Clinical Trials Register

Summary
EudraCT Number:	2017-003855-47
Sponsor's Protocol Code Number:	AP301-II-002
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-02-02
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

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2017-003855-47

A.3

Full title of the trial

Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability oedema in patients with moderate-to-severe ARDS - a randomised, placebo-controlled, double-blind trial

Bewertung der Sicherheit und vorläufgien Wirksamkeit sequenziell ansteigender Dosierungen von Solnatide zur Behandlung des pulmonalen Permeabilitätsödems bei Patienten mit mäßigem bis schwerem akutem Atemnotsyndrom (ARDS) – eine randomisierte, Placebo kontrollierte Doppelblindstudie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.4.1

Sponsor's protocol code number

AP301-II-002

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Apeptico Forschung und Entwicklung GmbH
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Apeptico Forschung und Entwicklung GmbH
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Apeptico Forschung und Entwickling
B.5.2	Functional name of contact point	Prof. Dr. Bernhard Fischer
B.5.3	Address:
B.5.3.1	Street Address	Mariahilfer Straße 136, Top 1.15
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1150
B.5.3.4	Country	Austria
B.5.4	Telephone number	00436641432919
B.5.5	Fax number	0043664330337795
B.5.6	E-mail	b.fischer@apeptico.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/09/677
D.3 Description of the IMP
D.3.1	Product name	Solnatide
D.3.4	Pharmaceutical form	Powder for nebuliser solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	259206-53-06
D.3.9.2	Current sponsor code	AP301
D.3.9.3	Other descriptive name	human tumour necrosis factor alpha-derived peptide Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-Ala-Lys-Pro-Trp-Tyr-Cys
D.3.9.4	EV Substance Code	SUB120783
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/09/677
D.3 Description of the IMP
D.3.1	Product name	Solnatide
D.3.4	Pharmaceutical form	Nebuliser solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	259206-53-06
D.3.9.2	Current sponsor code	AP301
D.3.9.3	Other descriptive name	human tumour necrosis factor alpha-derived peptide Cys-Gly-Gln-Arg-Glu-Thr-Pro-
D.3.9.4	EV Substance Code	SUB120783
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solvent for...
D.8.4	Route of administration of the placebo	Inhalation use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Inhalation solution
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

pulmonary permeability oedema in patients with moderate-to-severe ARDS

E.1.1.1

Medical condition in easily understood language

Acute Lung Injury

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10003083
E.1.2	Term	ARDS
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10037423
E.1.2	Term	Pulmonary oedema
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the local and systemic safety of 7 days orally inhaled sequential multiple ascending doses of solnatide in patients with pulmonary permeability oedema and moderate-to-severe ARDS.

Bewertung der lokalen und systemischen Sicherheit einer siebentägigen, oralen Inhalation sequenziell ansteigender Dosierungen von Solnatide zur Behandlung des pulmonalen Permeabilitätsödems bei Patienten mit mäßigem bis schwerem ARDS.

E.2.2

Secondary objectives of the trial

To review potential efficacy endpoints for a future phase III pivotal trial.

Identifizierung möglicher Parameter zur Wirksamkeitsbewertung im Rahmen einer zukünftigen Phase III Zulassungsstudie.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The study will enrol patients with pulmonary permeability oedema (EVLWI ≥ 10) and 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 (for details see Section 10.1.1)
2. Male or female ≥18 years of age
3. Patient has been admitted to an ICU, is mechanically ventilated (according to the ventilation and weaning protocol as outlined in the study protocol) and stable in this condition for at least 8 hours
4. 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 with Positive End-Expiratory Pressure (PEEP) ≥5 cm H2O
5. Verified ARDS diagnosis (moderate or severe according to BERLIN Definition) not older than 48 hours
6. Extravascular lung water index (EVLWI) ≥ 10 mL/PBW, as assessed with a validated bedside measurement (single indicator transpulmonary thermodilution measurement with the PiCCO system)
7. Patient who meets criteria for extensive hemodynamic monitoring as per international intensive-care medicine standards

