Clinical Trials Register

Summary
EudraCT Number:	2020-004743-83
Sponsor's Protocol Code Number:	SG018
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-03-30
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-004743-83

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19

Sperimentazione di fase III, randomizzata, in doppio cieco, controllata con placebo per determinare l’efficacia e la sicurezza di SNG001 per via inalatoria per il trattamento di pazienti ospedalizzati per COVID-19 di grado moderato

A.3.1

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

A trial of an inhaled antiviral drug to treat or prevent severe respiratory difficulties in patients hospitalised with moderate COVID-19

Sperimentazione su un farmaco antivirale per inalazione per il trattamento o la prevenzione di difficoltà respiratorie gravi nei pazienti ospedalizzati per COVID-19 moderato

A.3.2

Name or abbreviated title of the trial where available

SPRINTER

A.4.1

Sponsor's protocol code number

SG018

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	Synairgen Research Limited
B.1.3.4	Country	United Kingdom
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	Synairgen Research Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Synairgen Research Ltd
B.5.2	Functional name of contact point	Sophie Hemmings
B.5.3	Address:
B.5.3.1	Street Address	Mail Point 810, Level F, Southampton General Hospital
B.5.3.2	Town/ city	Tremona Road, Southampton
B.5.3.3	Post code	SO16 6YD
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	02380512800
B.5.5	Fax number	02380512800
B.5.6	E-mail	Sophie.Hemmings@synairgen.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	Interferon beta-1a (IFN-ß1a)
D.3.2	Product code	[SNG001]
D.3.4	Pharmaceutical form	Inhalation 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.3.8	INN - Proposed INN	Interferon beta-1a
D.3.9.2	Current sponsor code	SNG001
D.3.9.4	EV Substance Code	AS1
D.3.10	Strength
D.3.10.1	Concentration unit	million IU million international units
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Yes
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	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

COVID-19

E.1.1.1

Medical condition in easily understood language

Lung disease caused by the new coronavirus

Malattia polmonare causata dal nuovo coronavirus

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10021881
E.1.2	Term	Infections and infestations
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo.

Valutare il recupero nei pazienti affetti da COVID-19 moderata in seguito alla somministrazione di SNG001 rispetto al placebo.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19, using a range of endpoints.

To assess the general safety and tolerability of SNG001 compared to placebo when administered to patients with moderate COVID-19.

Valutare l’efficacia di SNG001 rispetto al placebo in pazienti affetti da COVID-19 moderata, utilizzando una serie di endpoint.

Valutare la sicurezza e la tollerabilità generale di SNG001 rispetto al placebo, quando somministrato a pazienti affetti da COVID-19 moderata.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, =18 years of age at the time of consent.
2. Admitted to hospital due to the severity of their COVID-19.
3. Positive virus test for SARS-CoV-2 using a validated molecular assay
or antigen assay. Patients who had positive virus test for SARS-CoV-2
prior to hospitalisation will be randomised no later than 48 hours after
hospital admission. If the virus test was performed more than 96 hours
prior to hospitalisation, the test will have to be repeated in the hospital
prior to randomisation. Only patients whose repeated virus test is
positive will be randomised, no later than 48 hours after confirmation of
SARS-CoV-2 infection.
Patients who had positive virus test for SARS-CoV-2 after hospitalisation
will be randomised no later than 48 hours after confirmation of SARSCoV-
2 infection.
4. Require oxygen therapy via nasal prongs or mask (OSCI score of 4).
5. Provided informed consent.
6. Female patients must be =1 year post-menopausal, surgically sterile,
or using a highly effective method of contraception. Acceptable highly
effective methods of contraception include;
• bilateral tubal occlusion
• intrauterine device (provided coils are copper-banded)
• levonorgestrel intrauterine system (e.g., Mirena™)
• medroxyprogesterone injections (e.g., Depo-Provera™)
• etonogestrel implants (e.g., Implanon™, Norplan™)
• normal and low dose combined oral pills
• norelgestromin/ ethinylestradiol transdermal system
• intravaginal device (e.g., ethinylestradiol and etonogestrel),
desogestrel (e.g., Cerazette™)
• total sexual abstinence (defined as refraining from heterosexual
intercourse)
• vasectomised sexual partner.
Women should have been stable on their chosen method of birth control
for a minimum of 3 months before entering the trial and should continue
with birth control for 1 month after the last dose of inhaled IFNß1a/
matching placebo. In addition to the highly effective method of
contraception (except for the practice of total sexual abstinence), a
condom (in UK with spermicides) should be used by the male partner for
sexual intercourse from randomisation (Visit 2) and for 1 month after
the last dose of inhaled IFN-ß1a/matching placebo to prevent
pregnancy.
7. Women not of childbearing potential are defined as women who are
either permanently sterilized (hysterectomy, bilateral oophorectomy, or
bilateral salpingectomy), or who are postmenopausal. Women will be
considered post-menopausal if they have been amenorrhoeic for 12
months prior to the planned date of randomisation without an
alternative medical cause. The following age specific requirements
apply:
• Women <50 years old would be considered post-menopausal if they
have been amenorrhoeic for 12 months or more following cessation of
exogenous
hormonal treatment and if follicle stimulating hormone (FSH) levels are
in the postmenopausal range.
• Women =50 years old would be considered post-menopausal if they
have been amenorrhoeic for 12 months or more following cessation of all
exogenous hormonal treatment.
If, in the setting of the pandemic, the use of an acceptable birth control
method is not possible, the decision to enrol a woman of childbearing
potential should be based on the benefit-risk for the patient, which
should be discussed with the patient at the time of the informed consent.

