Clinical Trials Register

Summary
EudraCT Number:	2020-002394-94
Sponsor's Protocol Code Number:	PULSE-IIT-FluidDA-001
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-06-04
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2020-002394-94

A.3

Full title of the trial

Pulsed, inhaled nitric oxide (iNO) for the treatment of patients with mild or
moderate corona virus disease (COVID-19)

A.3.1

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

Pulsed, inhaled nitric oxide (iNO) for the treatment of patients with mild or
moderate corona virus disease (COVID-19)

Geïnhaleerde stikstofoxide (iNO) voor de behandeling van patiënten met
milde tot gemiddelde ziekteverschijnselen ten gevolge van het coronavirus

A.4.1

Sponsor's protocol code number

PULSE-IIT-FluidDA-001

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	Dr. De Backer Wilfried BV
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bellerophon Pulse Technologies, LLC
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Dr. De Backer Wilfried BV
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	Lange Lozanastraat 142 (Regus 2nd floor)
B.5.3.2	Town/ city	Antwerpen
B.5.3.3	Post code	2018
B.5.3.4	Country	Belgium
B.5.4	Telephone number	0032476084883
B.5.6	E-mail	wilfried.debacker@outlook.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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	iNO
D.3.4	Pharmaceutical form	Pressurised inhalation
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
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	Yes
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Corona virus disease

E.1.1.1

Medical condition in easily understood language

Corona virus disease

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	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10084355
E.1.2	Term	COVID-19 virus test positive
E.1.2	System Organ Class	100000004848

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10084383
E.1.2	Term	Novel COVID-19-infected pneumonia
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10084401
E.1.2	Term	COVID-19 respiratory infection
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The objective of this study is to examine the utility of high resolution
computed tomography (HRCT) to measure changes in functional
pulmonary imaging parameters as a function of iNO administration using
the device INOpulse in relation to the corona virus disease. Changes
from baseling to at least 5 minutes of iNO and after 5 days using iNO 8 to
24 h/day.
Clinical evaluation of INOpulse for patients with COVID-19 using clinical
and imaging endpoints

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Signed Informed Consent Form (and assent as appropriate) prior to
the initiation of any study mandated procedures or assessments.
2. At least 18 years old
3. Hospitalized patients with proven or high suspicion of SARS-CoV-2
infection and on supplemental oxygen >2 L/minute and ≤ 10 L/minute
4. Suspected or proven pneumonia on chest imaging
5. Female patients of childbearing potential must have a negative pretreatment
pregnancy test (serum or urine). All female patients should
take adequate precaution to avoid pregnancy.
6. Willing and able to comply with treatment schedule and study
procedures.

E.4

Principal exclusion criteria

1. Participating in any other clinical trial of an experimental treatment
for COVID-19
2. Gas exchange and ventilation requiring the use of any continuous
positive airway pressure (CPAP), or any system of Non Invasive
Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10
cmH2O prior to initiation of iNO
3. Pregnancy, or positive pregnancy test in a pre-dose examination
4. Open tracheostomy
5. Clinical contra-indication, as deemed by the attending physician including chronic lung disease
6. Use of a nitric oxide donor agent such as nitroglycerin or drugs
known to increase methemoglobin such as lidocaine, prilocaine,
benzocaine or dapsone at screening
7. Known history or clinical evidence of heart failure, left ventricular
dysfunction (LVEF < 40 %)
8. Patients reporting hemoptysis

E.5 End points

E.5.1

Primary end point(s)

Clinical evaluation of INOpulse for patients with COVID-19 using clinical
1. Death
2. Hospitalized, requiring mechanical ventilation or ECMO
3. Hospitalized, requiring non-invasive ventilation or high flow oxygen
4. Hospitalized, requiring supplemental oxygen
5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
6. Hospitalized, not requiring supplemental oxygen - not requiring ongoing medical care (COVID-19 related or otherwise)
7. Not hospitalized - limitation on activities and/or requiring home oxygen
8. Not hospitalized, no limitations on activities

E.5.1.1

Timepoint(s) of evaluation of this end point

Assessed at the start of iNOpulse treatment,during treatment, upon completion of treatment and at follow up (Day 28).

E.5.2

Secondary end point(s)

The following CT derived anatomical and functional parameters should be reported based on the initial CT’s taken before and during iNO inhalation: imaged airway volume (iVaw), imaged airway resistance (iRaw), blood vessels volumes for different sized vessels (<5 mm2, between 5-10 mm2, larger than 10 mm2)

E.5.2.1

Timepoint(s) of evaluation of this end point

At baseline, after at least 5 minutes and after 5 daysof iNO (using 8 to
24 h/day)

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

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

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

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

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

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.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

Follow up 28 days after start treatment

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

2020-06-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-19

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

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