Clinical Trials Register

Summary
EudraCT Number:	2020-001435-27
Sponsor's Protocol Code Number:	CHUBX2020/12
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-04-01
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

France - ANSM

A.2

EudraCT number

2020-001435-27

A.3

Full title of the trial

Home treatment of elderly patients with symptomatic SARS-CoV-2 infection (COVID-19) : a multiarm, multi-stage (MAMS) randomized trial to assess the efficacy and safety
of several experimental treatments to reduce the risk of hospitalization or death
(COVERAGE trial)

Traitement à domicile des personnes âgées présentant une infection symptomatique à SARS-CoV-2 (COVID-19) : un essai randomisé multi-bras multi-étapes (MAMS) pour évaluer l'efficacité et la tolérance de plusieurs traitements expérimentaux afin de diminuer le risque d'hospitalisation ou de décès

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

COVERAGE

A.4.1

Sponsor's protocol code number

CHUBX2020/12

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04356495

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	CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC
B.1.3.4	Country	France
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	Ministry oh health - DGS
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC
B.5.2	Functional name of contact point	REC
B.5.3	Address:
B.5.3.1	Street Address	12 rue dubernat
B.5.3.2	Town/ city	TALENCE
B.5.3.3	Post code	33404
B.5.3.4	Country	France
B.5.4	Telephone number	+33057820334
B.5.6	E-mail	patrick.cassai@chu-bordeaux.fr

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	Yes
D.2.1.1.1	Trade name	Imatinib Teva 400 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	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	IMATINIB
D.3.9.1	CAS number	152459-95-5
D.3.9.3	Other descriptive name	IMATINIB
D.3.9.4	EV Substance Code	SUB25387
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	400
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	AVIGAN 200mg
D.2.1.1.2	Name of the Marketing Authorisation holder	FUJIFILM Pharmaceuticals
D.2.1.2	Country which granted the Marketing Authorisation	Japan
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.3.4	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	FAVIPIRAVIR
D.3.9.3	Other descriptive name	FAVIPIRAVIR
D.3.9.4	EV Substance Code	SUB194303
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 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.2.1.1.1	Trade name	MICARDIS 20mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim International GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	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	TELMISARTAN
D.3.9.1	CAS number	144701-48-4
D.3.9.4	EV Substance Code	SUB10874MIG
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	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

severe acute respiratory syndrome coronavirus 2(SARS-CoV 2)

coronavirus 2 du syndrome respiratoire aigu sévère

E.1.1.1

Medical condition in easily understood language

severe acute respiratory syndrome coronavirus 2(SARS-CoV 2)

coronavirus 2 du syndrome respiratoire aigu sévère

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

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 main objective of this trial is To estimate the efficacy of several specific experimental treatments, compared to standard care, to prevent hospitalization or death at D14 in adults over 65 years of age, with documented SARS-CoV-2 infection, with symptoms lasting less than 72 hours and not meeting any hospitalization criteria.

L'objectif principal est d'estimer l'efficacité de plusieurs traitements expérimentaux spécifiques, comparé au soins standard, pour prévenir l'hospitalisation ou le décès à J14 chez les adultes de plus de 65 ans, atteints d'une infection documentée par le SRAS-CoV-2, présentant des symptômes pendant moins de 72 heures et ne répondant à aucun critère d'hospitalisation

E.2.2

Secondary objectives of the trial

To estimate :
- the effectiveness of experimental treatments against SARS-CoV-2, to prevent death on D28
- the effectiveness of experimental treatments against SARS-CoV-2, to prevent hospitalization on D28
- the effectiveness of experimental treatments against SARS-CoV-2, compared to standard care, to prevent hospitalization in intensive care on D28
- the effectiveness of experimental treatments against SARS-CoV-2 to suppress nasopharyngeal viral carriage, compared to standard care
- the effectiveness of experimental treatments against SARS-CoV-2, compared to standard care, to prevent a loss of autonomy on D14 and D28
- the tolerance of experimental treatments against SARS-CoV-2
- Study the factors associated with the worsening of the disease
- Evaluate the feasibility and acceptability of the trial and the care model implemented
- Assess the relationship between the concentration of each drug and the effectiveness of each treatment

Estimer :
- l'efficacité de traitements expérimentaux contre le SARS-CoV-2, pour prévenir le décès à J28
- l'efficacité de traitements expérimentaux contre le SARS-CoV-2, pour prévenir l’hospitalisation à J28
- l'efficacité de traitements expérimentaux contre le SARS-CoV-2, comparé aux soins standard, pour prévenir l’hospitalisation en soins intensifs à J28
- l'efficacité de traitements expérimentaux contre le SARS-CoV-2 pour supprimer le portage viral nasopharyngé, comparé aux soins standard
- l'efficacité de traitements expérimentaux contre le SRAS-CoV-2, comparé aux soins standard, pour prévenir une perte d’autonomie à J14 et J28
- la tolérance des traitements expérimentaux contre le SARS-CoV-2
- Etudier les facteurs associés à l'aggravation de la maladie
- Évaluer la faisabilité et l'acceptabilité de l'essai et du modèle de soins mis en œuvre
- Évaluer la relation entre concentration de chaque médicament et l'efficacité de chacun des traitements

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

An immunological sub-study will be carried out with 3 objectives:
- assess the impact of drugs on immunological parameters.
- identify the immune biomarkers associated with the clinical worsening of the disease.
- identify the immune biomarkers associated with a change in the effect of the interventions evaluated.

une sous étude immunologique sera réalisée avec 3 objectifs :
‒ évaluer l'impact des médicaments sur les paramètres immunologiques.
‒ identifier les biomarqueurs immunitaires associés à l'aggravation clinique de la maladie.
‒ identifier les biomarqueurs immunitaires associés à une modification de l’effet des interventions évaluées.

E.3

Principal inclusion criteria

‒ Positive SARS-CoV-2 test on nasopharyngeal swab
‒ Onset of symptoms < 5 days prior to nasopharyngeal swabbing
‒ Age ≥ 60 years old
‒ Valid, ambulatory person, fully capable of understanding the challenges of the trial
‒ No hospitalization criteria according to current recommendations
‒ Signed informed consent
‒ Covered by Health Insurance

‒ Test SARS-CoV-2 positif sur prélèvement nasopharyngé
‒ Apparition des symptômes < 5 jours avant la réalisation du prélèvement nasopharyngé
‒ Âge ≥ 60 ans
‒ Personne valide, ambulatoire, en pleine capacité de comprendre les enjeux de l'essai
‒ Pas de critères d'hospitalisation selon les recommandations en cours
‒ Consentement éclairé signé
‒ Affilié(e) ou bénéficiaire d’un régime de la Sécurité Sociale

E.4

Principal exclusion criteria

‒ Inability to make a decision to participate (dementia, guardianship)
‒ Long QT syndrome, or QTc space > 500 ms
‒ Heart rate <50 / min
‒ Hyperkalemia > 5.5 mmol/L or hypokalemia < 3.5 mmol/L
‒ Treatment with dasatinib, nilotinib, ibrutinib, , potent inhibitors of cytochrome P450 CYP3A4 isoenzyme, potent inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin.
‒ Hypersensitivity to any of the trial drugs, , ARA2 or sartan.
‒ Liver failure (stage ≥ Child-Pugh B), stage 4 or 5 chronic kidney disease (DFG <30 mL/min/1.73 m²), person on dialysis, malabsorption syndrome, symptomatic gout/hyperuricemia, ileus, colitis or enterocolitis, chronic infection with the hepatitis B virus.

‒ Incapacité à prendre une décision de participation (démence, tutelle)
‒ Syndrome du QT long connu, ou espace QTc > 500 ms
‒ Fréquence cardiaque <50/mn
‒ Hyperkaliémie >5,5 mmol/L ou hypokaliémie <3,5 mmol/L
‒ Traitement par dasatinib, nilotinib, ibrutinib, inhibiteurs puissants de l'isoenzyme CYP3A4 du cytochrome P450, inducteurs puissants de l'isoenzyme CYP3A4 du cytochrome P450, répaglinide, l’azathioprine, la 6-mercapto-purine, théophylline, pyrazinamide, warfarine.
‒ Hypersensibilité à l’un des médicaments de l'essai, aux ARA2 ou aux sartans.
‒ Insuffisance hépatique (stade ≥ Child-Pugh B), maladie rénale chronique stade 4 ou 5 (DFG <30 mL/min/1,73 m²), personne en dialyse, syndrome de malabsorption, goutte/hyperuricémie symptomatique, iléus, colite ou entérocolite, infection chronique par le virus de l'hépatite B.

E.5 End points

E.5.1

Primary end point(s)

Proportion of participants with an occurrence of hospitalization and/or death between D0 and D14 in each arm

Proportion de participants avec une survenue d’'hospitalisation et/ou décès entre J0 et J14 dans chaque bras

E.5.1.1

Timepoint(s) of evaluation of this end point

day 14 after inclusion

14 jours après l'inclusion

E.5.2

Secondary end point(s)

The analyzes on the secondary endpoints, with the exception of the toxicity results, will be carried out with the intention of treating on the available data

Les analyses sur les critères de jugement secondaires, à l'exception des résultats de toxicité, seront effectuées en intention de traiter sur les données disponibles

E.5.2.1

Timepoint(s) of evaluation of this end point

day 28 after inclusion

28 jours après l'inclusion

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

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

AZINC FORME ET VITALITE

AZINC FORME ET VITALITE (vitamins supplements)

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

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

dernière visite du dernier patient

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

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

1057

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

845

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Aucun

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

2020-04-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-10-22

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