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    Summary
    EudraCT Number:2021-000613-16
    Sponsor's Protocol Code Number:CATCOVID-v1.2
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-09-08
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2021-000613-16
    A.3Full title of the trial
    CCR1 antagonist treatment in patients hospitalized with COVID-19
    A multi-centric, randomized, double-blind, and placebo-controlled clinical phase II trial
    CCR1 Antagonist Behandlung zur Therapie von hospitalisierten COVID-19 Patienten
    Eine multizentrische, randomisierte, doppelt-verblindete und Placebo-kontrollierte klinische Phase II Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CCR1 antagonist treatment in patients hospitalized with COVID-19
    A multi-centric, randomized, double-blind, and placebo-controlled clinical phase II trial
    CCR1 Antagonist Behandlung zur Therapie von hospitalisierten COVID-19 Patienten
    Eine multizentrische, randomisierte, doppelt-verblindete und Placebo-kontrollierte klinische Phase II Studie
    A.3.2Name or abbreviated title of the trial where available
    CATCOVID
    A.4.1Sponsor's protocol code numberCATCOVID-v1.2
    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 SponsorCharité – Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBMBF
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBerlin Institute of Health at Charité
    B.5.2Functional name of contact pointBIH - Center for Digital Health
    B.5.3 Address:
    B.5.3.1Street AddressKapelle-Ufer 2
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450 543131
    B.5.6E-mailbritta.seidemann@charite.de
    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 nameBAY 86-5277
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBAY 86-5277
    D.3.9.3Other descriptive name[5-chloro-2-[2-[(2R)-4-[(4-fluorophenyl)methyl]-2-methyl-piperazin-1-yl]-2-oxo-ethoxy]phenyl]urea
    D.3.9.4EV Substance CodeSUB235988
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 placeboOral liquid
    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
    Patients with acute SARS-CoV-2 infection, proven by a positive SARS-CoV-2 PCR test. The health status of the patients at inclusion in the clinical trial is rated 5 - 6 according to the WHO scale (see protocol, CATCOVID_v1.2, 27.09.2021, page 13). Patients are at high risk of severe disease progression with ARDS and/or multiple organ failure, and at high risk of mortality.
    Patienten haben eine akute SARS-CoV-2 Infektion, nachgewiesen durch einen positiven SARS-CoV-2 PCR Test. Der Gesundheitszustand der Patienten bei Einschluss in die klinische Studie wird nach der WHO Skala mit 5 - 6 bewertet (siehe Prüfplan, CATCOVID_v1.2, 27.09.2021, Seite 13). Die Patienten haben ein hohes Risiko eines schweren Krankheitsverlaufs mit ARDS und/oder Multiorganversagen sowie ein hohes Mortalitätsrisiko.
    E.1.1.1Medical condition in easily understood language
    Acute SARS-CoV-2 infection. Health status at inclusion is 5-6 (WHO scale). High risk of severe disease progression with ARDS and/or multiple organ failure; high risk of mortality
    Akute SARS-CoV-2 Infektion. Gesundheitszustand bei Studieneinschluss bei 5-6 gem. WHO Skala. Hohes Risiko eines schweren Krankheitsverlaufs mit ARDS und/od. Multiorganversagen, hohes Mortalitätsrisiko
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 overall objective of the study is to evaluate the clinical efficacy and safety of the CCR1 antagonist BAY 86-5277 in comparison to the placebo control arm of the study in patients hospitalized with COVID-19.

    The primary objective is the reduction of a critical disease progression in hospitalized COVID-19 patients with the need for oxygen supplementation. Mechanical ventilation is one of the key clinical
    features of severe COVID-19. The primary endpoint is the number of ventilator-free days during the study period of 28 days. The survey of ventilator-free days, i.e. the reduced need for mechanical ventilation, allows an assessment of whether BAY 86-5277 reduces progression to more severe courses of COVID-19.

    See protocol, CATCOVID_v1.2, 27.09.2021: Chapter 5 (Objectives and Endpoints); Subchapter 5.1, page 30.
    Das übergeordnete Ziel dieser Studie ist die Evaluation der klinischen Wirksamkeit sowie der Verträglichkeit von BAY 86-5277 in hospitalisierten COVID-19 Patienten im Vergleich zu einem Placebo.

    Das Primärziel ist die Reduktion des Risikos eines kritischen Krankheitsverlaufs bei hospitalisierten, sauerstoffpflichtigen, nicht-invasiv beatmeten COVID-19 Patienten. Als primären Endpunkt nehmen wir die Anzahl der beatmungsfreien Tage während der 28-tägigen klinischen Prüfung.

