Clinical Trials Register

Summary
EudraCT Number:	2020-005890-29
Sponsor's Protocol Code Number:	ETCStudy
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-03-22
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-005890-29

A.3

Full title of the trial

Comparative efficacy of therapeutic strategies for at home early treatment of mild or moderate COVID-19 patients on the reduction of the risk of disease worsening:
A multi-stage multi-arm adaptive randomized cluster trial

Efficacia comparativa delle strategie terapeutiche per il trattamento domiciliare precoce di pazienti con COVID-19 lieve o moderata sulla riduzione del rischio di peggioramento della malattia:
Uno studio multistadio multi-braccio adattivo randomizzato a grappolo

A.3.1

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

Multi-arm randomized trial, comparing the efficacy of therapeutic strategies for at home early treatment of mild or moderate COVID-19 (SARS-CoV-2 infection) patients on the reduction of the risk of disease worsening

Studio a più bracci di trattamento, casualmente assegnati, che confronta l'efficacia degli schemi terapeutici per il trattamento domiciliare precoce di pazienti con COVID-19 (infezione da SARS-CoV-2) lieve o moderata nel ridurre il rischio di peggioramento della malattia

A.3.2

Name or abbreviated title of the trial where available

Early Treatment of COVID-19 infection – The ETC study

Trattamento precoce della COVID-19 (infezione da SARS-CoV-2)

A.4.1

Sponsor's protocol code number

ETCStudy

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	FONDAZIONE RICERCA TRASLAZIONALE (FORT)
B.1.3.4	Country	Italy
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clinical Research Technology
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Via San Leonardo trav. Migliaro
B.5.3.2	Town/ city	Salerno
B.5.3.3	Post code	84131
B.5.3.4	Country	Italy
B.5.4	Telephone number	089301545
B.5.5	Fax number	0897724155
B.5.6	E-mail	etcstudy@cr-technology.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
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	Paracetamolo
D.3.2	Product code	[Paracetamolo]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PARACETAMOLO
D.3.9.2	Current sponsor code	Paracetamolo
D.3.9.3	Other descriptive name	Paracetamol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
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	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	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	Yes
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	Celecoxib
D.3.2	Product code	[Celecoxib]
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CELECOXIB
D.3.9.2	Current sponsor code	Celecoxib
D.3.9.3	Other descriptive name	Celecoxib
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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	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	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: 3
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	Yes
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	Paracetamolo
D.3.2	Product code	[Paracetamolo]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PARACETAMOLO
D.3.9.2	Current sponsor code	Paracetamolo
D.3.9.3	Other descriptive name	Paracetamol
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1000
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	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	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: 4
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	Yes
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	Enoxaparina
D.3.2	Product code	[Enoxaparina]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ENOXAPARINA SODICA
D.3.9.2	Current sponsor code	Enoxaparina
D.3.9.3	Other descriptive name	Enoxaparin
D.3.10	Strength
D.3.10.1	Concentration unit	anti-Xa IU anti-Xa activity International Unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4000
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	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: 5
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	Yes
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	Enoxaparina
D.3.2	Product code	[Enoxaparina]
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ENOXAPARINA SODICA
D.3.9.2	Current sponsor code	Enoxaparina
D.3.10	Strength
D.3.10.1	Concentration unit	anti-Xa IU anti-Xa activity International Unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6000
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	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

Mild or moderate COVID-19 (Coronavirus Disease 19), not requiring hospitalization

COVID-19 (Malattia da Coronavirus 19) lieve o moderata, che non richiede ospedalizzazione

E.1.1.1

Medical condition in easily understood language

Mild or moderate COVID-19 (Coronavirus Disease 19), not requiring hospitalization

COVID-19 (Malattia da Coronavirus 19) lieve o moderata, che non richiede ospedalizzazione

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	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10053983
E.1.2	Term	Corona virus infection
E.1.2	System Organ Class	100000004862

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	10070255
E.1.2	Term	Coronavirus test positive
E.1.2	System Organ Class	10022891 - Investigations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Identify the most suitable therapeutic scheme to reduce the risk of disease progression towards respiratory failure in paucisymptomatic patients affected by SARS-CoV-2 infection treated at home

