Clinical Trials Register

Summary
EudraCT Number:	2020-001052-18
Sponsor's Protocol Code Number:	010
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-04-07
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

Spain - AEMPS

A.2

EudraCT number

2020-001052-18

A.3

Full title of the trial

A Multicenter, Adaptive, Randomised Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults - Version for European Union/United Kingdom Sites

Ensayo clínico controlado multicéntrico, adaptativo, ciego, aleatorizado, de seguridad y eficacia de la terapia en investigación para el tratamiento de COVID-19 en adultos hospitalizados - Versión para centros de la Unión Europea / Reino Unido

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

Adaptive COVID-19 Treatment Trial in the EU & UK (ACTT-EU/UK)

Ensayo de tratamiento adaptativo con COVID-19 en la UE y el Reino Unido (ACTT-EU / UK)

A.4.1

Sponsor's protocol code number

010

A.5.4

Other Identifiers

Name:

DMID - NIH

Number:

20-0006, Version no. 2.0

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	Regents of the University of Minnesota
B.1.3.4	Country	United States
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	National Institute of Health
B.4.2	Country	United States
B.4.1	Name of organisation providing support	University of Minnesota
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	HOSPITAL GERMANS TRIAS I PUJOL
B.5.2	Functional name of contact point	Roger Paredes
B.5.3	Address:
B.5.3.1	Street Address	Carretera de Canyet, s/n
B.5.3.2	Town/ city	Badalona
B.5.3.3	Post code	08916
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3493465 6374
B.5.5	Fax number	+3493465 3968
B.5.6	E-mail	rparedes@irsicaixa.es

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	REMDESEVIR
D.3.2	Product code	GS-5734
D.3.4	Pharmaceutical form	Lyophilisate for solution for infusion
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	REMDESIVIR
D.3.9.2	Current sponsor code	GS-5734
D.3.9.4	EV Substance Code	SUB195655
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	100 to 200
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 infusion
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

Influenza COVID-19

E.1.1.1

Medical condition in easily understood language

Influenza 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	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10022005
E.1.2	Term	Influenza viral infections
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

The overall objective of the study is to evaluate the clinical efficaty of different investigational therapeutics relative to the control arm in adults hospitalised with COVID-19.
The primary objective will be determined by a pilot study of the first 100 subjects
Subject clinical status (8-point ordinal scale) at day 15 is the default primary endpoint

El objetivo general del estudio es evaluar la eficacia clínica de diferentes terapias de investigación en relación con el brazo de control en adultos hospitalizados con COVID-19.
El objetivo principal será determinado por un estudio piloto de los primeros 100 sujetos.
El estado clínico del sujeto (escala ordinal de 8 puntos) en el día 15 es el punto final primario predeterminado

E.2.2

Secondary objectives of the trial

1. Evaluate the clinical efficaty of different investigational therapeutics as compared to the control arm as assessed by:
Clinical Severity: Ordinal scale, National Early Warning Scores, Oxygenation; Non-invasive ventilation/high flow oxygen, Invasive Mechanical ventilation/extracoporeal membrane oxygenation (ECMO)
Hospitalisation: Duration of hospitalisation
Mortality: 14-day mortality, 28-day mortality

2. Evaluate the safety of different investigational therapeutics as compared to the control arm as assessed by:
Commulative incidence of SAE thorough Day 29
Commulative incidence of Grade 3 and 4 clincial and/or laboratory AEs through Day 29
Discontinuation or temporary suspensiion of infusions (for any reason)
Changes in WBC with differential, hemoglobin, platelets, creatinine, total bilirubin, ALT, AST, and PT over time (analysis of lab. values in addition to AEs noted above

Exploratory with stored samples (separate consent required) Evaluation of Virology efficacy

1. Evaluar la eficacia clínica de diferentes terapias de investigación en comparación con el brazo de control según:
Severidad clínica: escala ordinal, puntajes nacionales de alerta temprana, oxigenación; Ventilación no invasiva / oxígeno de alto flujo, ventilación mecánica invasiva / oxigenación por membrana extracorporal
Hospitalización: duración de la hospitalización
Mortalidad: mortalidad a los 14 días, mortalidad a los 28 días

