Clinical Trials Register

Summary
EudraCT Number:	2021-004035-88
Sponsor's Protocol Code Number:	AntiCov
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-08-26
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-004035-88

A.3

Full title of the trial

A randomized, open-label, active controlled, parallel group, multicenter phase 3 study to evaluate the efficacy and tolerability of Bamlanivimab and Etesevimab, Casirivimab and Imdevimab, and Sotrovimab versus Standard of Care in patients with mild to moderate COVID-19 disease (AntiCov)

A.3.1

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

Phase III clinical trial with monoclonal antibodies versus standard of care for the treatment of early-stage COVID-19

Studio clinico di fase III con anticorpi monoclonali contro lo standard di cura per il trattamento della COVID-19 allo stadio iniziale

A.3.2

Name or abbreviated title of the trial where available

AntiCov

A.4.1

Sponsor's protocol code number

AntiCov

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 POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
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	AIFA - Italian Medicines Agency
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FONDAZIONE POLICLINICO UNIOVERSITARIO AGOSTINO GEMELLI UNIVERSITA CATTOLICA DEL SACRO CUORE
B.5.2	Functional name of contact point	U.O.C PNEUMOLOGIA
B.5.3	Address:
B.5.3.1	Street Address	VIA LARGO FRANCESCO VITO 1
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390630155701
B.5.5	Fax number	+390630155701
B.5.6	E-mail	luca.richeldi@policlinicogemelli.it

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.2.1.1.1	Trade name	SOTROVIMAB
D.2.1.1.2	Name of the Marketing Authorisation holder	SOTROVIMAB
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	SOTROVIMAB
D.3.2	Product code	[SOTROVIMAB]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	SOTROVIMAB
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	62
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.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	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BAMLANIVIMAB
D.3.2	Product code	[BAMLANIVIMAB]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Bamlanivimab
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	35
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.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	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	imdevimab
D.3.2	Product code	[imdevimab]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	imdevimab
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	120
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.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	No
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Etesevimab
D.3.2	Product code	[Etesevimab]
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Etesevimab
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	35
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.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	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	casirivimab
D.3.2	Product code	[casirivimab]
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	Casirivimab
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	120
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with mild to moderate SARS-COV-2 infection.

Pazienti affetti da infezione SARS-COV-2 da lieve a moderata.

E.1.1.1

Medical condition in easily understood language

Use of monoclonal antibodies vs standard of care for the treatment of early stage SARS-COV-2 infection at high risk of progression to severe COVID-19 (according to AIFA criteria).

Uso di anticorpi monoclonali vs lo standard of care per il trattamento dell'infezione da SARS-COV-2 in fase precoce, ad alto rischio di progressione a COVID-19 severa (secondo criteri AIFA)

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

The primary objective of the study is:
- To assess the efficacy of monoclonal antibodies (Bamlanivimab/Etesevimab, Casirivimab/Imdevimab, Sotrovimab) in patients with COVID-19 by looking at disease progression in terms of hospitalization in intensive care unit, oxygen desaturation =4% and peripheral oxygen saturation =92% during the follow-up period (30 days).

L'Obiettivo primario dello studio è il seguente:
- valutare l'efficacia degli anticorpi monoclonali (Bamlanivimab/Etesevimab, Casirivimab/Imdevimab, Sotrovimab) in pazienti affetti da COVID-19, osservando la progressione della malattia in termini di ospedalizzazioni nelle unità di terapia intensiva, desaturazione dell'ossigeno =4% e saturazione dell'ossigeno =92% durante il periodo di follow-up (30 giorni)

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are:
- To assess the impact of experimental drugs on safety and tolerability during the 30-day follow-up period,
- To assess the impact of experimental drugs on survival during the 30-day follow-up period.

Gli Obiettivi Secondari dello studio sono:
- Valutare sicurezza e tollerabilità dei trattamenti di studio nel periodo di follow-up (30 giorni)
- Verificare la riduzione della mortalità a 30 giorni dalla positività per SARS-Cov-2

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Signed Informed Consent Form
2. Men or non-pregnant women =12 years of age at the time of randomization
3. Agree to the collection of nasopharyngeal swabs
4. Patients currently not hospitalized
5. Have one or more mild or moderate COVID-19 symptoms such as fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath
6. Must have sample collection for first positive SARS-CoV-2 viral infection
7. High risk for severe COVID-19 disease defined as the presence of one or more of the following conditions: age=65 years, BMI=30 kg/m2, chronic kidney disease, chronic lung diseases, including COPD (chronic obstructive pulmonary disease), asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension, diabetes, heart conditions (such as heart failure, coronary artery disease, cardiomyopathies or hypertension), immunocompromised state, liver disease, stroke or cerebrovascular disease.

1. Adulti e adolescenti di età pari o superiore a 12 anni che non necessitano di ossigenoterapia supplementare per COVID-19 e che sono ad alto rischio di progressione a COVID-19 severa definito dalla presenza di almeno uno dei seguenti criteri:
2. Aver firmato il Consenso informato
3. Uomini o Donne non in stato di gravidanza, di età =12 anni
4. Acconsentire alla raccolta di un campione tramite tampone noasofaringeo
5. Pazienti non ospedalizzati
7. Avere uno o più sintomi COVID-1, di entità lieve o moderata, quali febbre, tosse, mal di gola, malessere, mal di testa, dolori muscolari, sintomi di natura gastointestinale, o respiro corto
6. Avere un campione di positività per l’infezione virale SARS-CoV-2
7. Essere ad alto rischio di sindrome COVID-19 severa, definita con la presenza di una o più delle condizioni che seguono: età =65 anni; BMI=30 kg/m2; malattia renale cronica; malattia polmonare cronica, che include BPCO (BroncoPneumopatia Cronica Ostruttiva), asma (moderata o severa), interstiziopatia polmonare, fibrosi cistica, ipertensione polmonare; diabete; problemi cardiaci (come insufficienza cardiaca, coronaropatia, cardiomiopatie o ipertensione), stato di immunocompromissione; malattie epatiche; ictus o malattie cerebrovascolari.

E.4

Principal exclusion criteria

1. Have SpO2 =92% on room air at sea level or PaO2/FiO2 <300
2. Respiratory rate =30 per minute
3. Heart rate =125 per minute
4. Hospitalized for COVID-19 disease
5. Respiratory failure secondary to COVID-19 disease
6. Have known allergies to any of the components used in the formulation of the interventions
7. Have hemodynamic instability
8. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
9. Have any comorbidity requiring surgery within 7 days, or that is considered life-threatening within 29 days
10. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study
11. Have a history of a positive SARS-CoV-2 serology test
12. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing (Anti-COVID-19 vaccines are allowed)
13. Have received treatment with a SARS-CoV-2 specific monoclonal antibody
14. Have a history of convalescent COVID-19 plasma treatment
15. Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
16. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
17. Are pregnant or breast feeding.

1. Avere una saturazione SpO2 =92% o PaO2/FiO2 <300
2. Frequenza respiratoria =30 al minuto
3. Frequenza cardiaca =125 al minuto
4. Ricovero in ospedale per malattia COVID-19
5. Insufficienza respiratoria secondaria dovuta al COVID-19
6. Avere note allergie ad uno qualsiasi dei componenti utilizzati nella formulazione degli interventi
7. instabilità emodinamica
8. Sospetta o dimostrata grave infezione batterica, fungina, virale o di altro tipo (oltre a COVID-19) che a parere dello sperimentatore potrebbe costituire un rischio durante l'intervento
9. Avere qualsiasi comorbilità che richieda un intervento chirurgico entro 7 giorni o che sia considerata pericolosa per la vita entro 29 giorni
10. Avere qualsiasi malattia, condizione o disturbo sistemico concomitante grave che, a parere dello sperimentatore, dovrebbe precludere la partecipazione a questo studio
11. Avere nel passato un test sierologico SARS-CoV-2 positivo
12. Aver ricevuto un intervento sperimentale per la profilassi SARS-CoV-2 entro 30 giorni prima della somministrazione (sono consentiti i vaccini anti-COVID-19)
13. Aver ricevuto un trattamento con un anticorpo monoclonale specifico per SARS-CoV-2
14. Avere una storia di trattamento al plasma COVID-19 convalescente
15. Aver partecipato, negli ultimi 30 giorni, a uno studio clinico che prevedesse un intervento sperimentale. Se il precedente intervento sperimentale ha una lunga emivita, pari a 5 emivite o 30 giorni, a seconda di quale sia più lungo, dovrebbe essere trascorso il tempo necessario
16. Sono contemporaneamente iscritti a qualsiasi altro tipo di ricerca medica giudicata compatibile a livello medico o scientifico con questo studio
17. Donna incinta o in allattamento.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of the study is:
- Disease progression defined as: hospitalization in intensive care unit, oxygen desaturation =4% and peripheral oxygen saturation =92% during the follow-up period (30 days).

Endpoint Primario:
- Progressione della malattia definita come: ricovero in unità di terapia intensiva, desaturazione di ossigeno =4% e saturazione di ossigeno periferica =92% durante il periodo di follow-up (30 giorni).

E.5.1.1

Timepoint(s) of evaluation of this end point

Timepoint are reported within the endpoint list

Tempi di rilevazione indicati all'interno dei punti finali

E.5.2

Secondary end point(s)

The secondary endpoints of the study are:
- Incidence and severity of adverse events, with severity determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0]) during the follow-up period (30 days).
- Proportion of patients admitted to the Emergency Department for COVID-19 disease during the follow-up period.
- All-cause mortality due to COVID-19 disease.

Endpoint Secondari:
- Incidenza e gravità degli eventi avversi (AE), con gravità determinata secondo la scala di gravità a 5 punti (National Cancer Institute Common Terminology Criteria for Adverse Events, Versione 5.0 [NCI CTCAE, v.5.0]) durante il periodo di follow-up (30 giorni)
- Percentuale di pazienti ricoverati in Pronto Soccorso per malattia COVID-19 durante il periodo di follow-up
Mortalità per tutte le cause a causa della malattia COVID-19

E.5.2.1

Timepoint(s) of evaluation of this end point

Timepoint are reported within the endpoint list

Tempi di rilevazione indicati all'interno dei punti finali

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

Yes

E.6.13.1

Other scope of the trial description

tolerability

tollerabilità

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

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

SOC (standard di cura) quali paracetamolo o FANS, per la gestione domiciliare del COVID-19

SOC (standard of care) as Paracetamol or FANS for home management of COVID-19

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

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

Yes

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

400

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

400

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

400

F.4.2

For a multinational trial

F.4.2.1

In the EEA

400

F.4.2.2

In the whole clinical trial

400

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)

not expected

non previsto

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

2021-08-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-11-18

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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