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    Summary
    EudraCT Number:2020-001244-26
    Sponsor's Protocol Code Number:COV-2-SOLNATIDE-20
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-03-31
    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 ConcernedAustria - BASG
    A.2EudraCT number2020-001244-26
    A.3Full title of the trial
    COVID-19: Efficacy of solnatide to treat pulmonary permeability oedema in SARS-Cov-2 positive patients with moderate-to-severe ARDS - a pilot-trial.
    COVID-19: Wirksamkeit von Solnatide zur Behandlung des pulmonalen Permeabilitätsödems bei SARS-Cov2 positiven Patienten mit mäßigem bis schwerem akutem Atemnotsyndrom (ARDS) – eine randomisierte, Placebo kontrollierte Doppelblindstudie - Pilotstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COVID-19: Efficacy of solnatide to treat pulmonary permeability oedema in SARS-Cov-2 positive patients with moderate-to-severe ARDS - a pilot-trial.
    COVID-19: Wirksamkeit von Solnatide zur Behandlung des pulmonalen Permeabilitätsödems bei SARS-Cov2 positiven Patienten mit mäßigem bis schwerem akutem Atemnotsyndrom (ARDS) – eine randomisierte, Placebo kontrollierte Doppelblindstudie - Pilotstudie
    A.4.1Sponsor's protocol code numberCOV-2-SOLNATIDE-20
    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 SponsorDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna Austria
    B.1.3.4CountryAustria
    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 supportApeptico Forschung und Entwicklung GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna Austria
    B.5.2Functional name of contact pointMarkus Zeitlinger
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.6E-mailmarkus.zeitlinger@meduniwien.ac.at
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/677
    D.3 Description of the IMP
    D.3.1Product nameSolnatide
    D.3.4Pharmaceutical form Powder for nebuliser suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSolnatide
    D.3.9.1CAS number 259206-53-06
    D.3.9.2Current sponsor codeAP301
    D.3.9.3Other descriptive namehuman tumour necrosis factor alpha-derived peptide Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-Ala-Lys-Pro-Trp-Tyr-Cys
    D.3.9.4EV Substance CodeSUB120783
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboSolvent for...
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary permeability oedema in SARS-Cov-2 positive patients with moderate-to-severe ARDS
    Pulmonales Permeabilitätsödem bei SARS-Cov2 positiven Patienten mit mäßigem bis schwerem akutem Atemnotsyndrom (ARDS)
    E.1.1.1Medical condition in easily understood language
    Pulmonary permeability oedema in SARS-Cov-2 positive patients with moderate-to-severe ARDS
    Pulmonales Permeabilitätsödem bei SARS-Cov2 positiven Patienten mit mäßigem bis schwerem akutem Atemnotsyndrom (ARDS)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003083
    E.1.2Term ARDS
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037423
    E.1.2Term Pulmonary oedema
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the efficacy of 7 days orally inhaled 100 mg solnatide in Covid-19 patients with moderate-to-severe ARDS.
    Primary endpoint:
    • Days free of mechanical ventilation (ventilator free days, VFD) within 28 days.
    E.2.2Secondary objectives of the trial
    • Assessment on the effect of solnatide on the extravascular lung-water-index (EVLWI), if available
    • Hemodynamic parameters
    • Ordinal Scale for Clinical Improvement, as proposed by the WHO
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Full title: Biomarker Sub-Study by Prof. Schaden
    Version: 2.0
    Date: 01.04.2020
    Objective:
    -To assess the role of the coagulation system in the pathogenesis of COVID-19
    -To assess the benefit of coagulation markers for the prognosis and course of disease in seriously ill COVID-19 patients
    -To find possible therapeutic targets
    E.3Principal inclusion criteria
    The study will enrol SARS-Cov-2 positive patients with moderate to severe ARDS admitted to an Intensive Care Unit (ICU) and under mechanical ventilation*. To be eligible to participate in this study, an individual must meet all the following criteria:
    1. Informed consent, if possible.
    2. Male or female ≥18 years of age.
    3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen.
    4. Patient has been admitted to an ICU, is mechanically ventilated (according to the ventilation and weaning protocol as outlined in Appendix I) and stable in this condition for at least 8 hours.
    5. Moderate and severe ARDS diagnosis as defined by the Berlin Definition:
    • Onset of ARDS within 1 week of a known clinical insult or new or worsening respiratory symptoms
    • Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules
    • Respiratory failure not fully explained by cardiac failure or fluid overload (origin of oedema)
    • PaO2/FiO2 < 200 mm Hg continuously observed for a period of ≥4hours (≥2 ABG analyses during that time, with the last value obtained shortly prior to randomization), minimum PEEP ≥8 cm H2O
    6. Time from intubation to randomization ≤ 96h
    E.4Principal exclusion criteria
    1. History of clinically relevant allergies or idiosyncrasies to solnatide.
    2. Severe state of septic shock with a Mean Arterial Pressure (MAP) ≤ 65 mm Hg and serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation.
    3. An underlying clinical condition that, in the opinion of the Investigator, would make it very unlikely for the patient to be successfully weaned from ventilation due to severe underlying diseases (e.g. severe malnutrition, severe neurological diseases, pulmonary fibrosis or COPD).
    4. Extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support. In no way are patients to be denied or delayed these procedures to avoid exclusion from the study.
    5. Neutrophil count < 0.3 x 10^9/L.
    6. Subjects who are extremely unlikely to survive more than 48 hours due to the acute conditions of the patient in the opinion of the Investigator.
    7. Subjects who are not expected to survive the next month because of an underlying uncorrectable medical condition or a do not resuscitate order
    8. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
    E.5 End points
    E.5.1Primary end point(s)
    • Days free of mechanical ventilation (ventilator free days, VFD) within 28 days
    • Drug-related adverse events (through day 14)
    • All adverse events through day 28
    • All-cause deaths through day 28
    • Vital signs daily through day 14 (heart rate, systolic and diastolic blood pressure, and body temperature)
    • ECG parameters (if available) including heart rate PQ, QRS, QT and QTc intervals through day 7
    • Clinical laboratory assessments (haematology, clinical chemistry, blood gases and urine analysis) daily through day 14
    • 24-hour fluid balance through day 7
    • Hemodynamic parameters: mean arterial pressure, pulmonary blood volume (PBV), cardiac index and cardiac output assessed at screening and daily until end of treatment
    • Need for vasoactive drugs assessed at screening and daily until end of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to day 7, respectively to day 14 or day 28.
    E.5.2Secondary end point(s)
    • Change in ordinal Scale for Clinical Improvement, as proposed by the WHO (assessed daily until discharge; if early discharge at day 14 and 28 after randomization)
    • All-cause mortality (day 28 and day 60 after randomization)
    • If available, change from baseline to day 7 in extravascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI) as assessed with a validated bedside measurement (single indicator transpulmonary thermodilution measurement with the PiCCO® system)
    • Lung compliance through day 14, if patient is mechanical ventilated (controlled mechanical ventilation)
    • Murray lung injury score (LIS) through day 7 if chest x-ray is available
    • Oxygenation ratio (PaO2 / FiO2 ratio) assessed through day 7
    • Ventilation parameters: ventilatory plateau pressure, tidal volume (Vt), positive end expiratory pressure (PEEP), respiratory rate, FiO2, peak inspiratory pressure (PIP), mean airway pressure, peak airway pressure, ventilation mode through day 14, if patient is mechanical ventilated (controlled mechanical ventilation, assisted breathing, non-invasive ventilation)
    • Driving pressure (Pplat - PEEP) through Day 14
    • Spontaneous breathing trial
    • Time to extubation through day 28
    • Days of hospitalization through day 28, defined as the difference between the date of discharge and the date of randomization. Days of outpatient hospitalization will not be included.
    • ICU days through day 28. ICU days is defined as the number of calendar days a patient was in the ICU until completion of day 28.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to day 7, respectively to day 14, 28 or 60.
    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) 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 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 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
    The end of the study is defined as completion of the last visit or procedure by all patients in the trial.
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 2020-03-31. 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 Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2020-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-08-23
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