Clinical Trials Register

Summary
EudraCT Number:	2020-006082-11
Sponsor's Protocol Code Number:	ADG20-TRMT-001
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-09
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2020-006082-11

A.3

Full title of the trial

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP)

Az ADG20 hatásosságának és biztonságosságának értékelésére irányuló II/III. fázisú, randomizált, kettős-vak, placebo-kontrollos vizsgálat enyhe vagy középsúlyos COVID-19-ben szenvedő, ambuláns résztvevők kezelésében (STAMP)

A.3.1

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

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP)

A.4.1

Sponsor's protocol code number

ADG20-TRMT-001

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	Adagio Therapeutics Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Adagio Therapeutics Inc.
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	Adagio Therapeutics Inc.
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	303 Wyman Street, Suite 300
B.5.3.2	Town/ city	Waltham
B.5.3.3	Post code	MA 02451
B.5.3.4	Country	United States
B.5.4	Telephone number	+1781819 0080
B.5.6	E-mail	clinicaltrials@adagiotx.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	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.3.2	Product code	ADG20
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	2516243-50-0
D.3.9.2	Current sponsor code	ADG20
D.3.9.3	Other descriptive name	ADG20
D.3.9.4	EV Substance Code	SUB220836
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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 injection
D.8.4	Route of administration of the placebo	Intramuscular 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

Coronavirus disease 2019

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	10084382
E.1.2	Term	Coronavirus disease 2019
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 ADG20 compared to placebo in the treatment of mild or moderate COVID 19 in participants at high risk of disease progression
- To evaluate the safety and tolerability of ADG20 compared to placebo through Day 29 in participants with mild and moderate COVID-19 and high risk of disease progression

E.2.2

Secondary objectives of the trial

- To evaluate the effect of ADG20 on the following clinical parameters in participants with mild or moderate COVID 19 and high risk of disease progression
o Severity of COVID-19
o COVID-19 related emergency room visits, COVID-19 related hospitalizations, or all cause death
o COVID-19 related medically attended visits
o Time to sustained recovery of COVID-19 symptoms
o All cause mortality
- To evaluate the effect of ADG20 on SARS-CoV-2 viral load and clearance in participants with mild or moderate COVID-19 and high risk of disease progression
- To evaluate the safety and tolerability of ADG20 compared to placebo through Month 14 in participants with mild or moderate COVID-19 and high risk of disease progression
- To evaluate the PK of ADG20 following IM administration
- To evaluate the immunogenicity (ADAs) to ADG20
- To evaluate the emergence of resistance to ADG20

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age:
a. Ph 2: Is an adult aged 18 years and above
b. Ph 3: Is an adult aged 18 years and above or is an adolescent aged 12-17 years (inclusive) and weighing ≥40 kg at the time of screening
2. Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization
3. Has had initial onset of one or more of the following self-reported COVID-19-related signs or symptoms within 5 days prior to randomization:
(temperature ≥38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea)
4. Has one or more of the following COVID-19-related signs or symptoms on the day of randomization
(temperature ≥38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea)
5. Is at high risk of disease progression defined as:
a. Age >55 years
b. Age 18 to ≤55 years with one or more stable preexisting medical conditions as follows
i. Obesity [BMI ≥ 30 kg/m2]
ii. Diabetes (Type 1 or Type 2)
iii. Chronic kidney disease
iv. Chronic lung disease
v. Cardiac disease
vi. Sickle cell disease or thalassemia
vii. Solid organ or blood stem cell transplant recipients
viii. Other immunodeficiency due to underlying illness or immunosuppressant medication
ix. Down Syndrome
x. Stroke or cerebrovascular disease, which affects blood flow to the brain
xi. Substance use disorder
xii. Pregnant (Phase 3 only; after review Ph2 data by iDMC)
c. Age 12 to 17 years (inclusive) with one or more preexisting medical conditions as follows
i. BMI >85th percentile for age and gender based on CDC growth charts
ii. Diabetes (Type 1 or 2)
iii. Chronic kidney disease
iv. Sickle cell disease or thalassemia
v. Congenital or acquired heart disease
vi. Neurodevelopmental disorders
vii. A medically related technological dependence
viii. Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control
ix. Solid organ or blood stem cell transplant recipients
x. Other immunodeficiency due to underlying illness or immunosuppressant medication
xi. Substance use disorder
xii Pregnant (Ph 3 only: enrollment only after Ph2 data reviewed by iDMC)
6. Has been assigned female sex at birth and is of nonchildbearing potential. A female participant who is not of reproductive potential is eligible without requiring the use of contraception and pregnancy testing is not required. This includes female participants who have not undergone menarche or who are documented to be surgically sterile or postmenopausal. Follicle stimulating hormone is not required in postmenopausal females with amenorrhea for >2 years.
7. Has been assigned female sex at birth and is of childbearing potential and fulfills all the following criteria:
a. Has a negative urine or serum pregnancy test at Screening
b. Has practiced adequate contraception for or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1)
c. Has agreed to continue adequate contraception for sexual activity that could lead to pregnancy through 6 months following study drug administration
d. Is not currently breastfeeding
Adequate contraception for participants assigned female sex at birth is defined as consistent and correct use of a highly effective locally approved contraceptive method in accordance with local regulations for contraceptive use in clinical trial participants.
8. Has been assigned male sex at birth with partner(s) of childbearing potential and agree to use contraception, per local regulations, through 6 months after dosing. If their partner is pregnant, males must agree to use a condom. No sperm donation is permitted through 6 months after dosing.
9. Is able to understand and comply with study requirements /procedures (if applicable, with assistance by caregiver, surrogate, or guardian/[LAR]) based on the assessment of the investigator.
10. Is able and willing to provide informed consent. An LAR may be used only in cases where inclusion criterion 9 is able to be fulfilled. In the case of adolescents, informed assent must also be obtained as required by local guidelines.