Es werden mechanisch beatmete Intensivpatienten mit einem pulmonalen Permeabilitätsödem (EVLWI ≥ 10) und mäßigem bis schwerem ARDS in die Studie aufgenommen. Um in die Studie aufgenommen zu werden, muss ein Patient sämtliche nachfolgend genannten Kriterien erfüllen:
1. Einverständniserklärung (Einzelheiten s. Abschnitt 10.1.1)
2. Männlich oder weiblich ≥ 18 Jahre
3. Mechanisch beatmeter Intensivpatient (s. Beatmungsproto-koll im Prüfplan) mindestens acht Stunden in stabilem Zu-stand
4. Diagnose eines mäßigen bis schweren ARDS gemäß der Berlin Definition:
• Beginn des ARDS innerhalb von 1 Woche nach einem bekannten klinischen Insult oder neu aufgetretene bzw. Verschlechterung vorhandener respiratorischer Symptome
• Bilaterale Verdichtungen in der Röntgen-Thorax-Aufnahme oder Computertomographie, die nicht auf Effusionen, Lungenversagen oder Knoten zurückgeführt werden können
• Atemnot kann nicht auf das Vorhandensein eines kardialen Lungenödems oder einer Überwässerung zurückgeführt werden
• Quotient des arteriellen Sauerstoffpartialdrucks (PaO2)/inspiratorischer Sauerstoffkonzentration (FiO2) ≤ 200 mmHg, bei einem positiven endexpiratorischen Druck (PEEP) ≥ 5 cm H2O
5. Bestätigte Diagnose des ARDS (mittel oder schwer gemäß BERLIN Definition) nicht älter als 48 Stunden
6. Extravaskulärer-Lungenwasserindex (EVLWI) ≥ 10 mL/ PBW, gemessen anhand der alleinigen transpulmonalen Thermodilution mit Hilfe des PiCCO Systems
7. Patient erfüllt die Kriterien für ein extensives hämo-dynamisches Monitoring gemäß internationalen, intensiv-medizinischen Standards

E.4

Principal exclusion criteria

1. History of clinically relevant allergies or idiosyncrasies to solnatide
2. Known use of any other investigational or non-registered drug within 30 days prior to study enrollment
3. 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
4. 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)
5. Extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support. Patients should not be denied this procedure or the procedure should not be delayed to avoid exclusion from the study.
6. Neutrophil count < 0.3 x 10^9/L
7. Cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks
8. Cachexia (BMI < 18.5 kg/m2)
9. Cardiogenic pulmonary edema diagnosed by echocardiography or pulmonary artery catheter
10. Skin burns involving more than 15% of body surface
11. 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
12. Subjects transferred from a hospital not participating in this study who are already planned to be re-transferred during the observation period
13. Subjects who are not expected to survive the next month because of an underlying uncorrectable medical condition or a do not resuscitate order
14. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test

1. Anamnese klinisch relevanter Allergien oder Unverträglich-
keiten gegenüber Solnatide
2. Anwendung sonstiger Prüfmedikation oder nicht zugelassener
Medikamente innerhalb von 30 Tagen vor Aufnahme in die
Studie
3. Zustand eines schweren septischen Schocks mit einem
Mittleren arteriellen Druck ≤ 65 mm Hg und einer Laktat-
konzentration im Serum ˃ 4 mmol/L (36 mg/dL) trotz ausreich-
endner Volumensubstitution
4. Klinische Anzeichen für das Vorhandensein einer schwer-
wiegenden Grunderkrankung, z.B. erhebliche Mangeler-
nährung, schwere neurologische Erkrankungen, pulmonale
Fibrose oder COPD, wodurch nach Ansicht des Prüfarztes eine
Erfolgreiche Entwöhnung von der mechanischen Beatmung un-
wahrscheinlich ist
5. Extrakorporale Membranoxygenierung, Hochfrequenzbe-
atmung oder andere Form einer extrakorporalen Lungen-
unterstützung. Patienten darf dieses Verfahren auf keinen Fall
verweigert oder das Verfahren verzögert werden, um einen Ausschluss aus der Studie zu vermeiden.
6. Neutrophilenzahl: < 0.3 x 10^9/L
7. Onkotherapie (chemisch oder biologisch) oder eine Behandlung
mit Immunsupressiva zur Organtransplantation innerhalb von 2
Wochen
8. Kachexie (BMI < 18.5 kg/m2)
9. Vorhandensein eines kardialen Lungenödems, diagnostiziert
mittels Echokardiographie oder Pulmonalarterienkatheter
10. Hautverbrennungen von mehr als 15% der Körperoberfläche
11. Patienten, die aufgrund akuter Probleme nach Ansicht des
Prüfarztes mit großer Wahrscheinlichkeit nicht länger als 48
Stunden überleben werden
12. Patienten, die von einem nicht an der Studie teilnehmenden
Krankenhaus überwiesen wurden und bereits während der
Beobachtungsphase zurückverlegt werden sollen
13. Patienten, die aufgrund einer unheilbaren Erkrankung oder
einer Patientenverfügung die kommenden Monate voraus-
sichtlich nicht überleben werden
14. Schwangere oder stillende Frauen oder solche, bei denen ein
positives bzw. nicht eindeutiges Resultat eines Schwanger-
schaftstests vorliegt