    Siehe Prüfplan, CATCOVID_v1.2, 27.09.2021: Kapitel 5 (Objectives and Endpoints); Unterkapitel 5.1, Seite 30
    E.2.2Secondary objectives of the trial
    We will monitor several clinical parameters as secondary outcomes and a detailed assessment
    of the clinical course of the COVID-19 patients. Additionally, we will monitor the pharmacokinetics in a sub-cohort during the initial phase of the clinical trial. Besides the assessment of the efficacy, we will also evaluate the safety of BAY 86-5277.
    Weitere klinische Parameter zur detaillierteren Beurteilung des klinischen Verlaufs unter BAY 86-5277- bzw. Placebo-Behandlung werden erhoben. Ferner wird die Pharmakokinetik in einer Subkohorte während der Anfangsphase der klinischen Studie überwacht. Neben der Bewertung der Wirksamkeit wird die Sicherheit von BAY 86-5277 untersucht.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetics
    Pharmacokinetics will be performed using EDTA plasma from a sub-cohort (12 patients) during the initial phase of the study. Plasma samples will be taken at a maximum of 4 days (Day 1, 2, 4, and 10). The samples will be analyzed for the total as well as the unbound drug concentrations.

    For further details, see protocol, CATCOVID_v1.2, 27.09.2021: Chapter 6 (Study Design); Subchapter 6.2.1, page 34f.
    Pharmakokinetik
    Ferner wird die Pharmakokinetik in einer Subkohorte (12 Patienten) während der Anfangsphase der klinischen Studie überwacht. EDTA-Plasmaproben werden an maximal 4 Tagen entnommen (Tag 1, 2, 4 und 10), um die gebundenen und ungebundenen Wirkstoffplasmaspiegel zu bestimmen.

    Für weitere Details, siehe Prüfplan, CATCOVID_v1.2, 27.09.2021: Kapitel 6 (Study Design); Unterkapitel 6.2.1, Seite 34f.
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a patient must meet all of the following inclusion
    criteria:

    1. Age ≥ 18 years
    2. Male or non-pregnant*/non-breast-feeding female
    3. Subject understands the clinical trial and signed the informed consent form
    4. Positive laboratory-confirmed SARS-CoV-2 PCR test
    Allergy to dexamethasone
    5. WHO clinical progression scale 5-6
    6. Onset of COVID-19 symptoms < 10 days before randomization

    *negative pregnancy test

    See protocol, CATCOVID_v1.2, 27.09.2021: Chapter 7 (Study Population); Subchapter 7.1, page 37f.
    Um an der Studie teilnehmen zu dürfen, muss der Patient alle der folgenden Kriterien erfüllen:

    1. Teilnehmer muss bei Einschluss in die klinische Studie mindestens 18 Jahre alt sein;
    2. Männliche oder nicht-schwangere* bzw. stillende weibliche Erwachsene;
    3. Einwilligungsfähige Patienten nach GCP-ICH, die die Einwilligungserklärung vor Beginn der klinischen Studie unterzeichnet haben;
    4. Es liegt ein positiver SARS-CoV-2 PCR Test vor, der die Infektion bestätigt;
    5. WHO clinical progression scale 5-6;
    6. COVID-19 Symptombeginn <10 Tage vor Randomisierung.

    *negativer Schwangerschaftstest

    Siehe Prüfplan, CATCOVID_v1.2, 29.09.2021: Kapitel 7 (Study Population); Unterkapitel 7.1, Seite 37f.
    E.4Principal exclusion criteria
    Exclusion Criteria:

    1. Patient has a chance of survival < 48 hours at time of randomization
    2. Participation in another interventional clinical trial
    3. Specific immunomodulatory treatment for COVID-19 according to the S3 living guideline for > 72 hours before randomization
    4. Other indications for systemic or inhaled glucocorticoid treatment
    5. Immunosuppressive medication within the last 30 days before randomization
    6. Immunosuppressive disease
    7. Chronic inflammatory airways disease (e.g., COPD)
    8. Renal failure requiring dialysis
    9. Acute (or acute on chronic) liver failure, Chronic liver failure (Child-Pugh class C)
    10. Chronic heart failure NYHA III/IV
    11. Acute right heart failure
    12. Clear evidence of active tuberculosis, bacterial, fungal, viral, or other infection (besides SARS-CoV-2)
    13. Current or regular treatment with Chloramphenicol*
    14. Current or regular treatment with Nefazodone*
    15. Current or regular treatment with Cimetidin*
    16. Current or regular treatment with macrolide antibiotics*
    17. Current or regular treatment with azole antimycotics*
    18. Treatment with Phenytoin**
    19. Person is placed in an institution based on an official or judicial order
    20. Person who is dependent on the Sponsor, Principal Investigators, or the study site

    *Please note that only clinically relevant strong CYP3A4 inhibitors were considered, please note that
    protease inhibitors will not be relevant for this study as patients with an immunosuppressive disease
    are excluded (see also section 8.1.4).
    ** Please note that only strong CYP3A4 inducers were considered (see also section 8.1.4)

    See protocol, CATCOVID_v1.2, 27.09.2021: Chapter 7 (Study Population); Subchapter 7.1, page 37f.
    Die folgenden Ausschlusskritieren gelten:

    1. Der Patient hat eine Überlebenswahrscheinlichkeit < 48 Stunden bei Randomisierung;
    2. Teilnahme an einer anderen klinischen Interventionsstudie;
    3. Spezifische immunmodulatorische Behandlung von COVID-19 gemäß der S3 Living-Leitlinie für seit mehr als 72 Stunden bei Randomisierung;
    4. Vorbestehende dauerhafte systemische oder inhalative Glukokortikoid Behandlung;
    5. Der Patient wurde in den letzten 30 Tagen vor Randomisierung mit einem immunsuppressiven/ zytostatischen Medikament behandelt;
    6. Der Patient leidet an einer immunsuppressiven Erkrankung;
    7. Der Patient leidet an einer schweren chronisch entzündlichen Erkrankung der Atemwege, bspw. COPD Stadium 3;
    8. Dialysepflichtiges Nierenversagen
    9. Akutes Leberversagen
    10. Chronisches Herzversagen (NYHA III/IV)
    11. Akutes Rechtsherzversagen
    12. Eindeutige Evidenz für eine bakterielle, virale (ausgenommen SARS-CoV-2) oder Pilzinfektion, inklusive aktiver Tuberkulose
    13. Der Patient wird mit Chloramphenocol behandelt;
    14. Der Patient wird mit Nefazodone behandelt;
    15. Der Patient wird mit Cimetidin behandelt;
    16. Der Patient wird mit einem Makrolidantibiotikum behandelt;
    17. Der Patient wird mit einem Azol-Antimykoticum behandelt;
    18. Behandlung mit Phenytoin;
    19. Person, die aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt untergebracht ist
    20. Person, die vom Sponsor, den Prüfärzten oder dem Prüfzentrum abhängig ist

    Siehe Prüfplan, CATCOVID_v1.2, 27.09.2021: Kapitel 7 (Study Population); Unterkapitel 7.1, Seite 37f.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number of ventilator-free days during the study period of 28 days.

    Ventilator-free days are defined as the number of days after the last extubation:
    • Each day after the discharge of a Subject will be counted as ventilator-free day.
    • In case of a tracheal cannula, the equivalent to extubation is 48 hours without respirator.
    • Death will be counted as “zero ventilator-free days”, regardless of whether the patient was
    intubated at any point or not

    For further definitions, see Protocol_CATCOVID_v1.2 (27.09.2021), Chapter 5.1 and Figure 1 (page 30).
    Anzahl der beatmungsfreien Tage während der 28-tägigen klinischen Prüfung.
    Die maschinelle Beatmung ist eines der klinischen Schlüsselmerkmale eines schweren bzw. kritischen COVID-19 Verlaufs sowie ein Surrogatparameter für die Utilisation von intensivmedizinischen Ressourcen. Somit liefert die Anzahl der beatmungsfreien Tage bei den COVID-19 Patienten dieser klinischen Phase II Studie ein gutes Maß für die Beurteilung des Krankheitsverlaufs, beispielsweise eine verbesserte Prognose, falls die Patientenkohorte, die BAY 86-5277 erhält, mehr beatmungsfreie Tage aufweist als die Placebogruppe.

    Mortalität geht als “Null beatmungsfreie Tage” in die Bewertung ein. Weitere Definitionen sind dem Kapitel 5.1 und Abbildung 1 des Prüfplans CATCOVID_v1.2 (27.09.2021) zu entnehmen (Seite 30).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ventilator-free days at day 28
    Beatmungsfreie Tage nach 28 Tagen
    E.5.2Secondary end point(s)
    Secondary Endpoints

    1. WHO clinical progression scale*;
    2. Severity of gas exchange impairment (paO2/FiO2)*;
    3. Duration in days of supplemental oxygen*;
    4. Duration in days of MV*;
    5. ICU-free days*;
    6. Duration in days of hospitalization*;
    7. SOFA at Day 1, 10, 28;
    8. Mortality; date & cause of death (if applicable);
    9. Documentation of AEs and SAEs (if applicable);
    10. Determination of total and unbound drug concentration in a sub-cohort during the 10
    days study medication treatment period

    *at Day 28

    See Protocol, CATCOVID_ v1.2, 27.09.2021: Chapter 5 (Objectives and Endpoints); Subchapter 5.2, page 31.
    Neben dem primären Ziel und Endpunkt werden weitere klinische Parameter zur detaillierteren Beurteilung des klinischen Verlaufs unter BAY 86-5277- bzw. Placebo-Behandlung erhoben und dokumentiert.