Identificare lo schema terapeutico dei pazienti paucisintomatici con infezione da SARS-CoV-2 trattati a domicilio più idoneo a ridurre il rischio di progressione della malattia verso l’insufficienza respiratoria

E.2.2

Secondary objectives of the trial

• Assess the frequency of hospitalizations in the 3 treatment arms
• Evaluate the frequency of nasopharyngeal swab positive patients at the end of the experimental treatment in the 3 treatment arms
• Compare safety and tolerability associated with therapeutic regimens proposed in paucisymptomatic patients with SARS-CoV-2 infection treated at home; for patients on treatment with heparins, evaluate the onset of vascular disorders

• Valutare la frequenza delle ospedalizzazioni nei 3 bracci di trattamento
• Valutare la frequenza di pazienti positivi al tampone naso-faringeo alla fine del trattamento sperimentale nei 3 bracci di trattamento
• Confrontare sicurezza e tollerabilità associate agli schemi terapeutici proposti in pazienti con infezione da SARS-CoV-2 paucisintomatici trattati a domicilio; per i pazienti con trattamento eparinico, valutare l'insorgenza di disordini vascolari

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age from 35 to 80 years
2. Confirmed SARS-CoV-2 infection, (evidence of infection obtained by COVID-19 swab test prior to consent signing is accepted)
3. Patients with mild / moderate symptoms with at least fever and / or painful manifestations such as headache, muscle aches, sore throat, and in addition vomiting and/or diarrhea.
4. Signing informed consent
5. For female patients: statement of menopausal status or absence of pregnancy

1. Età compresa tra 35 e 80 anni
2. Infezione confermata da SARS-CoV-2 (Allegato 1), (si accetta evidenza di infezione ottenuta con tampone precedente la firma del consenso)
3. Pazienti con sintomatologia lieve/moderata (vedere Allegato 3 del protocollo per le definizioni), con almeno febbre e/o manifestazioni dolorose come mal di testa, dolori muscolari, mal di gola a cui possono aggiungersi vomito e/o diarrea
4. Firma del consenso informato
5. Per le pazienti di sesso femminile: dichiarazione di stato menopausale o assenza di gravidanza

E.4

Principal exclusion criteria

1. Age less than 35 years old
2. 80 years old in the year of enrollment
3. Clinical condition requiring steroid therapy
4. Mechanical ventilation needed
5. Pregnancy and breastfeeding
6. Severe electrolyte imbalances
7. History of ventricular cardiac arrhythmias
8. Known renal insufficiency (CcCl <30 mL / min or patient on CCRT, haemodialysis or peritoneal dialysis)
9. Oncological, haemato-oncological, haematological and / or hepatic disease
10. Retinal disease, or hearing loss
11. Mental illness
12. Skin disorders (including skin rash, dermatitis, psoriasis)
13. Patients already on anticoagulant treatment with high / low molecular weight heparins or other parenteral anticoagulants
14. Patients at high venous thromboembolic risk according to the Padua score already on prophylaxis with low molecular weight heparin or unfractionated heparin
15. Patients with indications for treatment with oral anticoagulants
16. Patients on chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
17. Patients being treated with antivirals
18. Patients treated with monoclonal antibodies with direct action on cytokines
19. Patients being treated with chloroquine / hydroxychloroquine
20. Intolerance to study drugs
21. Immunosuppressive therapy in progress or in the last month.
22. Patients with severe hepatocellular insufficiency
23. Patients with ulcerative colitis or Crohn's disease
24. Patients with increased bleeding risk:
• Congenital and acquired haemorrhagic diseases
• Thrombocytopenia (<25,000 / mm3)
• Bleeding in progress
• Previous heparin thrombocytopenia
25. Women of childbearing age who do not use contraceptives
26. Participation in other interventional or observational clinical trials

