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Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (STAMP)

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ADG20
Normal saline
Sponsored by
Invivyd, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization
  • Has had symptoms consistent with COVID-19 with onset 5 days before randomization
  • Has one or more COVID-19-related signs or symptoms on the day of randomization
  • Phase 2: Is an adult aged 18 years and above
  • Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening

Exclusion Criteria:

  • Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization.
  • Has severe COVID-19 or is on supplemental oxygen
  • Has a history of a positive SARS-CoV-2 antibody serology test
  • Has participated, within the last 30 days, in a clinical study involving an investigational intervention
  • 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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

  • Adagio Investigative Site
  • Adagio Investigative Site
  • Adagio Investigative Site
  • Adagio Investigative Site
  • Adagio Investigative Site
  • Adagio Investigative Site
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  • Adagio Investigative Site
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  • Adagio Investigative Site
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  • Adagio Investigative Site
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  • Adagio Investigative Site
  • Adagio Investigative Site
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  • Adagio Investigative Site
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  • Adagio Investigative Site
  • Adagio Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ADG20 IM

Placebo IM

Arm Description

Participants will be dosed on Day 1 with ADG20 IM

Participants will be dosed on Day 1 with placebo IM

Outcomes

Primary Outcome Measures

Incidence of COVID-19 related hospitalizations or all-cause death
Incidence of treatment-emergent adverse events
Incidence of solicited injection site reactions
Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation)
Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure)

Secondary Outcome Measures

Incidence of COVID-19 -related medically attended visits
Incidence of COVID-19 -related emergency room visits, COVID-19-related hospitalization, or all cause-death
Incidence of severe/critical COVID-19 or all cause death
Time to sustained recovery defined as sustained improvement or resolution of COVID-19 symptoms
Incidence of all-cause mortality
Time to sustained resolution of COVID-19 symptoms as measured in the Daily COVID-19 Symptom Diary
Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) assessed by RT-qPCR from saliva samples (and NP samples for Day 7)
Duration of SARS-CoV-2 shedding assessed by RT-qPCR from saliva samples
Viral load >5 (log10 copies/mL) based on nasopharyngeal sampling
SARS-CoV-2 viral clearance assessed by RT-qPCR from saliva samples (and NP samples for Day 7)
SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples
Incidence of treatment emergent adverse events
Number of participants with potentially clinically significant (PCS) changes from baseline in clinical laboratory test (PCS defined per statistical analysis plan)
Number of participants with potentially clinically significant (PCS) changes from baseline in vital sign parameters (PCS defined per statistical analysis plan)
Assessment of PK Parameter: Cmax for ADG20
Assessment of PK Parameter: Time to Cmax (Tmax) for ADG20
Assessment of PK Parameter: Area under the curve for ADG20
Assessment of PK Parameter: Clearance of ADG20
Assessment of PK Parameter: volume of distribution of ADG20
Assessment of PK Parameter: Half-life of ADG20
Incidence of ADA to ADG20
Genotypic characterization of viral isolates for reduced susceptibility to ADG20

Full Information

First Posted
March 17, 2021
Last Updated
November 22, 2022
Sponsor
Invivyd, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04805671
Brief Title
Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
Acronym
STAMP
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
All primary efficacy data has been collected and analyzed. Based on the safety data gathered to date, it has been determined that continued participation by study subjects would not yield any additional beneficial safety information.
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
November 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Invivyd, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The investigator, participant and sponsor personnel involved in study intervention and study evaluation will be unaware of the intervention assignments. Investigators will remain blinded to each participant's assigned study treatment throughout the course of the study.
Allocation
Randomized
Enrollment
417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADG20 IM
Arm Type
Experimental
Arm Description
Participants will be dosed on Day 1 with ADG20 IM
Arm Title
Placebo IM
Arm Type
Placebo Comparator
Arm Description
Participants will be dosed on Day 1 with placebo IM
Intervention Type
Drug
Intervention Name(s)
ADG20
Intervention Description
Single dose of ADG20
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Single dose of normal saline
Primary Outcome Measure Information:
Title
Incidence of COVID-19 related hospitalizations or all-cause death
Time Frame
Through Day 29
Title
Incidence of treatment-emergent adverse events
Time Frame
Through day 29
Title
Incidence of solicited injection site reactions
Time Frame
Through Day 4
Title
Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation)
Time Frame
Through Day 29
Title
Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure)
Time Frame
Through Day 29
Secondary Outcome Measure Information:
Title
Incidence of COVID-19 -related medically attended visits
Time Frame
Through Day 29
Title
Incidence of COVID-19 -related emergency room visits, COVID-19-related hospitalization, or all cause-death
Time Frame
Through Day 29
Title
Incidence of severe/critical COVID-19 or all cause death
Time Frame
Through Day 29
Title
Time to sustained recovery defined as sustained improvement or resolution of COVID-19 symptoms
Time Frame
Through Day 29
Title
Incidence of all-cause mortality
Time Frame
Through Day 29, Day 60 and Day 90
Title
Time to sustained resolution of COVID-19 symptoms as measured in the Daily COVID-19 Symptom Diary
Time Frame
Through Day 29
Title
Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) assessed by RT-qPCR from saliva samples (and NP samples for Day 7)
Time Frame
Days 3, 5, 7, 11 and 14 (saliva); Day 7 (NP swab)
Title
Duration of SARS-CoV-2 shedding assessed by RT-qPCR from saliva samples
Time Frame
Through Day 29
Title
Viral load >5 (log10 copies/mL) based on nasopharyngeal sampling
Time Frame
on Day 7 (+/- 1)
Title
SARS-CoV-2 viral clearance assessed by RT-qPCR from saliva samples (and NP samples for Day 7)
Time Frame
Days 5, 7, 11, 14, 21, and 29 (saliva); Day 7 (NP swab)
Title
SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples
Time Frame
Baseline to Day 29
Title
Incidence of treatment emergent adverse events
Time Frame
14 months
Title
Number of participants with potentially clinically significant (PCS) changes from baseline in clinical laboratory test (PCS defined per statistical analysis plan)
Time Frame
14 Months
Title
Number of participants with potentially clinically significant (PCS) changes from baseline in vital sign parameters (PCS defined per statistical analysis plan)
Time Frame
14 Months
Title
Assessment of PK Parameter: Cmax for ADG20
Time Frame
11 Months
Title
Assessment of PK Parameter: Time to Cmax (Tmax) for ADG20
Time Frame
11 Months
Title
Assessment of PK Parameter: Area under the curve for ADG20
Time Frame
11 Months
Title
Assessment of PK Parameter: Clearance of ADG20
Time Frame
11 Months
Title
Assessment of PK Parameter: volume of distribution of ADG20
Time Frame
11 Months
Title
Assessment of PK Parameter: Half-life of ADG20
Time Frame
11 Months
Title
Incidence of ADA to ADG20
Time Frame
11 months
Title
Genotypic characterization of viral isolates for reduced susceptibility to ADG20
Time Frame
Through Day 29

