Clinical Trials Register

Summary
EudraCT Number:	2021-000045-41
Sponsor's Protocol Code Number:	TEE001DP-01
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:	2021-04-12
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

2021-000045-41

A.3

Full title of the trial

Adaptive, Ambulatory, Randomised, Placebo-Controlled, Double-Blind, Phase 2/3 Study to Evaluate the Safety, Tolerability, and Efficacy of TEE001DP in Patients at the Early Stage of Symptomatic COVID-19

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

THERAPIDE

A.4.1

Sponsor's protocol code number

TEE001DP-01

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	Institut Pasteur de Lille
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	Institut Pasteur de Lille
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	Institut Pasteur de Lille
B.5.2	Functional name of contact point	Benoit Déprez
B.5.3	Address:
B.5.3.1	Street Address	1 Rue du Professeur Calmette
B.5.3.2	Town/ city	Lille
B.5.3.3	Post code	59000
B.5.3.4	Country	France
B.5.4	Telephone number	33685460872
B.5.6	E-mail	benoit.deprez@univ-lille.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	Gramplus® 750mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Chiesi Farmaceutici S.p.A.
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.3.2	Product code	TEE001DP
D.3.4	Pharmaceutical form	Suppository
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Rectal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLOFOCTOL
D.3.9.1	CAS number	37693-01-9
D.3.9.4	EV Substance Code	SUB06711MIG
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	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	Suppository
D.8.4	Route of administration of the placebo	Rectal 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] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10084401
E.1.2	Term	COVID-19 respiratory infection
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

To assess the efficacy of TEE001DP versus placebo on the improvement of patient’s clinical status.

E.2.2

Secondary objectives of the trial

Safety:
- To assess the safety of TEE001DP versus placebo
Virological:
- To compare the evolution of viral load between treatment groups.
- To assess the impact of initial viral load on treatment efficacy in both treatment groups.
Clinical:
- To assess the efficacy of TEE001DP versus placebo on the short-term evolution of clinical signs and symptoms of COVID-19 and on the patient’s full recovery.
- To compare the use of paracetamol or other standard-of-care treatments for the management of COVID-19 symptoms between treatment groups.
Oximetric:
- To compare the time to occurrence of oxygen saturation (SpO2) ≤93% between treatment groups.
Other:
- To compare patient treatment compliance between treatment groups.
- To describe patient treatment acceptability regarding the suppository form in both treatment groups.
Exploratory:
To compare the evolution of viral load between treatment groups for patients who consented to having a third optional virological test.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Positive SARS-CoV-2 test results within the last 72 hours (obtained using either nasopharyngeal, saliva, or throat samples, by either reverse transcriptase-polymerase chain reaction [RT-PCR] or antigen technic).
2. An onset of any clinical signs and symptoms suggestive of COVID-19 disease (eg, headaches, sore throat, myalgia, fatigue, fever >38°C, nasal congestion, rhinorrhoea, sneezing, cough, anosmia-or-ageusia), with at least one clinical signs and symptoms starting within the last 72 hours.
3. Non-hospitalised patient.
4. Adult male or female patients ≥50 years of age.
5. Willing to comply with all study procedures.
6. Able to understand and willing to provide informed consent.
7. For females only: At the time of enrolment, negative beta-human chorionic gonadotropin pregnancy test (urine) for women of childbearing potential.
8. Patient covered by health insurance during the study period.

E.4

Principal exclusion criteria

1. Known history of allergic reactions to clofoctol or any of the excipients.
2. Known history of previous severe allergic reactions as anaphylaxis or Stevens-Johnson syndrome whatever the cause.
3. Active and persistent diarrhoea, defined as 3 or more loose or watery stools per day for more than 48 hours.
4. SpO2 ≤93%.
5. Score of 3 in any individual parameter of the National Early Warning Score, ie:
a. Respiratory distress with respiratory rate ≥25 or ≤8 breaths/minute;
b. Oral body temperature ≤35°C;
c. Systolic blood pressure ≤90 or ≥220 mmHg;
d. Heart rate ≤40 or ≥131 beats/minute.
6. Critically ill patients presenting with 1 of the following:
a. Respiratory failure requiring to receive mechanical ventilation;
b. Shock.
7. Pregnant or breastfeeding female patients. Women of childbearing potential should have a negative pregnancy test and agree to use a highly effective contraceptive method during the study (eg, oral contraceptive and condom, intra-uterine device and condom, diaphragm with spermicide and condom) and for up to 5 half-lives after the last investigational product (IP) administration.
8. Current participation in another interventional clinical study or participation in another interventional clinical study within 1 month prior to the first dose of IP in this study.
9. Patients having received 1 or more doses of vaccine against SARS-CoV-2.
10. Incarcerated patient.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is treatment failure rate in each treatment group, treatment failure being defined at Day 22 as:
1. Occurrence of SpO2 ≤93% within 10 days after Day 0; and/or
2. Use of home oxygen therapy within 22 days after Day 0; and/or
3. Unscheduled hospitalisation of more than 24 hours related to the infection within 22 days after Day 0.

E.5.1.1

Timepoint(s) of evaluation of this end point

D22

E.5.2

Secondary end point(s)

Safety Endpoint:
1. Rate of patients who experienced an adverse event (all types/grades) within 22 days after Day 0.
Virological Endpoints:
2. Between treatment group difference in the viral load change from Day 0 to Day 3.
3. Relationship between initial viral load and treatment failure rate.
Clinical Endpoints:
4. Proportion of patients with 50% decrease in the composite clinical score at Day 10 and the area under the curve of the composite clinical score curve from Day 0 to Day 10.
5. Proportion of patients reaching null composite clinical score from Day 0 to Day 10 in each treatment group.
6. Proportion of patients taking paracetamol or other standard-of-care treatments for the management of COVID-19 symptoms from Day 0 to Day 5 in each treatment group.
Oximetric Endpoint:
7. Time from Day 0 to SpO2 ≤93% until Day 10 in each treatment group.
other Endpoints:
8. Proportion of patients with 100% treatment compliance at Day 5 in each treatment group.
9. Proportion of patients indicating that the suppository form affected treatment compliance in both treatment groups.
Exploratory Endpoint:
10. Between treatment group difference in the viral load change from Day 0 to Day 7 in the subgroup of patients who consented to having a third optional virological test.

E.5.2.1

Timepoint(s) of evaluation of this end point

Safety Endpoint: D22
Virological Endpoint: from Day 0 to Day 3
Clinical Endpoints: from Day 0 to Day 10 and from Day 0 to Day 5 for paracetamol
Oximetric Endpoint: from Day 0 to Day 10
Others Secondary Endpoints: D5
Exploratory Endpoint: Day 0 to Day 7

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

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)

Yes

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

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

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

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

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:

288

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

398

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

686

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

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

2021-06-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-01-07

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