    Weitere klinische Endpunkte (secondary endpoints):
    1. WHO clinical progression scale*;
    2. Schweregrad der Gasaustauschstörung (Verhältnis paO2/FiO2)*;
    3. Dauer des Sauerstoffbedarfs in Tagen*;
    4. Dauer der maschinellen Beatmung in Tagen* (falls zutreffend);
    5. ITS-freie Tage*;
    6. Hospitalisierungsdauer in Tagen*;
    7. SOFA an Tag 1, 10, 28;
    8. Mortalität (Datum und Ursache)
    9. Dokumentation (schwerer) unerwünschter Ereignisse über die Studiendauer von 28 Tagen
    10. Bestimmung der gebundenen sowie ungebundenen Wirkstoff-konzentration in einer Subkohorte während des 10-tägigen Behandlungszeitraums

    *nach 28 Tagen

    Siehe Prüfplan, CATCOVID_ v1.2, 27.09.2021: Kapitel 5 (Objectives and Endpoints); Unterkapitel 5.2, Seite 31
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. WHO clinical progression scale*;
    2. Severity of gas exchange impairment (paO2/FiO2)*;
    3. Duration in days of supplemental oxygen*;
    4. Duration in days of MV*;
    5. ICU-free days*;
    6. Duration in days of hospitalization*;
    7. SOFA at Day 1, 10, 28;
    8. Mortality; date & cause of death (if applicable);
    9. Documentation of AEs and SAEs (if applicable);
    10. Determination of total and unbound drug concentration in a sub-cohort during the 10
    days study medication treatment period

    *at Day 28
    1. WHO clinical progression scale*;
    2. Schweregrad der Gasaustauschstörung (Verhältnis paO2/FiO2)*;
    3. Dauer des Sauerstoffbedarfs in Tagen*;
    4. Dauer der maschinellen Beatmung in Tagen* (falls zutreffend);
    5. ITS-freie Tage*;
    6. Hospitalisierungsdauer in Tagen*;
    7. SOFA an Tag 1, 10, 28;
    8. Mortalität (Datum und Ursache)
    9. Dokumentation (schwerer) unerwünschter Ereignisse über die Studiendauer von 28 Tagen
    10. Bestimmung der gebundenen sowie ungebundenen Wirkstoff-konzentration in einer Subkohorte während des 10-tägigen Behandlungszeitraums

    *nach 28 Tagen
    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 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 concerned4
    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 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
    End of the practical part of the clinical study = last patient out after 13 months. The subjects participate in the clinical study for 28 days. the duration of the clinical study per patient is 28 days.
    Ende des praktischen Teils der klinischen Studie = last patient out nach 13 Monaten. Die Probanden nehmen für 28 Tage an der klinischen Studie teil. die Dauer der klinischen Studie je Patient beträgt 28 Tage.
    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 months1
    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: 208
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 208
    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 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 state208
    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)
    To gain knowledge about long-term efficacy of BAY 86-5277 regarding the COVID-19 progression, individual Subjects will be monitored over a period of 12 months:
    • Primary and secondary endpoints that will be documented on Day 28, will be documented on Day 60 (suggested by FDA)
    • Subjects will be asked to answer two questionnaires (SF-36, Long-COVID) after Month 3, 6, 12 post randomization. No site visits required; Questionnaires will be provided via mail and, if necessary, discussed via phone
    Um Erkenntnisse über die langfristige Wirksamkeit von BAY 86-5277 zu gewinnen, werden einzelne Probanden über Zeitraum von 12 Monaten beobachtet:
    - Primäre und sekundäre Endpunkte, die an Tag 28 dokumentiert werden, werden an Tag 60 dokumentiert
    - Probanden werden gebeten, zwei Fragebögen (SF-36, Long-COVID) nach Monat 3, 6 und 12 nach der Randomisierung zu beantworten. Keine Besuche vor Ort erforderlich; Fragebögen werden per Post zugestellt und, falls erforderlich, telefonisch besprochen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Charité - Universitätsmedizin Berlin
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Universitätsklinikum Leipzig
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation BG Klinikum Unfallkrankenhaus Berlin gGmbH
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Universitätsklinikum Würzburg
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Bayer AG
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Berlin Institute of Health at Charité
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-20
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