Clinical Trials Register

Summary
EudraCT Number:	2020-001891-14
Sponsor's Protocol Code Number:	Heparin-SARS-CoV2
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-05-05
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

Spain - AEMPS

A.2

EudraCT number

2020-001891-14

A.3

Full title of the trial

Impact of the use of low molecular weight heparins (LMWH), at prophylactic versus intermediate doses, on SARS-CoV2 infection (COVID-19)

Impacto del uso de heparinas de bajo peso molecular (HBPM), a dosis profiláctica versus intermedia, en la infección por SARS-CoV2 (COVID-19)

A.3.1

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

Impact of the use of low molecular weight heparins (LMWH), at prophylactic versus intermediate doses, on SARS-CoV2 infection (COVID-19)

Impacto del uso de heparinas de bajo peso molecular (HBPM), a dosis profiláctica versus intermedia, en la infección por SARS-CoV2 (COVID-19)

A.3.2

Name or abbreviated title of the trial where available

Heparin-SARS-CoV2

A.4.1

Sponsor's protocol code number

Heparin-SARS-CoV2

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	Fundación Neumosur
B.1.3.4	Country	Spain
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	Fundación Neumosur
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Delos Clinical
B.5.2	Functional name of contact point	Alejandro
B.5.3	Address:
B.5.3.1	Street Address	Calle Editor José Manuel Lara, 28, 1B
B.5.3.2	Town/ city	Sevilla
B.5.3.3	Post code	41013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34630157890
B.5.5	Fax number	+34954308312
B.5.6	E-mail	secretaria@delosclinical.com

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.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ENOXAPARIN SODIUM
D.3.9.1	CAS number	9041-08-1
D.3.9.4	EV Substance Code	SUB11933MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg milligram(s)/kilogram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	Yes
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

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

SARS-CoV-2 coronavirus infection

Infección por coronavirus SARS-CoV-2

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

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

To assess the impact of treatment with LMWH, using prophylactic versus intermediate doses, in terms of escalation in oxygen therapy or the need for invasive mechanical ventilation or mortality in patients admitted with SARS-CoV2 infection

Valorar el impacto del tratamiento con HBPM, utilizando dosis profiláctica versus intermedia, en términos de escalada en la oxigenoterapia o necesidad de ventilación mecánica invasiva o mortalidad en pacientes ingresados con infección por SARS-CoV2

E.2.2

Secondary objectives of the trial

Know the safety of LMWH guideline used in terms of bleeding events, days in hospital and to establish the most favorable patient profile for LMWH treatment.

Conocer la seguridad de las pautas de HBPM utilizadas en términos de eventos hemorrágicos, días de estancia en el hospital y establecer el perfil de pacientes más favorable al tratamiento con HBPM.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients over 18 years old
2. Signature of informed consent
3. Diagnosis by positive PCR for SARS-CoV2 infection
4. They require hospital admission due to fever and other of the established CoV2 admission criteria.
5. Patients with a weight greater than or equal to 60 Kg.

1. Pacientes mayores de 18 años
2. Firma del consentimiento informado
3. Diagnostico mediante PCR positiva por infección de SARS-CoV2
4. Requieran ingreso hospitalario por fiebre persistu otros de los criterios de ingreso establecidos CoV2.
5. Pacientes con peso superior o igual a 60 Kg.

E.4

Principal exclusion criteria

1. Allergy to LMWH.
2. Contraindication for anticoagulation (platelets <25 x 10E9 / L or severe active bleeding, major or clinically relevant bleeding)
3. Pregnancy.
4. Patients with extreme weights. BMI greater than 40.
5. Need for chronic anticoagulant treatment.
6. Need for treatment with high-flow oxygen therapy or mechanical ventilation at the time of study recruitment (within the first 24 hours after admission).
7. Participation in another disease treatment trial
venous thromboembolic.

1. Alergia a HBPM.
2. Contraindicación para la anticoagulación (plaquetas < 25 x 10E9/L o sangrado activo grave, hemorragia mayor o clínicamente relevante)
3. Embarazo.
4. Pacientes con pesos extremos. IMC mayor a 40.
5. Necesidad de tratamiento anticoagulante crónico.
6. Necesidad de tratamiento con oxigenoterapia a alto flujo o ventilación mecánica en el momento del reclutamiento en el estudio (dentro de las primeras 24h tras el ingreso).
7. Participación de otro ensayo de tratamiento de la enfermedad
tromboembólica venosa.

E.5 End points

E.5.1

Primary end point(s)

Need for oxygen therapy escalation due to oxygen saturation (Sat O2) ≤92% with inspired fraction of oxygen (FiO2) ≥0.5 and respiratory rate (FR) ≥30 (IROX index = SatO2 / FiO2] / FR <5.5) or invasive mechanical ventilation or mortality during admission.

Necesidad de escalada de oxigenoterapia por saturación de oxígeno (Sat O2) ≤92% con fracción inspirada de oxígeno (FiO2) ≥0,5 y frecuencia respiratoria (FR) ≥30 (Indice IROX=SatO2/FiO2]/FR < 5.5) o ventilación mecánica invasiva o mortalidad durante el ingreso.

E.5.1.1

Timepoint(s) of evaluation of this end point

30 días

E.5.2

Secondary end point(s)

Need for rescue medication (eg, parenteral corticosteroids, tocilizumab) and days of hospital stay in surviving patients.

Necesidad de medicación de rescate (ej: corticoides parenterales, tocilizumab) y días de estancia en el hospital en los pacientes que sobreviven.

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days

30 días

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

E.6.5

Efficacy

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Otra pauta

Another regimen

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

Last visit of the last subject (LVLS)

Última visita del último paciente incluido

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

F.3.3.1

Women of childbearing potential not using contraception

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

140

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)

The responsible physician will assess the risk / benefit individually to extend or not the prophylaxis
with enoxaparin 40 mg / sc / day.

El médico responsable valorará riesgo/beneficio individualizadamente para extender o no la profilaxis
con enoxaparina 40 mg/sc/día.

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

2020-05-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-29

P. End of Trial
P.	End of Trial Status	Ongoing

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