Clinical Trials Register

Summary
EudraCT Number:	2020-002009-25
Sponsor's Protocol Code Number:	SARSCov2EFTI1.0
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-06-04
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

Czechia - SUKL

A.2

EudraCT number

2020-002009-25

A.3

Full title of the trial

The efficacy and safety of Eftilagimod Alpha Treatment by immune
modulation in COVID-19 disease (EAT COVID trial)

Účinnost a bezpečnost léčby Eftilagimodem alfa imunitní modulací u
onemocnění COVID-19 (studie EAT COVID)

A.3.1

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

The efficacy and safety of Eftilagimod Alpha Treatment in COVID-19
disease (EAT COVID trial)

Účinnost a bezpečnost léčby Eftilagimodem alfa u onemocnění COVID-19
(studie EAT COVID)

A.3.2

Name or abbreviated title of the trial where available

EAT COVID trial

studie EAT COVID

A.4.1

Sponsor's protocol code number

SARSCov2EFTI1.0

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	Fakultní nemocnice Plzeň
B.1.3.4	Country	Czechia
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	Lékařská fakulta UK Plzeň
B.4.2	Country	Czechia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fakultní nemocnice
B.5.2	Functional name of contact point	prof. MUDr. Martin Matějovič, Ph.D.
B.5.3	Address:
B.5.3.1	Street Address	Alej Svobody 80
B.5.3.2	Town/ city	Plzeň
B.5.3.3	Post code	30460
B.5.3.4	Country	Czechia
B.5.4	Telephone number	+420377103111
B.5.6	E-mail	matejovic@fnplzen.cz

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.2.5	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	Eftilagimod Alpha
D.3.2	Product code	IMP321
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
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	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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous 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 disease

nemoc COVID-19

E.1.1.1

Medical condition in easily understood language

COVID-19 disease

nemoc 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

We aim to assess the effects of Eftilagimod alpha (Efti) on the number of
days alive without life-support in adult patients hospitalised with COVID-
19. Eftilagimod Alpha leads to enhanced presentation of viral antigens to
T-cells resulting in an effective, sustained antiviral response and viral
clearance.

Snažíme se posoudit účinky Eftilagimod alpha (Efti) na počet dnů života
bez podpory orgánů u dospělých pacientů hospitalizovaných s COVID-19.
Eftilagimod Alpha vede k lepší prezentaci virových antigenů T-buňkám,
což vede k účinné a trvalé antivirové odpovědi a ke clearance viru.

E.2.2

Secondary objectives of the trial

To evaluate the effects of Efti on indicators of inflammation, need for
oxygen therapy, mechanical ventilation, length of hospitalisation and
mortality.

Vyhodnocení účinků Efti na ukazatele zánětu, potřeby kyslíkové terapie,
mechanické ventilace, délky hospitalizace a úmrtnosti.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Adults (>18yrs of age) with confirmed COVID-19 disease who require
hospital admission
2. Need for less than 8L/min of O2 via supplemental device to maintain
SpO2 > 92%
3. Signed informed consent by patient

1. Dospělí (18 let a více) s potvrzenou nemocí COVID-19, kteří vyžadují hospitalizaci
2. Potřebují méně než 8L/min O2 prostřednictvím jakéhokoliv zařízení k
udržení FiO2 > 92%
3. Podepsaný informovaný souhlas pacienta

E.4

Principal exclusion criteria

1. Patients who require > 8L O2/min via a supplemental device to
maintain SpO2>92%
2. Patients who are in shock as defined by vasopressor requirements
3. Patients with clear limitations of treatment (not for intubation)
4. Moribund patients
5. Pregnant patients
6. Known allergy to Eftilagimod Alpha, or L-Arginine

1. Pacienti, kteří potřebují > 8L O2/min prostřednictvím doplňkového
zařízení k udržení SpO2>92%
2. Pacienti, kteří jsou v šoku - definováno požadavky na vasopresor
3. Pacienti s jasnými omezeními léčby (ne pro intubaci)
4. Umírající pacienti
5. Těhotné pacientky
6. Známá alergie na Eftilagimod Alpha, nebo L-arginin

E.5 End points

E.5.1

Primary end point(s)

patient's clinical status (on a 7-point ordinal scale) at day 15 as per an
adapted WHO recommended study protocol.
1. Not hospitalized,
2. Hospitalized, not requiring supplemental oxygen
3. Hospitalized, requiring supplemental oxygen
4. Hospitalized, on high flow oxygen device
5. Hospitalized in ICU, on non-invasive ventilation
6. Hospitalized in ICU, on invasive mechanical ventilation or ECMO
7. Death

klinický stav pacienta (v 7-bodové řadové stupnici) v den 15 podle
upraveného protokolu doporučeného WHO.
1. Nehospitalizován
2. Hospitalizován, nevyžaduje doplňkový kyslík
3. Hospitalizován, vyžadující doplňkový kyslík
4. Hospitalizován, na vysokoprůtokovém kyslíkovém zařízení
5. Hospitalizován na JIP, na neinvazivní ventilaci
6. Hospitalizován na JIP, na invazivní mechanické ventilaci nebo ECMO
7. Smrt

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 15 post study entry

Den 15 od zařazení do studie

E.5.2

Secondary end point(s)

1. Supplemental oxygen free days in the first 28 days (up to day 29)
2. Ventilator free days in the first 28 days (up to day 29)
3. Subject clinical status (on a 7-point ordinal scale as above) at day 7
and day 21, respectively
4. ICU LOS
5. Hospital LOS
6. Mortality at 28 and 90 days

1. Dny bez přídatného kyslíku v prvních 28 dnech (až do dne 29)
2. Dny bez ventilátoru v prvních 28 dnech (do dne 29)
3. Klinický stav subjektu (na stupnici 7 bodů, jak je uvedeno výše) v den
7 a v den 21
4. Délka hospitalizace na JIP
5. Délka hospitalizace v nemocnici
6. Smrtnost ve dnech 28 a 90 dnů

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 7, 21, 28, and 90 post study entry

7, 21, 28 a 90 dnů po vstupu do studie

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

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)

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.8.3

The trial involves single site in the Member State concerned

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:

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

Yes

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

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)

None

žádný

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

2020-10-01

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-09-01

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