Clinical Trials Register

Summary
EudraCT Number:	2020-001987-28
Sponsor's Protocol Code Number:	PRECOV
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-06-24
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

2020-001987-28

A.3

Full title of the trial

PRECOV: a randomized controlled clinical trial on the effects of hydroxychloroquine in the prevention of COVID-19 in healthcare workers at risk

PRECOV: studio clinico controllato e randomizzato sugli effetti della idrossiclorochina nella prevenzione di COVID-19 in operatori sanitari a rischio

A.3.1

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

PRECOV: a randomized controlled clinical trial on the effects of hydroxychloroquine in the prevention of COVID-19 in healthcare workers at risk

PRECOV: studio clinico controllato e randomizzato sugli effetti della idrossiclorochina nella prevenzione di COVID-19 in operatori sanitari a rischio

A.3.2

Name or abbreviated title of the trial where available

PRECOV

A.4.1

Sponsor's protocol code number

PRECOV

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	OSPEDALE SAN RAFFAELE
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	IRCCS Ospedale San Raffaele
B.5.2	Functional name of contact point	IRCCS Ospedale San Raffaele
B.5.3	Address:
B.5.3.1	Street Address	Via Olgettina 60
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20132
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390226432990
B.5.5	Fax number	+390226433746
B.5.6	E-mail	comi.giancarlo@hsr.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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	IDROSSICLOROCHINA SOLFATO
D.3.2	Product code	[IDROSSICLOROCHINA SOLFATO]
D.3.4	Pharmaceutical form	Coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IDROSSICLOROCHINA SOLFATO
D.3.9.1	CAS number	118-42-3
D.3.9.2	Current sponsor code	IDROSSICLOROCHINA SOLFATO
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	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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Healthcare personnel at risk of SARS-CoV-2 infection

Personale sanitario a rischio d'infezione da SARS-CoV-2

E.1.1.1

Medical condition in easily understood language

Healthcare personnel at risk of SARS-CoV-2 infection

Personale sanitario a rischio d'infezione da SARS-CoV-2

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.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10061986
E.1.2	Term	SARS
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

To evaluate the efficacy of the preventive treatment with hydroxychloroquine in reducing the risk of SARS-CoV-2 infection in healthcare workers at risk

Valutare l’efficacia del trattamento preventivo con idrossiclorochina nel ridurre il rischio di infezione da SARS-CoV-2 in personale sanitario a rischio.

E.2.2

Secondary objectives of the trial

• To evaluate the efficacy of the preventive treatment with hydroxychloroquine in reducing the severity of COVID-19 clinical manifestations
• To evaluate the safety and tolerability of hydroxychloroquine as a prophylaxis treatment for SARS-CoV-2

• Valutare l’efficacia del trattamento preventivo con idrossiclorochina nel ridurre la gravità di manifestazioni cliniche di COVID-19
• Valutare la sicurezza e la tollerabilità del trattamento di profilassi per SARS-CoV-2 con idrossiclorochina

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Informed consent for participation to the study
2. Age between 18 and 70 years
3. RT-PCR negative for SARS-CoV-2
4. Antibody test for negative SARS-CoV-2

1. Consenso informato per la partecipazione allo studio
2. Età compresa tra i 18 ed i 70 anni
3. RT-PCR negativo per SARS-CoV-2
4. Test anticorpale per SARS-CoV-2 negativo

E.4

Principal exclusion criteria

1. Presence of co-morbidity or concomitant intake of drugs that can interfere with the risk of contracting the infection or influence its course: diabetes, heart failure, neoplastic pathologies, etc.)
2. Immunoactive treatments ongoing
3.State of pregnancy or breastfeeding
4. Contraindications to the use of hydroxychloroquine:
History of hypersensitivity or allergy to hydroxychloroquine
b.Deficit of glucose-6 phosphate dehydrogenase
c.Porfiria
d.Psoriasi
e.Weight <40 kg
f) Previously referred to as retinopathy or visual field disturbances or concomitant intake of drugs known to induce retinopathy (e.g. tamoxifen)
g. Previous ventricular cardiac dysrhythmias or proarrhythmic conditions (e.g. bpm <50 / min)
h. Concomitant use of digoxin or drugs known to prolong the QT interval (class IA and III antiarrhythmics, tricyclic antidepressants, antipsychotics, halofantrine), insulin or oral hypoglycaemic agents, phenylbutazone, cyclosporine, mefloquine or other antimalarial drugs, anti-septal drugs
I. severe chronic renal failure (creatinine clearance <10 ml / min)
5. Hydroxychloroquine treatment at any dose, and for any duration and motivation in the last 6 months
6. Previous diagnosis of COVID-19 or previous symptoms suggestive of disease

1.Presenza di co-morbilità o assunzione concomitante di farmaci che possono interferire col rischio di contrarre l’infezione o influenzarne il decorso: diabete, insufficienza cardiaca, patologie neoplastiche, ecc)
2.Trattamenti immunoattivi in corso
3.Stato di gravidanza e allattamento
4.Controindicazioni all’utilizzo di idrossiclorochina:
a.Storia di ipersensibilità o allergia ad idrossiclorochina
b.Deficit di glocosio-6 fosfato deidrogenasi
c.Porfiria
d.Psoriasi
e.Peso < 40 kg
f.Pregressa riferita retinopatia o disturbi del campo visivo o concomitante assunzione di farmaci noti per indurre retinopatia (es tamoxifene)
g.Pregresse disritmie cardiache ventricolari o condizioni proaritmiche (es bpm< 50/min)
h.Utilizzo concomitante di digossina o di farmaci noti per prolungare l’intervallo QT (antiaritmici di classe IA e III, antidepressivi triciclici, antipsicotici, alofantrina), insulina o ipoglicemizzanti orali, fenilbutazone, ciclosporina, meflochina o altri antimalarici, farmaci antiepilettici
i.Insufficienza renale cronica di grado severo (clearance della creatinina < 10 ml/min)
5.Assunzione di idrossiclorochina per qualsiasi dose, durata e motivazione negli ultimi 6 mesi
6.Pregressa diagnosi di COVID-19 o pregressi sintomi suggestivi di malattia

E.5 End points

E.5.1

Primary end point(s)

• Proportion of hydroxychloroquine treated subjects treated with SARS-CoV-2 positive nasopharyngeal swab compared to controls

• Proporzione dei soggetti trattati con idrossiclorochina con tampone nasofaringeo positivo per SARS-CoV-2 rispetto ai controlli

E.5.1.1

Timepoint(s) of evaluation of this end point

At days +14 and +28 from the start of the treatment

Nei giorni +14 e +28 dall’inizio del trattamento

E.5.2

Secondary end point(s)

• Proportion of hydroxychloroquine treated subjects admitted to an intensive care unit for COVID-19, compared to controls; • Proportion of hydroxychloroquine treated subjects interstitial pneumonia typical of COVID-19, compared to controls; • Proportion of adverse and severe adverse events in hydroxychloroquine treated subjects compared to controls; • Proportion of hydroxychloroquine treated subjects with two or more typical COVID-19 clinical manifestations (dry cough, dyspnoea, fever, pharyngodynia, myalgias, dysgeusia or anosmia, conjunctivitis, nausea, vomiting or diarrhea), compared to controls; • Proportion of hydroxychloroquine treated subjects with SARS-CoV-2 specific antibodies, compared to controls; • Proportion of hydroxychloroquine treated subjects hospitalized for COVID-19, compared to controls

• Proporzione dei soggetti trattati con idrossiclorochina che accedono alle cure intensive per COVID-19 rispetto ai controlli; • Proporzione dei soggetti trattati con idrossiclorochina con polmonite interstiziale da SARS-CoV-2 rispetto ai controlli; • Proporzione dei soggetti in trattamento di profilassi con idrossiclorochina che presentano eventi avversi ed eventi avversi gravi rispetto ai controlli; • Proporzione dei soggetti trattati con idrossiclorochina con due o più manifestazioni cliniche tipiche di COVID-19 (tosse secca, dispnea, febbre, faringodinia, mialgie, disgeusia o anosmia, congiuntivite, nausea vomito o diarrea) rispetto ai controlli; • Proporzione dei soggetti trattati con idrossiclorochina con positività degli anticorpi anti SARS-CoV-2 rispetto ai controlli; • Proporzione dei soggetti trattati con idrossiclorochina ospedalizzati per COVID-19 rispetto ai controlli

E.5.2.1

Timepoint(s) of evaluation of this end point

At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day 28 + 14 from the start of treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine

Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina; Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina; Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina; Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina; Giorno 28 + 14 dall’inizio del trattamento con idrossiclorochina; Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

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

Yes

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Solo Dispositivi di Protezione Individuale

Personal Protective Equipment only

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:

950

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

Yes

F.3.2

Patients

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

1000

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1000

F.4.2.2

In the whole clinical trial

1000

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)

Normal clinical practice

Normale pratica clinica

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

2020-04-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-06

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

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