1. Sesso maschile o femminile, età =18 anni al momento del consenso.
2. Ricoverato in ospedale a causa della gravità della COVID-19.
3. Test virale positivo per SARS-CoV-2 mediante un test molecolare o un test per il rilevamento dell’antigene convalidato. I pazienti che presentavano positività al test virale per SARS-CoV-2 prima dell’ospedalizzazione saranno randomizzati non più tardi di 48 ore dopo il ricovero in ospedale. Se il test virale è stato effettuato più di 96 ore prima dell’ospedalizzazione, il test dovrà essere ripetuto in ospedale prima della randomizzazione. Solo i pazienti il cui test virale ripetuto risulta positivo saranno randomizzati, non più tardi di 48 ore dopo la conferma dell’infezione da SARS-CoV-2.
I pazienti che presentavano positività al test virale per SARS-CoV-2 dopo l’ospedalizzazione saranno randomizzati non più tardi di 48 ore dopo la conferma dell’infezione da SARS-CoV-2.
4. Necessita' di ossigenoterapia mediante forcelle nasali o maschera facciale (punteggio OSCI pari a 4).
5. Ha ricevuto il consenso informato.
6. Le pazienti di sesso femminile devono essere in post-menopausa da =1 anno, chirurgicamente sterili o utilizzare un metodo contraccettivo altamente efficace. I metodi contraccettivi altamente efficaci accettabili includono:
• occlusione tubarica bilaterale
• dispositivo intrauterino (a condizione che le spirali siano avvolte con rame)
• sistema intrauterino a base di levonorgestrel (ad es., Mirena™)
• iniezioni di medrossiprogesterone (ad es., Depo-Provera™)
• impianti di etonogestrel (ad es., Implanon™, Norplan™)
• pillole orali combinate a dose normale e bassa
• sistema transdermico a base di norelgestromina/etinilestradiolo
• dispositivo intravaginale (ad es., etinilestradiolo ed etonogestrel), desogestrel (ad es., Cerazette™)
• astinenza sessuale totale (definita come l’astensione da rapporti eterosessuali)
• partner vasectomizzato.
Le donne devono seguire in modo stabile il metodo di contraccezione scelto da un minimo di 3 mesi prima di entrare nella sperimentazione e devono continuare con il metodo di contraccezione per 1 mese dopo l’ultima dose di IFN-ß1a/placebo corrispondente per via inalatoria. In aggiunta al metodo contraccettivo altamente efficace (fatta eccezione per la pratica di astinenza sessuale totale), un preservativo (nel Regno Unito con aggiunta di spermicidi) deve essere utilizzato dal partner di sesso maschile per i rapporti sessuali a partire dalla randomizzazione (Visita 2) e per 1 mese dopo l’ultima dose di IFN-ß1a/placebo corrispondente per via inalatoria al fine di prevenire la gravidanza.
7. Le donne non potenzialmente fertili sono definite come donne che sono permanentemente sterilizzate (isterectomia, ovariectomia bilaterale o salpingectomia bilaterale) o che sono in postmenopausa. Le donne saranno considerate in postmenopausa se amenorroiche da 12 mesi prima della data prevista della randomizzazione senza una causa medica alternativa. Si applicano i seguenti requisiti specifici per l’età:
• Le donne di età <50 anni saranno considerate essere in post-menopausa se amenorroiche da almeno 12 mesi dopo la cessazione del trattamento ormonale esogeno e se i livelli di ormone follicolo-stimolante (Follicle Stimulating Hormone, FSH) rientrano nell’intervallo post-menopausale.
• Le donne di età =50 anni saranno considerate essere in post-menopausa se amenorroiche da almeno 12 mesi dopo la cessazione dell’intero trattamento ormonale esogeno.
Se, nel contesto della pandemia, l’uso di un metodo contraccettivo accettabile non è possibile, la decisione di arruolare una donna in età fertile deve essere basato sul rapporto rischio-beneficio per la paziente, che dovrebbe essere discusso con la paziente al momento del consenso informato.

