSPITALIZED PATIENTS WITH MODERATE TO SEVERE COVID-19.
    A SZOKÁSOS ELLÁTÁSSAL KIEGÉSZÍTETT MP1032 RANDOMIZÁLT, KETTŐS VAK, PLACEBO-KONTROLLOS, MULTICENTRIKUS, KONCEPCIÓ IGAZOLÓ IIA. FÁZISÚ VIZSGÁLATA A SZOKÁSOS ELLÁTÁSSAL SZEMBEN, A KÓRHÁZBA FELVETT, KÖZEPESEN SÚLYOS -SÚLYOS COVID-19-BEN SZENVEDŐ BETEGEK KEZELÉSE ESETÉBEN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MP1032 Treatment in Patients with Moderate to Severe COVID-19
    A.3.2Name or abbreviated title of the trial where available
    MP1032 Treatment in Patients with Moderate to Severe COVID-19
    A.4.1Sponsor's protocol code numberMP1032-CT05
    A.5.4Other Identifiers
    Name:IND number Number:153604
    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 SponsorMetrioPharm AG
    B.1.3.4CountrySwitzerland
    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 supportMetrioPharm AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMetrioPharm Deutschland GmbH
    B.5.2Functional name of contact pointClinical Department
    B.5.3 Address:
    B.5.3.1Street AddressAm Borsigturm 100
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13507
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930 338439502
    B.5.5Fax number+4930 338439599
    B.5.6E-mailclinicaltrials@metriopharm.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 nameMP1032 hard gelatin capsules 50 mg
    D.3.2Product code MP1032
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 20666-12-0
    D.3.9.2Current sponsor codeMP1032
    D.3.9.3Other descriptive nameMP 1032
    D.3.9.4EV Substance CodeSUB175038
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboCapsule, hard
    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
    Moderate to severe coronavirus disease 2019 (COVID 19)
    E.1.1.1Medical condition in easily understood language
    Moderate to severe coronavirus disease 2019 (COVID 19)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084382
    E.1.2Term Coronavirus disease 2019
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084529
    E.1.2Term 2019 novel coronavirus 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
    The primary objective of this study is to measure the effect of MP1032 plus standard of care (SoC) versus placebo plus SoC on Day 14 on disease progression in patients with moderate to severe coronavirus disease 2019 (COVID-19)
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:

    • To measure the effect of MP1032 plus SoC versus placebo plus SoC on Day 28 on disease progression in patients with moderate to severe COVID-19;
    • To measure the effect of MP1032 plus SoC versus placebo plus SoC on disease resolution on Day 14 and Day 28;
    • To measure the effect of MP1032 plus SoC versus placebo plus SoC on the mortality rate and other specific COVID-19 related characteristics;
    • To assess the safety of MP1032 (eg, adverse events [AEs] and laboratory abnormalities);
    • To assess the pharmacokinetics (PK) of MP1032 on Day 1 (single dose) and Day 7 (steady state) in a PK subset of patients.

    The exploratory objectives of this study are:

    • To measure the effect of MP1032 plus SoC versus placebo plus SoC on some additional COVID-19 related characteristics;
    • To evaluate the health-related quality of life (HRQoL) of patients treated MP1032 plus SoC compared with placebo plus SoC;
    • To evaluate biomarker levels.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional pharmacokinetik assessments
    E.3Principal inclusion criteria
    1. The patient must be willing and able to give informed consent to participate in the study and to adhere to the procedures stated in the protocol or, for adults incapable of consenting due to their medical condition (eg, too weak or debilitated, severe shortness of breath) or due to literacy issues, the patient’s legally authorized representative must be willing and able to give informed consent on behalf of the patient to participate in the study as permitted by local regulatory authorities, institutional review boards (IRBs)/independent ethics committees (IECs), or local laws;
    2. The patient is male or female adult aged ≥18 years (as per local laws) at the time of giving informed consent;
    3. The patient is admitted to a hospital and has a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test. Please note: If the patient has a previous confirmation of SARS-CoV-2 (within 7 days of Day 1), the SARS-CoV-2 test at screening is not required;
    4. The patient has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19 on Day 1, such as presence of fever (≥38.0°C [≥100.4°F] by any route), loss of smell or taste, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath upon exertion and/or at rest, or respiratory distress;
    5. The patient has the presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID-19 on Day 1:
    a) Moderate:
    i. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥20 breaths per minute, SpO2 >93% (on room air at sea level, if possible), heart rate ≥90 beats per minute
    ii. No clinical signs indicative of severe or critical COVID-19
    b) Severe:
    i. Clinical signs suggestive of severe systemic illness with COVID-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% (on room air at sea level, if possible), partial pressure of oxygen/FiO2 <300, or diagnosed with acute respiratory distress syndrome (according to the Berlin definition)
    ii. No criteria met for critical COVID-19
    6. The patient does not require hemodialysis (chronic) or any renal replacement therapies at screening or Day 1;
    7. The patient is able to swallow the study drug (hard gelatin capsules);
    8. The patient agrees to minimize strong sun exposure (sunbathing) and strong ultraviolet exposure during the course of the study. Additionally, during the study, patients must agree to use sunscreen when spending an extended period outdoors;
    9. Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication:
    a) Vasectomy with documentation of azoospermia.
    b) Sexual abstinence (defined as refraining from heterosexual intercourse from the time of first dose of study medication until at least 30 days after the last dose of study medication)
    c) Male condom plus partner use of 1 of the contraceptive options below: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches.
    10. WOCBP must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication:
    a) Sexual abstinence (defined as refraining from heterosexual intercourse from the time of first dose of study medication until at least 30 days after the last dose of study medication)
    b) Use of 1 of the contraceptive options below plus use of a condom by male partner: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches.
    c) Vasectomy of male partner with documentation of azoospermia.

    E.4Principal exclusion criteria
    1. The patient, in the opinion of the investigator, is not likely to survive for ≥48 hours beyond Day 1.
    2. The patient has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1.
    a) Asymptomatic COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test but not experiencing symptoms.
    b) Mild COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing symptoms of mild illness but no clinical signs indicative of moderate, severe, or critical COVID-19.
    c) Critical COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing at least 1 of the following: shock defined by systolic blood pressure <90 mm Hg or diastolic blood pressure <60 mm Hg, or requiring vasopressors; respiratory failure requiring endotracheal intubation and invasive mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation), and/or multi-organ dysfunction/failure.
    3. The patient has a Child Pugh score ≥ C.
    4. The patient has a documented medical history of infection with hepatitis A, B, or C at screening or Day 1.
    5. The patient has a documented medical history of infection with human immunodeficiency virus and has a detectable viral load and CD4 count <500 cells/μL.
    6. The patient has a documented active infection with tuberculosis at screening or Day 1.
    7. The patient has clinically significant electrocardiogram abnormalities at screening.
    8. A female patient who is pregnant, planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening (by serum) and before dosing on Day 1 (by urine) as determined by human chorionic gonadotrophin tests.
    9. The patient is planning to donate or bank ova or sperm from Day 1 until 30 days after the last dose of study drug.
    10. The patient has a known history of drug or alcohol abuse within 6 months of study start that would interfere with the patient’s participation in the study.
    11. The patient has a history of sensitivity to any of the study medications, components thereof (eg, mannitol or gelatin), or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation.
    12. The patient has participated in and/or plans to participate in another clinical study using an investigational product within the following period before the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
    13. The patient will be transferred to another hospital that is not a study site within 72 hours. Please note: If the investigator has admitting privileges to the transfer hospital, the patient may be considered for randomization.
    14. The patient is employed by MetrioPharm, the contract research organization or clinical site involved in the clinical study.
    15. The investigator makes a decision that study involvement is not in patient’s best interest, or the patient has any condition, in the opinion of the investigator, that will not allow the protocol to be followed safely.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is the proportion of patients with disease progression on Day 14. Disease progression is defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as patients who have a score of 2, 3, or 4 on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints of this study are:

    • Proportion of patients with disease progression on Day 28. Disease progression is defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as patients who have a score of 2, 3, or 4 on the NIAID 8-point ordinal scale.
    • Proportion of patients with disease resolution on Day 28. Disease resolution is defined as patients who are alive and have a score of 6, 7, or 8 on the NIAID 8-point ordinal scale.
    • All-cause mortality rate at Day 28
    • Change of clinical status related to COVID-19 on Day 28 compared with baseline according to the following NIAID 8-point ordinal scale:
    1. Death;
    2. Hospitalized, on invasive ventilation (mechanical ventilator and/or extracorporeal membrane oxygenation [ECMO]);
    3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise);
    6. Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons);
    7. Not hospitalized, limitation on activities, and/or requiring home oxygen;
    8. Not hospitalized, no limitations on activities.

