Clinical Trials Register

Summary
EudraCT Number:	2020-001623-13
Sponsor's Protocol Code Number:	T3inj-02/Thy-Support
National Competent Authority:	Greece - EOF
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-04-22
Trial results	View 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

Greece - EOF

A.2

EudraCT number

2020-001623-13

A.3

Full title of the trial

Triiodothyronine for the treatment of critically ill patients with COVID-19 infection (Thy-Support Study)

Η τριϊωδοθυρονίνη για την θεραπεία των σοβαρά νοσούντων ασθενών με λοίμωξη από COVID-19 (μελέτη Thy-Support)

A.3.1

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

Triiodothyronine for the treatment of critically ill patients with COVID-19 infection (Thy-Support Study)

Η τριϊωδοθυρονίνη για την θεραπεία των σοβαρά νοσούντων ασθενών με λοίμωξη από COVID-19 (μελέτη Thy-Support)

A.3.2

Name or abbreviated title of the trial where available

Thy-Support STUDY

ΜΕΛΕΤΗ Thy-Support

A.4.1

Sponsor's protocol code number

T3inj-02/Thy-Support

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	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
B.1.3.4	Country	Greece
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
B.4.2	Country	Greece
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
B.5.2	Functional name of contact point	Ioulia Tseti
B.5.3	Address:
B.5.3.1	Street Address	14th km National Road 1
B.5.3.2	Town/ city	Κifissia
B.5.3.3	Post code	145 64
B.5.3.4	Country	Greece
B.5.4	Telephone number	00302108072512
B.5.5	Fax number	00302108078907
B.5.6	E-mail	unipharma@uni-pharma.gr

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	T3® Solution for injection 10 μg/ml
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LIOTHYRONINE SODIUM
D.3.9.1	CAS number	55-06-1
D.3.9.4	EV Substance Code	SUB02931MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

ICU patients diagnosed with pulmonary infection due to COVID-19 and require mechanical respiratory support or ECMO

Βαρέως πάσχοντες ασθενείς που νοσηλεύονται σε ΜΕΘ λόγω λοίμωξης από COVID19 και χρειάζονται μηχανική αναπνευστική υποστήριξη

E.1.1.1

Medical condition in easily understood language

ICU patients diagnosed with pulmonary infection due to COVID-19

Βαρέως πάσχοντες ασθενείς που νοσηλεύονται σε ΜΕΘ λόγω λοίμωξης από COVID19

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	PT
E.1.2	Classification code	10051905
E.1.2	Term	Coronavirus infection
E.1.2	System Organ Class	10021881 - Infections and infestations

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 primary objective of the study is to determine whether the administration of intravenous triiodothyronine in ICU patients diagnosed with pulmonary infection due to COVID-19 facilitates weaning from cardiorespiratory support compared to placebo.

Ο πρωταρχικός στόχος της μελέτης είναι να προσδιορίσει εάν η χορήγηση ενδοφλεβίως τριιωδοθυρονίνης σε ασθενείς που θα διαγνωσθούν με αναπνευστική λοίμωξη από COVID-19 σε κρίσιμη κατάσταση διευκολύνει τον απογαλακτισμό από την καρδιοαναπνευστική υποστήριξη σε σχέση με την ομάδα του εικονικού φαρμάκου.

E.2.2

Secondary objectives of the trial

1.Assessment of hemodynamic status
2.Assessment of pulmonary function
3.Assessment of hepatic and renal function
4.Assessment of cardiac function
5.Assessment of the course of COVID-19 infection
6.Assessment of clinical outcome and safety

1.Εκτίμηση της αιμοδυναμικής κατάστασης
2.Εκτίμηση της αναπνευστικής λειτουργίας
3.Εκτίμηση της ηπατικής και νεφρικής λειτουργίας
4.Εκτίμηση της καρδιακής λειτουργίας
5.Εκτίμηση της πορείας της λοίμωξης από COVID-19
6.Εκτίμηση του κλινικού αποτελέσματος και της ασφάλειας

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Patients diagnosed with pulmonary infection due to COVID-19, admitted
in ICU and require mechanical ventilation or ECMO
•Male and female with Age>18 years old
•Signed informed consent from patient or relatives

•Ασθενείς που θα διαγνωσθούν με αναπνευστική λοίμωξη από COVID-19, θα εισαχθούν σε ΜΕΘ και χρειάζονται αναπνευστήρα ή ECMO
•Άντρες και γυναίκες ηλικίας >18 ετών
•Υπογραφή εντύπου συγκατάθεσης

E.4

Principal exclusion criteria

•Pregnant or breast-feeding women
•Severe systemic disease (e.g. cancer) before infection accompanied by reduced life expectancy <6 months
•Participation in another trial of an investigational drug or device

•Κύηση ή θηλασμός
•Σοβαρή συστηματική νόσος (π.χ.καρκίνος) πριν από τη λοίμωξη που συνοδεύεται από μειωμένο προσδόκιμο επιβίωσης <6 μήνες
•Συμμετοχή σε άλλη κλινική μελέτη ελέγχου φαρμάκου ή συσκευής

E.5 End points

E.5.1

Primary end point(s)

The primary end-point assessed in the present study will be the percentage of patients successfully weaned after 30 days of follow-up. Successful weaning is expected in 15% of patients in placebo group. We assume that T3 treatment can increase successful weaning to 50% of patients which is a significant clinical improvement in prognosis.

Το κύριο καταληκτικό σημείο της αποτελεσματικότητας θα είναι το ποσοστό των ασθενών που βγήκαν από τη τεχνητή αναπνευστική υποστήριξη σε σύγκριση με την ομάδα placebo.
Επιτυχής απογαλακτισμός από την τεχνητή αναπνευστική υποστήριξη αναμένεται σε 15% των ασθενών στην ομάδα του εικονικού φαρμάκου (placebo group). Αναμένουμε οτι η θεραπεία με Τ3 μπορεί να αυξήσει τον επιτυχή απογαλακτισμό σε 50% που αποτελεί μια πολύ σημαντική βελτίωση της πρόγνωσης.

E.5.1.1

Timepoint(s) of evaluation of this end point

Treatment period will last till successful weaning or end of follow-up. Follow up will be performed for 1 month.

H περίοδος χορήγησης του φαρμάκου θα διαρκέσει μέχρι τον επιτυχή απογαλακτισμό ή μέχρι το τέλος της παρακολούθησης. Η περίοδος παρακολούθησης θα διαρκέσει 1 μήνα.

E.5.2

Secondary end point(s)

Δεν εφαρμόζεται

E.5.2.1

Timepoint(s) of evaluation of this end point

Δεν εφαρμόζεται

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.8.2.4

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

Τελευταία Επίσκεψη Τελευταίου Ασθενούς

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	20
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	40
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	Yes
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	60
F.4.2	For a multinational trial
F.4.2.2	In the whole clinical trial	60

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

2020-05-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-20

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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