2. Evaluar la seguridad de las terapias de investigación en comparación con el brazo de control según:
Incidencia acumulativa de SAE hasta día 29
Incidencia acumulativa de AA de grado 3 y 4 en clínica y/o laboratorio hasta día 29
Interrupción o suspensión temporal de infusión (por cualquier motivo)
Cambios en el recuento de glóbulos blancos diferencial, hemoglobina, plaquetas, creatinina, bilirrubina total, ALT, AST y Tiempo de protrombina a lo largo del tiempo

3.Exploratorio con muestras almacenadas : Evaluación de la eficacia virológica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Admitted to a hospital with synmptoms suggestive of COVID-19 infection
2. Subject (or legally authorised representative) provides written informed consent prior to initiation of any study procedures
3. Subject (or legally authorised representative) understands and agrees to comply wiht planned study procedures
4.Male or non-pregnant female adult ≥ 18 years of age at time of enrollment
5. Has laboratory - confirmed SARS-CoV-2 infection as determined by PCR or othe rcommercial or public health assay in any specimen collected < 72 hous prior to randomisation
6. Illness of any duaration, and at least one of the following:
Radiographic infiltrates by imagin, OR Clincial assessment (evidence of rales/crackels on exam) AND SpO2 ≤ 94% on room air, OR Requiring supplemental oxygen, OR Requiring mechanical ventilation
7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not incluidng hormonal contraception from the time of screening through Day 29
8. Agrees to not participate in antoehr clinical trial for treatment of COVID-19 or SARS-CoV-2

1. Ingresado en un hospital con síntomas sugestivos de infección por COVID-19
2. Sujeto (o representante legalmente) que proporciona su consentimiento informado por escrito antes de iniciar cualquier procedimiento de estudio.
3. Sujeto (o representante legalmente) que entiende y acepta cumplir con los procedimientos de estudio
4.Hombres o mujeres no embarazadas ≥ 18 años de edad en el momento de inclusión
5. Infección por SARS-CoV-2 confirmada por laboratorio por PCR u otro ensayo de salud comercial o pública en cualquier muestra recolectada <72 horas antes de la aleatorización.
6. Enfermedad de cualquier duración, y al menos uno de los siguientes:
• Infiltrados radiográficos por imagen, o evaluación clínica (evidencia de crepitaciones) y SpO2 ≤ 94% en aire ambiente, o requerir oxígeno suplementario, o requiere ventilación mecánica.
7. Mujeres en edad fértil deben aceptar la abstinencia o utilizar al menos un método anticonceptivo primario que no incluya la anticoncepción hormonal desde el momento del examen hasta el día 29
8. Acuerda no participar en otro ensayo clínico para el tratamiento de COVID-19 o SARS-CoV-2. hasta el día 29.

E.4

Principal exclusion criteria

1. ALT/AST > 5 times the upper limit of normal
2. Estimated glumerular filtration rate (eGFR) < 50 or requiring dialysis
3. Pregnancy or breast feeding
4. Anticipated transfer to another hospital which is not a study site within 72 hours
5. Allergy to any study medication

1. ALT / AST> 5 veces el límite superior de lo normal
2. Tasa estimada de filtración glumerular (eTFG) <50 o que requiere diálisis
3. Embarazo o lactancia.
4. Transferencia anticipada a otro hospital que no es un sitio de estudio dentro de las 72 horas
5. Alergia a cualquier medicamento del estudio.

E.5 End points

E.5.1

Primary end point(s)

Death
Hospitalised on invasive mechanical ventilation or ECMO
Hospitalised on non-invasive ventilation or high flow oxygen devices
Hospitalised, requiring supplemental oxygen
Hospitallised, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
Hospitalised, not requiring supplemental oxygen - no longer requires ongoing medical care
Not hospitalised, limitation on activities and/or requiring home oxygen
Not hospitalised, no limitations on activities

Muerte
Hospitalizado con ventilación mecánica invasiva o ECMO
Hospitalizado con ventilación no invasiva o dispositivos de oxígeno de alto flujo
Hospitalizado, que requiere oxígeno suplementario
Hospitalizado, no requiere oxígeno suplementario, requiere atención médica continua (relacionada con COVID-19 o de otra manera)
Hospitalizado, que no requiere oxígeno suplementario: ya no requiere atención médica continua
No hospitalizado, limitación de actividades y / o que requiere oxígeno en el hogar
No hospitalizado, sin limitaciones en las actividades.

E.5.1.1

Timepoint(s) of evaluation of this end point

Subjects will be assessed daily while hospitalised.
Subjects discharged from the hospital will be asked to attend study visits at Days 15 and 29.
The day 22 vist may be conducted by phone
All subcject with undrgo a series of efficacy, safety and laboratory assessments.
Blood samples and OP swabs will be obtained on Day 1 (prior to infusion), 3, 5, 8, 11 (while hospitalised) and Day 15 and 29

Los sujetos serán evaluados diariamente mientras estén hospitalizados.
Los sujetos dados de alta del hospital deberán asistir a las visitas de estudio en los días 15 y 29.
El día 22 la visita puede realizarse por teléfono.
Todos los sujetos están sujetos a una serie de evaluaciones de eficacia, seguridad y laboratorio.
Las muestras de sangre y los hisopos OP se obtendrán el día 1 (antes de la infusión), 3, 5, 8, 11 (mientras esté hospitalizado) y los días 15 y 29

E.5.2

Secondary end point(s)

Clinical outcome assessed using ordinal scale daily while hospitalised and on Day 15, 22 and 29
NEWS assessed daily while hospitalised and on Day 15 and 29
Days of supplemental oxygen (if applicable)
Days of non-invasive ventilation (if applicable)
Days of high flow oxygen (if applicable)
Days of invasive mechanical ventilation (if applicable)
Days of ECMO (if applicable)
Days of hospitalisation
Date and cause of death (if applicable)
SAEs
Grade 3 and 4 AEs
WBC, with differential, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, AST, and PT on Day 1, days 3, 5, 8 and 11 (while hospitalized) and Day 15 and 29 (if attends in-person visit or still hospitalized).

Resultado clínico evaluado utilizando escala ordinal diariamente mientras está hospitalizado y en los días 15, 22 y 29
Escala NEWS evaluada diariamente mientras esta hospitalizado y en los días 15 y 29
Días de oxígeno suplementario (si corresponde)
Días de ventilación no invasiva (si corresponde)
Días de alto flujo de oxígeno (si corresponde)
Días de ventilación mecánica invasiva (si corresponde)
Días de ECMO (si corresponde)
Días de hospitalización
Fecha y causa de muerte (si corresponde)
SAE
Grado 3 y 4 AEs
Recuento de glóbulos blancos diferencial, hemoglobina, plaquetas, creatinina, glucosa, bilirrubina total, ALT, AST y PT el día 1, días 3, 5, 8 y 11 (mientras está hospitalizado) y los días 15 y 29 (si asiste a una visita en persona o aún hospitalizado).

E.5.2.1

Timepoint(s) of evaluation of this end point

Los sujetos serán evaluados diariamente mientras estén hospitalizados.
Los sujetos dados de alta del hospital deberán asistir a las visitas de estudio en los días 15 y 29.
El día 22 la visita puede realizarse por teléfono.
Todos los sujetos están sujetos a una serie de evaluaciones de eficacia, seguridad y laboratorio.
Las muestras de sangre y los hisopos orofaringe se obtendrán el día 1 (antes de la infusión), 3, 5, 8, 11 (mientras esté hospitalizado) y los días 15 y 29

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)

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

Yes

E.8.1.7.1

Other trial design description

adaptativo

Adaptive

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Denmark

Germany

Spain

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

Ultima visita ultimo participante

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

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:

340

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

440

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

ninguno

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	INSIGHT (International Network for Strategic Initiatives in Global HIV Trials)
G.4.3.4	Network Country	United States

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-04-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-06

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-09-10

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IMP with orphan designation in the indication
Orphan Designation Number:
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