Clinical Trials Register

Summary
EudraCT Number:	2020-000936-23
Sponsor's Protocol Code Number:	C20-15
National Competent Authority:	Norway - NOMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-03-25
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Norway - NOMA

A.2

EudraCT number

2020-000936-23

A.3

Full title of the trial

Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults - DisCoVeRy

A.3.1

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

Safety and efficacy of treatments of COVID-19 in hospitalized adults (DisCoVeRy)

A.3.2

Name or abbreviated title of the trial where available

DisCoVeRy

A.4.1

Sponsor's protocol code number

C20-15

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	Inserm
B.1.3.4	Country	France
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	The European Commission
B.4.2	Country	European Union
B.4.1	Name of organisation providing support	Astra Zeneca
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	Inserm
B.5.2	Functional name of contact point	Christelle Delmas
B.5.3	Address:
B.5.3.1	Street Address	8 rue de la Croix Jarry
B.5.3.2	Town/ city	Paris
B.5.3.4	Country	France
B.5.6	E-mail	christelle.delmas@inserm.fr

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	AZD1061
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 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	No
D.3.11.9	Recombinant medicinal product	Yes
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.IMP: 2
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	AZD8895
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 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	No
D.3.11.9	Recombinant medicinal product	Yes
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
D.8 Placebo: 2
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 infection

E.1.1.1

Medical condition in easily understood language

COVID-19 infection

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	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10084401
E.1.2	Term	COVID-19 respiratory 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

The overall objective of the study is to evaluate the clinical efficacy and safety of
investigational therapeutics relative to the placebo arm among hospitalized
adult patients who have COVID-19. The primary endpoint is subject Ccinical status (on a 7 point ordinal scale) at Day 15

E.2.2

Secondary objectives of the trial

I) Discontinuation of investigational therapeutics
II) Evaluate the virologic efficacy as compared to the
control arm as assessed by:
1. Percent of subjects with detectable SARS-CoV-2 in
NP or lower respiratory tract sample at baseline
(Day 1 pre-treatment) and at Days 3, 8, 15 (while
hospitalized) and 29
2. Normalized quantitative SARS-CoV-2 viral load in
NP or lower respiratory tract sample at baseline
(Day 1 pre-treatment) and at Days 3, 8, 15 (while
hospitalized) and 29
3. Normalized quantitative SARS-CoV-2 viral load in
blood at baseline (Day 1 pre-treatment) and at
Days 3 and 8
4. Detection of variants of SARS-CoV-2 in NP or lower
respiratory tract sample at baseline (Day 1 pretreatment)
and at Days 3, 8, 15 (while hospitalized)
and 29, and in case of transfer into ICU
III) Evaluate AZD7442 pharmacokinetics
IV) Evaluate the immune-inflammatory response during
treatment
V) Evaluate development of anti-drug antibodies
VI) Identify host genetic variants

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Adult ≥18 years of age at the time of enrolment
2. Hospitalized patients with any of the following criteria:
a. the presence of pulmonary rales/crackles on clinical exam OR
b. SpO2 ≤ 94% on room air OR
c. requirement of supplementary oxygen including high flow oxygen
devices or non-invasive ventilation
3. A time between onset of symptoms and randomization of less than 9 days
4. A positive SARS-CoV-2 PCR performed on a NP swab within the 5 days
preceding randomization
5. The result of a rapid antigen test performed on a NP swab within the 6 hours
preceding randomization
6. Contraceptive use by men or women.
a. Male participants: Contraception for male participants is not
required; however, to avoid the transfer of any fluids, all male
participants must use a condom from Day 1 and agree to continue
for 90 days following administration of IMP.
b. Female participants: Women of child-bearing potential must agree
to use contraception for 365 days following administration of IMP.

E.4

Principal exclusion criteria

R1. efusal to participate expressed by patient or legally authorized
representative
2. Need for invasive mechanical ventilation and/or ECMO at the time of
enrolment
3. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal
4. Glomerular filtration rate (GFR) < 15 mL/min or requiring maintenance
dialysis
5. Pregnancy or breast-feeding
6. Anticipated transfer to another hospital, which is not a study site within 72
hours following randomization
7. Known history of allergy or reaction to any component of the study drug
formulation.
8. Previous hypersensitivity, infusion-related reaction, or severe adverse
reaction following administration of a mAb.
9. Any prior receipt of investigational or licensed vaccine or other
mAb/biologic indicated for the prevention of SARS-CoV-2 infection or
COVID-19 or expected receipt in the 30 days following hospital discharge,
according to current recommendation in each country.
10. Any medical condition which, in the judgment of the investigator, could
interfere with the interpretation of the trial results or that preludes to
protocol adherence.

E.5 End points

E.5.1

Primary end point(s)

Clinical status of subject on Day 15:
1. Not hospitalized, no limitations on
activities
2. Not hospitalized, limitation on activities
3. Hospitalized, not requiring supplemental
oxygen
4. Hospitalized, requiring supplemental
oxygen
5. Hospitalized, on non-invasive ventilation
or high flow oxygen devices
6. Hospitalized, on invasive mechanical
ventilation or ECMO
7. Death

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 15

E.5.2

Secondary end point(s)

Time from randomization to sustained
recovery, defined as being discharged
from the index hospitalization, followed by
being alive and at home for 14 consecutive
days prior to Day 90.
For efficacy assessment:
1. Status on an ordinal scale assessed at Day
29, 90, 180 and 365
2. NEWS-2 at baseline (Day 1 pre-treatment),
at Days 3 and 8, 15 (if patient is still
hospitalized), and at Days 29
3. Duration of supplemental oxygen (if
applicable)
4. Duration of mechanical ventilation (if
applicable)
5. Mechanical ventilation or death between
baseline and Day 15
6. Date of discharge from hospital
7. Date and cause of death (if applicable)
8. Occurrence of new hospitalization
between discharge from index
hospitalization and Days 90, 180 and 365
9. Occurrence of confirmed re-infection with
SARS-CoV-2 between discharge from index
hospitalization and Days 90, 180 and 365
For safety assessment:
1. SAEs
2. Grade 3 and 4 adverse events
3. Grade 1-2 hypersensitivity-related and
infusion related AEs until D29 visit
4. AEs of Special Interest
5. Discontinuation of investigational
therapeutics (for any reason)

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 15, 29, 90, 180, 365, 456

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

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

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

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

Completion of the last 456th day of data collection

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

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

1240

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

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

2021-05-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-04-16

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2023-10-01

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials