Clinical Trials Register

Summary
EudraCT Number:	2020-004323-16
Sponsor's Protocol Code Number:	RCT-MP-COVID-19
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-11-23
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-004323-16

A.3

Full title of the trial

A randomized, multicentre, double-blind study to evaluate the efficacy of high-dose administartion of methylprednisolone in addition to standard treatment, in SARS-CoV2 (COVID-19) pneumonia patients.

Uno studio randomizzato, multicentrico, in doppio cieco, per valutare l’efficacia della somministrazione di Metilprednisolone ad alte dosi in aggiunta al trattamento standard, in pazienti affetti da polmonite da SARS-CoV2 (COVID-19).

A.3.1

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

Evaluation of the efficacy of high doses of methylprednisolone in SARS-CoV2 pneumonia patients.

Valutazione dell'efficacia di trattamento ad alte dosi di metilprednisolone in pazienti affetti da polmonite da SARS-CoV2

A.3.2

Name or abbreviated title of the trial where available

RCT-MP-COVID-19

Metilprednisolone ad alte dosi in pazienti Covid-19

A.4.1

Sponsor's protocol code number

RCT-MP-COVID-19

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	AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
B.1.3.4	Country	Italy
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Azienda USL-IRCCS di Reggio Emilia
B.5.2	Functional name of contact point	Massimo Costantini
B.5.3	Address:
B.5.3.1	Street Address	Direzione Scientifica Viale Umberto I, 50
B.5.3.2	Town/ city	Reggio Emilia
B.5.3.3	Post code	42123
B.5.3.4	Country	Italy
B.5.4	Telephone number	3355477208
B.5.5	Fax number	0522295622
B.5.6	E-mail	massimo.costantini@ausl.re.it

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.2.5	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	Metilprednisolone
D.3.2	Product code	[Metilprednisolone]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection/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	METILPREDNISOLONE SODIO SUCCINATO
D.3.9.1	CAS number	2921-57-5
D.3.9.2	Current sponsor code	--
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	1000
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

COVID-19

E.1.1.1

Medical condition in easily understood language

COVID-19 pneumonia

polmonite 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	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10053983
E.1.2	Term	Corona virus infection
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

Evualuate the efficacy of the injection of three boluses of Methylprednisolone (1 gr/die for three days), in addition to standard therapy in patients with COVID-19 pneumonia in terms of time to discharge from the hospital

E.2.2

Secondary objectives of the trial

Evaluation of the effectiveness of three boluses of methylprednisolone (1 g / day for three days), in addition to standard therapy in patients with COVID-19 pneumonia in terms of:
a. prevention of invasive ventilation with oro-tracheal intubation
b. survival for all causes
Safety assessment throughout the study period

Valutazione dell’efficacia di tre boli di Metilprednisolone (1 gr/die per tre giorni), in aggiunta alla terapia standard in pazienti affetti da polmonite COVID-19 in termini di:
a. prevenzione della ventilazione invasiva con intubazione oro-tracheale
b. sopravvivenza per tutte le cause
Valutazione della safety nell’intero periodo dello studio

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. age = 18 years;
2. Informed consent for participation in the study and for data processing;
3. Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection;
4. Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine);
5. Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation;
6. PaO2 / FiO2 between 100 and 300 mmHg.
7. Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days;
8. Serum CRP greater than 5 mg / dL;
9. Interval from onset of SARS-CoV2 infection symptoms to randomization> 5 days

1. età = 18 anni;
2. Consenso informato per la partecipazione allo studio e per il trattamento dei dati;
3. Diagnosi molecolare con test Polymerase Chain Reaction (PCR) dell'infezione da Sars-CoV2;
4. Ricovero in ospedale in un reparto specialistico per la cura dei pazienti Covid-19 (ad es. Malattie infettive, Pneumologia o Medicina Interna);
5. Necessità di ossigeno supplementare in qualsiasi modalità di erogazione con esclusione della ventilazione meccanica invasiva.
6. PaO2/FiO2 compresa fra 100 e 300 mmHg.
7. Diagnosi clinica/strumentale (TAC torace ad alta risoluzione oppure Rx torace oppure ecografia polmonare) di polmonite interstiziale da non più di tre giorni;
8. PCR sierica maggiore di 5 mg/dl
9. Intervallo fra comparsa dei sintomi di infezione da SARS-CoV2 e randomizzazione > 5 giorni

E.4

Principal exclusion criteria

1. Invasive mechanical ventilation;
2. Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit;
3. Pregnancy or breastfeeding;
4. Severe heart or kidney failure;
5. Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception;
6. Diabetes not compensated according to the doctor's judgment;
7. Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment;
8. Steroid bolus therapy in the week prior to enrollment for the study;
9. Enrollment in another clinical trial;
10. Patient already randomized in this study

1. Ventilazione meccanica invasiva
2. Presenza di shock o di concomitante insufficienza d’organo che richiede ammissione all’Unità di Cura Intensiva;
3. Gravidanza o allattamento;
4. Insufficienza cardiaca o renale grave;
5. Ipersensibilità nota al metilprednisolone, al desametasone o ad un eccepiente;
6. Diabete non compensato secondo il giudizio del medico
7. Altre condizioni cliniche che controindicano il Metilprednisolone e non possono essere trattate o risolte secondo il giudizio del medico;
8. Terapia con boli steroidei nella settimana precedente l’arruolamento per lo studio
9. Arruolamento in altra sperimentazione clinica
10. Paziente già randomizzato in questo studio

E.5 End points

E.5.1

Primary end point(s)

Lenght of hospitalization, calculated as the interval between randomization and discharge from the hospital without the need for supplemental oxygen

Durata del ricovero in ospedale, calcolata come intervallo tra la randomizzazione e la dimissione dall’ospedale senza necessità di ossigeno supplementare

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days since randomisation

30 giorni dalla randomizzazione

E.5.2

Secondary end point(s)

Invasive ventilation-free survival with orotracheal intubation; Overall survival, defined as the time between randomisation and death for any cause

Sopravvivenza libera da ventilazione invasiva con intubazione orotracheale; Sopravvivenza complessiva, definita come intervallo tra la randomizzazione e l’eventuale decesso per qualsiasi causa

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days since randomisation; 30 days since randomisation

30 giorni dalla randomizzazione; 30 giorni dalla randomizzazione

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

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

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

Information not present in EudraCT

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

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

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:

130

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-11-23.

Yes

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

Yes

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

260

F.4.2

For a multinational trial

F.4.2.1

In the EEA

260

F.4.2.2

In the whole clinical trial

260

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)

Follow Up with standard care

Follow up attivo con trattamento standard

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

2020-11-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-25

P. End of Trial
P.	End of Trial Status	Completed

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