E.4

Principal exclusion criteria

1. Is currently hospitalized or in the opinion of the investigator requires urgent medical attention or is anticipated to require hospitalization within 48 hours of randomization
2. Has oxygen saturation (SpO2) ≤93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300 mmHg, respiratory rate ≥30 per minute, or heart rate ≥125 per minute.
3. Is on supplemental oxygen therapy at the time of randomization for any reason or in the opinion of the investigator anticipated impending need for mechanical ventilation.
4. Has a history of a positive SARS CoV 2 antibody serology test. Note: serology testing is not required for study eligibility, exclusion criterion is based on known history only.
5. Has participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
6. Has known allergy/sensitivity or hypersensitivity to study drug, including excipients.
7. Has received a SARS CoV 2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID 19 any time prior to participation in the study.
8. Has a known active co infection (eg, influenza, urinary tract infection, etc).
9. Has any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study including but not limited to any co-morbidity requiring surgery or conditions considered life-threatening within 29 days.
10. Has a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
11. Is or has an immediate family member (eg, spouse, sibling, child, guardian/LAR, parent) who is an investigator or site or sponsor staff (or designee) directly involved with the study.

E.5 End points

E.5.1

Primary end point(s)

- COVID-19 related hospitalization or all-cause death through Day 29
- Assessment of safety through Day 29 based on:
o The incidence of TEAEs
o Incidence of solicited injection site reactions through Day 4
o Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation)
o Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure)

E.5.1.1

Timepoint(s) of evaluation of this end point

- day 29
- day 4 and day 29

E.5.2

Secondary end point(s)

o Severe/critical COVID-19 or all-cause death through Day 29
o COVID 19-related emergency room visits, COVID-19 related hospitalization, or all-cause death through Day 29
o COVID-19-related medically attended visit (telemedicine, physician office, urgent care center, emergency room, hospitalization) or all-cause death through Day 29
o Time to sustained recovery defined as sustained improvement or resolution of COVID 19 symptoms through Day 29
o All cause mortality through Day 29, Day 60, and Day 90
o Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to Day 7 (±1) assessed by RT qPCR from NP samples
o Viral load >5 (log10 copies/mL) on Day 7 (±1) based on nasopharyngeal sampling (Ph 3)
o Duration of SARS-CoV-2 viral shedding from Day 1 through Day 29 assessed by RT-qPCR from saliva samples
o Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to Days 3, 5, 7, 11, and 14 assessed by RT-qPCR from saliva samples
o SARS-CoV-2 viral clearance (Days 5, 7, 11, 14, 21, and 29) assessed by RT-qPCR from saliva samples (and NP samples for Day 7)
o SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples from baseline to Day 7, 11, 14, 21 and 29
- Assessment of safety through Month 14 based on:
o The incidence of TEAEs
o Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation)
o Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure)
- PK parameters of ADG20: As data permit, Cmax, Tmax, AUC 0-last, AUC 0-inf, CL, Vd, and T1/2. Additional PK parameters may be calculated as data permit
- Incidence of ADAs against ADG20
- Genotypic characterization of viral isolates for reduced susceptibility to ADG20, with phenotypic evaluation as appropriate

Exploratory
- Effect of baseline SARS CoV 2 specific antibody response on select clinical outcomes
- The level of viral load leading to the following adverse clinical outcomes:
• COVID-19 related hospitalization or all-cause death through Day 29
• COVID 19-related emergency room visits, COVID-19 related hospitalization, or all-cause death through Day 29
• Severe/critical COVID-19 or all-cause death through Day 29
o Participants with symptomatic COVID-19 among household contacts
o Participants with asymptomatic SARS-CoV-2 infection among household contacts
o COVID 19-related mortality through Day 29
o Time to improvement of COVID-19 symptoms through Day 29
o Time to sustained resolution of COVID 19 symptoms through Day 29
o Incidence of PASC at Day 60, Day 90, and Month 6

E.5.2.1

Timepoint(s) of evaluation of this end point

- day 29
- days 29, 60, 90
- day 7
- day 1, day 29
- days 3, 5, 8, 11, 14
- days 5, 7, 11, 14, 21, 29
- day 7, 11, 14, 21, 29
- month 14

Exploratory
- day 29
- day 60, 90, and month 6

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

Yes

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)

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

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

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

Brazil

Chile

Mexico

Peru

South Africa

Turkey

Ukraine

Bulgaria

Germany

Greece

Hungary

Poland

Argentina

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 subject last visit (includes follow up visit)

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

780

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

284

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

250

F.4.2.2

In the whole clinical trial

1084

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

2021-07-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-08

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

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