Clinical Trials Register

Summary
EudraCT Number:	2020-003475-18
Sponsor's Protocol Code Number:	COV-AAT
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-09-16
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2020-003475-18

A.3

Full title of the trial

The potential of oral Camostat in early COVID-19 disease in an ambulatory setting to reduce viral load and disease burden.

Het vermogen van Camostat om de virale lading en het ziekteverloop te beïnvloeden wanneer het wordt toegediend in vroege COVID-19 infectie in een ambulante setting.

A.3.1

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

Study on the antiviral effects of Camostat in COVID-19.

Studie naar de antivirale effecten van Camostat in COVID-19.

A.3.2

Name or abbreviated title of the trial where available

COV-AAT

A.4.1

Sponsor's protocol code number

COV-AAT

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	Ghent University Hospital
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	Ono Pharmaceutical Co., Ltd.
B.4.2	Country	Japan
B.4.1	Name of organisation providing support	Byteflies
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	Ghent University Hospital
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	Ghent University Hospital
B.5.2	Functional name of contact point	HIRUZ
B.5.3	Address:
B.5.3.1	Street Address	C. Heymanslaan 10
B.5.3.2	Town/ city	Ghent
B.5.3.3	Post code	9000
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+3293320500
B.5.5	Fax number	+3293320520
B.5.6	E-mail	hiruz.ctu@uzgent.be

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	Foipan
D.2.1.1.2	Name of the Marketing Authorisation holder	Ono Pharmaceutical Co., Ltd.
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.3.1	Product name	Camostat mesilate
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	CAMOSTAT MESILATE
D.3.9.1	CAS number	59721-29-8
D.3.9.4	EV Substance Code	SUB01007MIG
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	100
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	Tablet
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

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

E.1.1.1

Medical condition in easily understood language

coronavirus disease 2019 (COVID-19)

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

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 aim of the study is to assess whether Camostat, a serine protease inhibitor available in an oral formulation, has the potential to be studied as an antiviral drug in a large scale ambulatory setting to prevent transmission by decreasing viral load, to prevent symptoms after exposure (PEP) in asymptomatic individuals or to prevent disease progression in the occurrence of early symptomatology. In this pilot we will assess efficacy of the drug in terms of viral load changes at D5 compared to baseline in nasopharyngeal (or nose/throat) swabs. Cycle threshold values will be used as a surrogate for viral load.

Descriptive objectives are to assess the safety and compliance of the drug in ambulatory setting.

E.2.2

Secondary objectives of the trial

- To estimate the clinical outcome of patients based on daily clinical scales;
- To estimate the effectiveness of the drug to prevent hospitalization, intensive care hospitalization, oxygenation and death at D14 and D28.

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

Substudies:
- PK/PD substudy: pharmacokinetics and pharmacodynamics study on blood;
- Odor substudy: odor samples study;
- COVIM2.0 substudy: blood and nasopharyngeal swabs study;
- Screening failures substudy: blood and nasopharyngeal swabs study.

Objectives substudies:
- PK/PD substudy: quantify PK/PD parameters of camostat metabolite and interpatient variability in COVID-19 infected patients;
- Odor substudy: to estimate whether dogs can be trained to successfully detect COVID-19 positive individuals based on odor;
- COVIM2.0 substudy: understanding of the pathophysiological mechanisms behind SARS-CoV2;
- Screening failures substudy: to estimate whether asymptomatic COVID-19 positive individuals with high CT values, not eligible for the drug administration, can transmit the virus and therefore should be isolated and whether they develop antibodies despite their mild infection.

E.3

Principal inclusion criteria

- Aged ≥18
- Willing to participate and fill out a daily symptom diary
- Willing to take the parameters such as blood oxygenation and temperature
- Willing to attend follow-up visits both by phone as at the clinic
- Capable of understanding the commitment in the trial
- Signed informed consent
- Signs and symptoms suggestive of COVID disease in absence of hospitalization criteria as defined by the flowchart used at the emergency department at Ghent University Hospital, present for maximum 5 days and confirmed by PCR
• OR documented COVID-19 infection by PCR with CT value below the threshold of 30 in asymptomatic individuals
- For women of childbearing potential: they should be willing to use highly effective method of contraception during treatment and until the end of study defined as having a failure rate of less than 1% per year when used consistently and correctly
- For men of reproductive potential: condom should be used as contraception during treatment and until the end of study when having a partner of childbearing potential

E.4

Principal exclusion criteria

- Inability to make a decision to participate
- Pregnant or breast feeding
- Inability to take oral medication
- Inability to provide informed written consent
- Known hypersensitivity towards Camostat or other Serine protease inhibitors
- Any condition that, in the Investigator’s opinion, prevents adequate compliance with study therapy.
- Any COVID infection at risk for hospitalisation as described in the flow chart used at the emergency department
- With regard to exclusion of women of child-bearing potential, women who tell us they know they are pregnant are excluded. All women of child-bearing potential who test positive for pregnancy by urine test or serum (if an early pregnancy cannot be excluded) at first visit are excluded
- Severe chronic pancreatitis requiring suction of gastric juice, fasting or abstention from drinking
- Postoperative reflux oesophagitis due to reflux or gastric juice
- Postoperative reflux oesophagitis (if improvement of symptoms is not observed)

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) log10 viral load.

Descriptive endpoints are to assess the safety and compliance of the drug in ambulatory setting.

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

- Days to clinical improvement from study enrolment, defined as no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache) using a standardised symptom assessment scale modified from the FLU-PRO tool by DR. Vinetz, Yale University. Symptoms will be assessed daily from D1-D14 and up to D28 if patients are still symptomatic at D14 and compared to baseline using questionnaires and monitoring of temperature 4x daily, oxygen saturation, respiratory rate and heart rate
- Clinical status as assessed by the 7-point ordinal scale at day 0, 3, 5, 10 and 28 (Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on noninvasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death)
- The effectiveness of the selected drug to prevent death at D14 and D28
- The effectiveness of the selected drug to prevent hospitalization and oxygenation at D14 and D28
- The effectiveness of the selected drug to prevent intensive care hospitalization at D14 and D28
- If available, the effect of the selected drug on pulmonary infiltrates by RX or HRCT will be assessed at D5 or D10 compared to baseline. The CO-RADS classification will be used to assess the findings
- If available, the effect of the selected drug on inflammatory parameters at D5 and D10 compared to baseline
- The efficacy of the drug in terms of change from day 0 to day 10 in respiratory (oropharyngeal swab RT-PCR) log10 viral load in patients with positive PCR at D5
- The efficacy of the drug in terms of change from day 0 to day 28 in respiratory (oropharyngeal swab RT-PCR) log10 viral load in patients with positive PCR at D10
- The probability of finding viable virus after virus culture from swabs in COVID 19 infected individuals at D0 (and at D5, D10 and D28 if PCR remains positive)
- The emergence of resistance for each of the selected drug regimens in case of prolonged viral shedding at D10 and D28 in individuals with positive PCR at these timepoints
- The presence of neutralising antibodies at D28
- Number of participant-reported secondary infection of housemates (and/or close contacts) at D28

E.5.2.1

Timepoint(s) of evaluation of this end point

see secondary end points

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

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:

130

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

150

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

2020-09-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-10-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-06-24

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