    The other secondary endpoints of this study are:

    • Proportion of patients with disease resolution on Day 14. Disease resolution is defined as patients who are alive and have a score of 6, 7, or 8 on the NIAID 8-point ordinal scale.
    • All-cause mortality rate at Day 14 and Day 60
    • Change of clinical status related to COVID-19 on Day 14 compared with baseline according to the NIAID 8-point ordinal scale as listed above.
    • Proportion of patients requiring invasive ventilation (mechanical ventilator and/or ECMO), or who are not alive on Day 14 or Day 28
    • Proportion of patients in each category of the NIAID 8-point ordinal scale
    • Time to (first) improvement of at least 1 category on the NIAID 8-point ordinal scale (until Day 28). Patients who did not improve at least 1 category on the NIAID scale or die before Day 28 will be censored at Day 28.
    • The odds ratio between MP1032 and SoC and placebo and SoC for the number of patients with clinical status improvement from baseline on the NIAID 8-point ordinal scale (ie, an improvement of at least 1 category) at Day 14 and Day 28
    • Total duration of hospitalization on Day 28 and Day 60 (from baseline to discharge; with death censored on the last day of the observed period – at Day 28 or Day 60, respectively)
    • Proportion of patients alive and testing negative for COVID-19 on Day 14, Day 28, and Day 60
    • Safety and tolerability assessed by:
    o Cumulative incidence of treatment-emergent AEs (summarized by seriousness, severity, relationship to the study medication, outcome, and duration)
    o Vital sign parameters
    o Clinical laboratory parameters
    o Physical examination findings
    • MP1032 plasma concentrations and PK parameters (if possible) including maximum observed plasma concentration, area under the concentration-time curve, elimination parameters, apparent body clearance, apparent volume of distribution, trough concentration, average observed plasma concentration at steady state, and other relevant PK parameters assessed via MP1032 plasma exposure on Day 1 and Day 7 in a PK subset of patients

    Exploratory endpoints of this study are:

    • Change in saturation of oxygen (SpO2)/fraction of inspired oxygen (FiO2) ratio (for patients alive) on Day 14 or Day 28 compared with baseline
    • Total number of days in the intensive care unit (ICU)
    • Duration of invasive mechanical ventilation
    • Duration of ECMO
    • Change in COVID-19 symptoms (stuffy or runny nose, sore throat, red or irritated eyes, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, and number of times of vomit, times of diarrhea, sense of smell, sense of taste in the last 24 hours) at Day 14, Day 28, and Day 60
    • Change from discharge in the EuroQol (EQ) index value and EQ visual analog scale (VAS) based on the EuroQol-5D-5L (EQ-5D-5L) questionnaire at Day 60
    • Change from baseline in biomarker levels potentially including, but not limited to, cytokines (eg, C-reactive protein, interleukin [IL]-1β, IL-6, tumor necrosis factor-α, and interferon-γ), oxidative stress biomarkers (eg, malondialdehyde), and other coagulation/inflammatory biomarkers (eg, D-dimer and ferritin)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As specified within the list of endpoints
    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 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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Proof of concept
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Belgium
    Bulgaria
    Czechia
    France
    Hungary
    Italy
    Mexico
    Poland
    Romania
    Spain
    United States
    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
    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 months5
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days9
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Hospitalized patients with moderate to severe coronavirus disease 2019 (COVID-19) will be enrolled: there is a possibility to enroll adults incapable of consenting due to their medical condition or due to literacy issues.
    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 90
    F.4.2.2In the whole clinical trial 120
    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 Decision2021-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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