E.4

Principal exclusion criteria

1. Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks,
confirmed by a validated molecular assay or validated antigen assay.
2. Non-invasive ventilation or high-flow oxygen (OSCI score of 5).
3. Mechanical ventilation (continuous or intermittent CPAP or intubation)
or admission to intensive care (OSCI score of = 6).
4. Previous SARS-CoV-2 infection confirmed by a validated molecular
assay or validated antigen assay.
5. Any condition, including findings in the patients' medical history or in
the pre-randomisation study assessments that in the opinion of the
Investigator, constitute a risk or a contraindication for the participation
of the patient into the study or that could interfere with the study
objectives, conduct or evaluation.
6. Participation in previous clinical trials of SNG001.
7. Current or previous participation in another clinical trial where the
patient has received a dose of an Investigational Medicinal Product
(IMP) containing small molecules within 30 days or 5 half-lives
(whichever is longer) prior to entry into this study or containing
biologicals within 3 months prior to entry into this study.
8. Inability to use a nebuliser with a mouthpiece.
9. Inability to comply with the requirements for storage conditions of
study medication in the home setting.
10. History of hypersensitivity to natural or recombinant IFN-ß or to any
of the excipients in the drug preparation.
11. Females who are breast-feeding, lactating, pregnant or intending to
become pregnant.
12. Previous SARS-CoV-2 vaccination.

1. Evidenza di infezione da SARS-CoV-2 in corso da più di 3 settimane, confermata da un test molecolare o un test per il rilevamento dell’antigene convalidato.
2. Ventilazione non invasiva od ossigeno ad alto flusso (punteggio OSCI pari a 5).
3. Ventilazione meccanica (CPAP continua o intermittente o intubazione) o ricovero in terapia intensiva (punteggio OSCI =6).
4. Precedente infezione da SARS-CoV-2 confermata da un test molecolare o un test per il rilevamento dell’antigene convalidato.
5. Qualsiasi condizione, compresi i risultati nell’anamnesi medica dei pazienti o nelle valutazioni pre-randomizzazione dello studio che, a giudizio dello sperimentatore, rappresenti un rischio o una controindicazione per la partecipazione del paziente allo studio o che potrebbe interferire con gli obiettivi, la conduzione o la valutazione dello studio.
6. Partecipazione a sperimentazioni cliniche precedenti di SNG001.
7. Attuale o precedente partecipazione a un’altra sperimentazione clinica in cui il paziente ha ricevuto una dose di un prodotto medicinale sperimentale (Investigational Medicinal Product, IMP) contenente molecole di piccole dimensioni nei 30 giorni o 5 emivite (a seconda di quale periodo sia più lungo) precedenti l’ingresso in questo studio o contenente elementi biologici nei 3 mesi precedenti l’ingresso in questo studio.
8. Incapacità di utilizzare un nebulizzatore con un boccaglio.
9. Incapacità di conformarsi con i requisiti per le condizioni di conservazione del farmaco dello studio a domicilio.
10. Anamnesi di ipersensibilità a IFN-ß naturale o ricombinante, o ad uno qualsiasi degli eccipienti presenti nella preparazione del farmaco.
11. Soggetti di sesso femminile che stiano allattando al seno, in gravidanza o che intendono iniziare una gravidanza.
12. Precedente vaccinazione contro SARS-CoV-2.

E.5 End points

E.5.1

Primary end point(s)

Time to hospital discharge, defined by the OSCI score of 2 or below, with no rebound at subsequent assessments.
Time to recovery, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments.

Tempo alla dimissione dall’ospedale, definito come punteggio OSCI pari o inferiore a 2, senza recidiva alle valutazioni successive.
Tempo al recupero, laddove il recupero è definito come punteggio OSCI pari o inferiore a 1, senza recidiva alle valutazioni successive.

E.5.1.1

Timepoint(s) of evaluation of this end point

OSCI assessments will be conducted daily between day 1 and day 35.
Time to recovery will be assessed over the first 28 days of the study period. The OSCI assessments after day 28 will be used to assess relapse only.

Le valutazioni OSCI saranno condotte quotidianamente tra il giorno 1 e il giorno 35.
Il tempo per il recupero sarà valutato nei primi 28 giorni del periodo di studio. Le valutazioni OSCI dopo il giorno 28 verranno utilizzate solo per valutare la ricaduta.

E.5.2

Secondary end point(s)

Key Secondary Endpoints:
a. Progression to severe disease or death, defined by the OSCI score of 5 or above within 35 days of first dose.
b. Progression to intubation or death, defined by the OSCI score of 6 or
above within 35 days of first dose.
c. Death within 35 days of first dose.
Secondary Endpoints:
a. Recovery, where recovery is defined as the OSCI score of 1 or below,
with no rebound at subsequent assessments, at Days 7, 14, 21 and 28.
b. Hospital discharge at Days 7, 14, 21 and 28.
c. Improvement across the entire OSCI at Days 7, 14, 21 and 28.
d. Changes in breathlessness, cough and sputum scale (BCSS) score
during the study period, including disaggregated breathlessness and
cough scores.
e. Changes in National Early Warning Score 2 (NEWS2) during the
hospitalisation period.
f. Daily assessment of COVID-19 symptoms and limitation of usual
activities.
g. Quality of life measured using EQ-5D-5L.
h. Long-COVID-19 symptoms.
i. Safety and tolerability – vital signs, AEs and concomitant medications.

Endpoint secondari chiave:
a. Progressione a malattia grave o decesso, definito come punteggio OSCI pari o superiore a 5 entro 35 giorni dalla prima dose.
b. Progressione a intubazione o decesso, definito come punteggio OSCI pari o superiore a 6 entro 35 giorni dalla prima dose.
c. Decesso entro 35 giorni dalla prima dose.
End point secondari:
a. Recupero, laddove il recupero è definito come punteggio OSCI pari o inferiore a 1, senza recidiva alle valutazioni successive, nei Giorni 7, 14, 21 e 28.
b. Tempo alla dimissione dall’ospedale ai Giorni 7, 14, 21 e 28.
c. Miglioramento in tutto l’OSCI ai Giorni 7, 14, 21 e 28.
d. Variazioni dei punteggi della Scala della dispnea, tosse ed espettorato (Breathlessness, Cough and Sputum Scale, BCSS) durante il periodo dello studio, inclusi i punteggi disaggregati di dispnea e tosse.
e. Variazioni nel Punteggio nazionale dei livelli di allerta precoce 2 (National Early Warning Score 2, NEWS2) durante il periodo di ricovero ospedaliero.
f. Valutazione giornaliera dei sintomi di COVID-19 e limitazione delle attività abituali.
g. Qualità della vita misurata utilizzando il questionario EQ-5D-5L [European Questionnaire-5 Levels-5 Dimensions (Questionario europeo a 5 livelli e 5 dimensioni)].
h. Sintomi a lungo termine di COVID-19.
i. Sicurezza e tollerabilità: segni vitali, EA e farmaci concomitanti.

E.5.2.1

Timepoint(s) of evaluation of this end point

Key secondary endpoints
Progression to severe disease or death will be assessed using all postbaseline
OSCI assessments up to day 28.
Time to hospital discharge will be assessed over the first 28 days of the
study period. The OSCI assessments after day 28 will be used to assess
relapse only.
For Secondary endpoints the timepoints for evaluation are stated in the
endpoint wording as per questions E5-2.

Endpoint secondari chiave
La progressione alla malattia grave o alla morte sarà valutata utilizzando tutto il periodo successivo al basale con valutazioni OSCI fino al giorno 28.
Il tempo necessario alla dimissione dall'ospedale sarà valutato nei primi 28 giorni del periodo di studio. Per la valutazione verranno utilizzate le valutazioni OSCI dopo il giorno 28 solo ricaduta.
Per gli endpoint secondari i tempi per la valutazione sono indicati nel file
formulazione dell'endpoint come da domande E5-2.

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Brazil

Colombia

India

Israel

Mexico

Serbia

United States

Belgium

France

Italy

Portugal

Romania

Spain

United Kingdom

Argentina

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

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

305

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

305

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.4.2

For a multinational trial

F.4.2.1

In the EEA

234

F.4.2.2

In the whole clinical trial

610

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)

As this study drug is only given once a day for 14 days while participants are enrolled onto the study and infected with SARS-CoV-2 infection, the study drug will not be available after the research has finished.

Poiché questo farmaco in studio viene somministrato solo una volta al giorno per 14 giorni mentre i partecipanti sono arruolati nello studio e infettati con infezione da SARS-CoV-2, il farmaco in studio non sarà disponibile al termine della ricerca.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Transcrip
G.4.3.4	Network Country	United States

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-04-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-03

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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