E.5 End points

E.5.1

Primary end point(s)

Safety
Safety will be assessed by a review of mortality, the incidence of adverse events and serious adverse events, as well as by analysis of relevant laboratory data and ECG.
Safety parameters
• 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 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
Preliminary efficacy parameters
• Change from baseline to day 7 in 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 (Ppeak), 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
• Ventilator-free days (VFD) (corresponding with the standardized ventilation and weaning protocol) 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.

Sicherheit
Die Bewertung der Sicherheit erfolgt anhand der Sterblichkeitsrate, der Inzidenz von unerwünschten und schwerwiegenden uner-wünschten Ereignissen sowie der Analyse relevanter Laborwerte und des EKG.
Sicherheitsparameter
• Nebenwirkungen (bis einschließlich Tag 14)
• Sämtliche unerwünschten Ereignisse (bis einschließlich Tag 28)
• Sämtliche Todesfälle bis einschließlich Tag 28
• Vitalzeichen bis einschließlich Tag 14 (Puls, systolischer und diastolischer Blutdruck sowie Körpertemperatur)
• EKG Parameter einschl. Puls, PQ, QRS, QT und QTc Intervall bis einschließlich Tag 7
• Klinische Laborwerte (Hämatologie, klinische Chemie, Blutgase und Urinanalyse) bis einschließlich Tag 14
• 24 Stunden Flüssigkeitshaushalt bis einschließlich Tag 7
• Hämodynamische Parameter (durchschnittlicher arterieller Druck, Lungenblutvolumen, Herzindex und Herzminutenvolumen) werden beim Screening sowie täglich bis zum Ende der Behand-lung bestimmt
• Bedarf an vasoaktiven Medikamenten wird vom Screening bis zum Ende der Behandlung täglich bestimmt

Vorläufige Wirksamkeitsparameter
• Bestimmung der Änderung von EVLWI und des pulmonalvaskulären Permeabilitätsindex (PVPI) von Behand-lungsbeginn bis Tag 7 anhand der alleinigen transpulmonalen Thermodilution mit Hilfe des PiCCO Systems
• Bestimmung der Lungencompliance bis einschließlich Tag 14, falls der Patient mechanisch beatmet wird (kontrollierte mechanische Beatmung, unterstützte Atmung, nicht-invasive Beatmung)
• Bestimmung des Murray Lungenschädigungsindex (LIS) bis einschließlich Tag 7, falls eine Röntgen-Thorax Aufnahme vorliegt
• Bestimmung des Oxygenierungsindex (PaO2/FiO2) bis ein-schließlich Tag 7
• Beatmungsparameter: Beatmungsplateaudruck, Atemzugvolu-men (Vt), positive endexpiratorischer Druck (PEEP), Atemfrequenz, inspiratorische Sauerstoffkonzentration (FiO2), maximaler Inspirationsdruck, mittlerer Atemwegsdruck, maxi-maler Atemwegsdruck (Ppeak), Art der Beatmung bis einschließ-lich Tag 14, falls ein Patient mechanisch beatmet wird (kontrollierte mechanische Beatmung, unterstützte Atmung, nicht-invasive Beatmung)
• Druckamplitude (Pplat -PEEP) bis einschließlich Tag 14
• Spontanatmungsversuch
• Zeitraum bis zur Extubation bis einschließlich Tag 28
• Anzahl der beatmungsfreien Tage (entsprechend dem Standardbeatmungs- und Weaning Protokoll) bis einschließlich Tag 28
• Verweildauer im Krankenhaus (Tage) bis einschließlich Tag 28, definiert als Differenz zwischen Entlassungstag und dem Tag der Randomisierung. Tage eines ambulanten Krankenhausaufent-halts werden nicht berücksichtigt.
• Verweildauer auf der Intensivstation (Kalendertage) bis ein-schließlich Tag 28

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline to day 7 respectivly da 28 (+7)

E.5.2

Secondary end point(s)

not applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

n.a.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial 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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subjects might be incapable of giving consent for reasons linked to their medical condition. They have Acute Lung Ingury and are connected to a ventilator.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-06-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-04-27

P. End of Trial
P.	End of Trial Status	Ongoing

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