1. Età inferiore 35 anni (compiuti)
2. Età superiore a 80 anni (anche se non compiuti)
3. Quadro clinico che richiede terapia steroidea
4. Necessità di ventilazione meccanica
5. Gravidanza e allattamento
6. Presenza di gravi scompensi elettrolitici
7. Storia di aritmie cardiache ventricolari
8. Insufficienza renale nota (CcCl <30 mL/min o paziente in CCRT, emodialisi o dialisi peritoneale)
9. Malattia oncologica, emato-oncologica, ematologica e/o epatica
10. Malattia retinica, o perdita dell'udito
11. Malattia mentale
12. Disturbi della pelle (inclusi rash cutaneo, dermatite, psoriasi)
13. Pazienti già in trattamento anticoagulante
14. Pazienti ad elevato rischio tromboembolico venoso secondo il Padua score (Allegato7) già in profilassi con eparina a basso peso molecolare o eparina non frazionata
15. Pazienti con indicazioni al trattamento con anticoagulanti orali
16. Pazienti in trattamento cronico con farmaci antinfiammatori non steroidei (FANS)
17. Pazienti in trattamento con antivirali
18. Pazienti in trattamento con anticorpi monoclonali con azione diretta su citochine
19. Pazienti in trattamento con clorochina/idrossiclorochina
20. Intolleranza ai farmaci in studio
21. Terapia immunosoppressiva in corso o nell’ultimo mese.
22. Pazienti con grave insufficienza epatocellulare
23. Pazienti affetti da colite ulcerosa o da morbo di Crohn
24. Pazienti con aumentato rischio emorragico:
• Malattie emorragiche congenite e acquisite
• Piastrinopenia (<25.000/mm3)
• Emorragia in atto
• Precedente piastrinopenia da eparina
25. Donne in età fertile che non fanno uso di contraccettivi
26. Partecipazione ad altri studi clinici interventistici e/o osservazionali

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients with worsening of disease symptoms and signs 5-10 (±2) days after initiation of therapy (baseline), i.e. transition from mild to moderate or severe or critical disease, or from moderate to severe disease criticism.

Percentuale di pazienti che a 5 e 10 (±2) giorni dall’inizio della terapia farmacologica (basale) presenta sintomi e segni di malattia peggiorati rispetto a quelli registrati al basale, ovvero che transitano da malattia lieve a moderata o severa o critica, oppure da malattia moderata a severa o critica

E.5.1.1

Timepoint(s) of evaluation of this end point

5 and 10 (±2) days

5 e 10 (±2) giorni

E.5.2

Secondary end point(s)

• Percentage of patients hospitalized within 5 and 10 (±2) days of the start of therapy (baseline) in the 3 treatment arms; • Percentage of patients positive for nasopharyngeal swab at 10 (± 2) days from the start of treatment; • Grade 2-5 treatment-related adverse events (moderate, severe, very severe related events and deaths), serious adverse events or treatment discontinuation due to toxicity in the 3 treatment arms (safety and tolerability)

• Percentuale di pazienti ospedalizzati entro 5 e 10 (±2) giorni dall’inizio della terapia farmacologica (basale) nei 3 bracci di trattamento; • Percentuale di pazienti positivi al tampone naso-faringeo a 10 (±2) giorni dall’inizio del trattamento; • Eventi avversi correlati ai trattamenti di grado 2-5 (eventi correlati moderati, severi, molto severi e decessi), eventi avversi seri o interruzioni del trattamento dovute a tossicità nei 3 bracci di trattamento (sicurezza e tollerabilità)

E.5.2.1

Timepoint(s) of evaluation of this end point

5 and 10 (±2) days; 10 (±2) days; 15 days

5 e 10 (±2) giorni; 10 (±2) giorni; 15 giorni

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

E.6.4

Safety

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Adattivo, multi-braccio, multi-stadio, randomizzato a grappolo

Adaptive, multi-arm, multi-stage, cluster randomised

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

Yes

E.8.2.3.1

Comparator description

Paracetamolo in monoterapia

Paracetamol alone, not in combination with other IMPs

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

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

Information not present in EudraCT

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

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:

570

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

240

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

810

F.4.2

For a multinational trial

F.4.2.1

In the EEA

810

F.4.2.2

In the whole clinical trial

810

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)

No specific program. Each patient will be normally assisted by his/her General Practitioner

Nessun programma specifico. Ogni paziente sarà ordinariamente assistito dal suo Medico di Medicina Generale

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

2021-04-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-12

P. End of Trial
P.	End of Trial Status	Prematurely Ended

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials