ICH GCP - EU Clinical trials Registry

Clinical Trial Page

Summary
EudraCT Number:	2021-000492-36
Sponsor's Protocol Code Number:	HOPECOVID-19
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2021-04-21
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

A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2021-000492-36

A.3

Full title of the trial

Home and Outpatients Precocious Eradication of COVID-19

A.3.1

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

Home and Outpatients Precocious Eradication of COVID-19

A.3.2

Name or abbreviated title of the trial where available

HOPE COVID-19

A.4.1

Sponsor's protocol code number

HOPECOVID-19

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	UCLouvain
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Centre Académique de Médecine Générale (CAMG), UCLouvain, Belgium
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Centre académique de médecine générale
B.5.2	Functional name of contact point

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	Siroxyl sans sucre pour adultes 750 mg/15ml solution buvable
D.2.1.1.2	Name of the Marketing Authorisation holder	MELISANA N.V
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Oral solution
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	carbocysteine
D.3.9.1	CAS number	638-23-3
D.3.9.2	Current sponsor code	HOPE-01-V
D.3.9.3	Other descriptive name	CARBOCISTEINE LYSINE
D.3.9.4	EV Substance Code	SUB01046MIG
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	750
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Syrup
D.8.4	Route of administration of the placebo	Oral 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

COVID-19

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	10084382
E.1.2	Term	Coronavirus disease 2019
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Rate, in percent, of subjects in each investigation arm displaying a SARS-CoV-2 RT-PCR Ct count above 34 (>34 cycles) performed on a saliva sample collected at Day 6 of experiment, after full treatment completion.

E.2.2

Secondary objectives of the trial

1)Clinical evolution based on the daily filling of the FLU-PRO self-questionnaire (daily comparison of the distribution and mean of FLU-PRO score in each investigation arm)
2)Rate of subjects in each investigation arm displaying a negative viral culture of a nasopharyngeal swab sample collected at Day 3 of experiment
3)Median time, in days, of viral shedding in the subjects in each investigation arm (time of viral shedding=nb of days in experiment of a saliva sample which RT-PCR Ct count is >34)
4)Evolution of the daily distribution and mean RT-PCR Ct count compared between the two investigation arms, performed on saliva samples collected daily in all the subjects, from Day 1 to Day 6
5)Rate of subjects in each investigation arm having reported any kind of adverse events and reactions including specific comparison according to :
- the organic system they affect, be it encompassed by the table in Appendix 2 or not ;
- their quality and severity class : AE, SAE, SUSAR

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Provided informed consent following an exhaustive and fully-understood information
-Aged ≥16 years and ≤65 years
-Does not present any criteria of redirection towards the Emergency Room or towards a direct hospitalization
-Time from symptom onset (TFSO) ≤48 hours AND tested positive at the Rapid Antigenic Test

E.4

Principal exclusion criteria

-Pregnancy, breastfeeding, or any woman of child-bearing potential that does not benefit from any proper contraception and whose Last Menstrual Period occurred 20 days ago or more (≥ 20 days).
-Immunosuppression, whatever the type, including drug-induced cases.
-COVID-19 requiring hospitalization or redirection towards the Emergency Room.
-Anti-COVID-19 vaccination, whatever the vaccine, as soon as first dose has been administered.
-Former COVID-19 infection diagnosed upon positive SARS-CoV-2 RT-PCR test results.

E.5 End points

E.5.1

Primary end point(s)

Rate, in percent, of subjects in each investigation arm displaying a SARS-CoV-2 RT-PCR Ct count above 34 (>34 cycles) performed on a saliva sample collected at Day 6 of experiment

E.5.1.1

Timepoint(s) of evaluation of this end point

after full treatment completion

E.5.2

Secondary end point(s)

1)Clinical evolution based on the daily filling of the FLU-PRO self-questionnaire, defined by daily comparison (up to and including Day 10 of experiment) of the distribution and mean of FLU-PRO score in each investigation arm, in points.

2)Rate, in percent, of subjects in each investigation arm displaying a negative viral culture (impossibility to cultivate SARS-CoV-2, see Section 7 for methodology) of a nasopharyngeal swab sample collected at Day 3 of experiment.

3)Median time, in days, of viral shedding in the subjects in each investigation arm ; time of viral shedding being defined as the number of days in experiment (starting Day 1) up to and not including the first Day of collection of a saliva sample which RT-PCR Ct count is above 34 (>34).

4)Evolution of the daily distribution and mean RT-PCR Ct count, in number of cycles, compared between the two investigation arms, performed on saliva samples collected daily in all the subjects, from Day 1 included to Day 6 included.

5)Rate, in percent, of subjects in each investigation arm having reported any kind of adverse events and reactions, either spontaneously or via prospective adverse event investigation (by daily phone calls of the Study Nurse), including specific comparison according to :
- the organic system they affect, be it encompassed by the table in Appendix 2 or not ;
- their quality and severity class : Adverse Event (AE), Severe Adverse Event (SAE), Suspected Unexpected Serious Adverse Reaction (SUSAR).

E.5.2.1

Timepoint(s) of evaluation of this end point

1)up to and including Day 10 of experiment
2)at Day 3 of experiment
3)from Day 1 to Day 6
4)from Day 1 to Day 6
5)from Day 1 to Day 10

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

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

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

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:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-04-21.

Yes

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

104

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)

After leaving the trial on day 11, the patient will be cared for by his general practicionner,
which will be provided with all relevant clinical informations that might have been noticed during the trial.

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

2021-04-27

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status

Clinical Trial Page

Sponsors and Collaborators

Medical Conditions

Drug Interventions