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization Has had symptoms consistent with COVID-19 with onset 5 days before randomization Has one or more COVID-19-related signs or symptoms on the day of randomization Phase 2: Is an adult aged 18 years and above Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening Exclusion Criteria: Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization. Has severe COVID-19 or is on supplemental oxygen Has a history of a positive SARS-CoV-2 antibody serology test Has participated, within the last 30 days, in a clinical study involving an investigational intervention 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 NOTE: Other protocol defined inclusion/exclusion criteria apply
Facility Information:
Facility Name
Adagio Investigative Site
City
Estomba
State/Province
Buenos Aires
ZIP/Postal Code
8118
Country
Argentina
Facility Name
Adagio Investigative Site
City
Munro
State/Province
Buenos Aires
ZIP/Postal Code
1605
Country
Argentina
Facility Name
Adagio Investigative Site
City
Río Cuarto
State/Province
Córdoba
ZIP/Postal Code
5800
Country
Argentina
Facility Name
Adagio Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2013DTC
Country
Argentina
Facility Name
Adagio Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2013KDT
Country
Argentina
Facility Name
Adagio Investigative Site
City
San Miguel De Tucumán
State/Province
Tucumán
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Adagio Investigative Site
City
Mar del Plata
ZIP/Postal Code
B7602DCK
Country
Argentina
Facility Name
Adagio Investigative Site
City
Salvador
State/Province
Bahia
ZIP/Postal Code
2152
Country
Brazil
Facility Name
Adagio Investigative Site
City
Taguatinga
State/Province
Distrito Federal
ZIP/Postal Code
72119-900
Country
Brazil
Facility Name
Adagio Investigative Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Adagio Investigative Site
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-120
Country
Brazil
Facility Name
Adagio Investigative Site
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Adagio Investigative Site
City
São Paulo
ZIP/Postal Code
13059-900
Country
Brazil
Facility Name
Adagio Investigative Site
City
Dupnitsa
State/Province
Kjustendil
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Adagio Investigative Site
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
Adagio Investigative Site
City
Samokov
State/Province
Sofia
ZIP/Postal Code
2000
Country
Bulgaria
Facility Name
Adagio Investigative Site
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Adagio Investigative Site
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Adagio Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Adagio Investigative Site
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Adagio Investigative Site
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Adagio Investigative Site
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Adagio Investigative Site
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50668
Country
Germany
Facility Name
Adagio Investigative Site
City
Koblenz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Adagio Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Adagio Investigative Site
City
Patra
State/Province
Achaïa
ZIP/Postal Code
26500
Country
Greece
Facility Name
Adagio Investigative Site
City
Athens
State/Province
Attiki
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Adagio Investigative Site
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Adagio Investigative Site
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Adagio Investigative Site
City
Athens
State/Province
Attiki
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Adagio Investigative Site
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
Adagio Investigative Site
City
Ioánnina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Adagio Investigative Site
City
Níkaia
ZIP/Postal Code
184 54
Country
Greece
Facility Name
Adagio Investigative Site
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Adagio Investigative Site
City
Székesfehérvár
State/Province
Fejér
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Adagio Investigative Site
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Adagio Investigative Site
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
Adagio Investigative Site
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-414
Country
Poland
Facility Name
Adagio Investigative Site
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
53-149
Country
Poland
Facility Name
Adagio Investigative Site
City
Lódz
State/Province
Lódzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Adagio Investigative Site
City
Skierniewice
State/Province
Lódzkie
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Adagio Investigative Site
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Adagio Investigative Site
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
21105
Country
Romania
Facility Name
Adagio Investigative Site
City
Matjhabeng
State/Province
Free State
ZIP/Postal Code
9459
Country
South Africa
Facility Name
Adagio Investigative Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Adagio Investigative Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Adagio Investigative Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2194
Country
South Africa
Facility Name
Adagio Investigative Site
City
Kempton Park
State/Province
Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Adagio Investigative Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
181
Country
South Africa
Facility Name
Adagio Investigative Site
City
Rustenburg
State/Province
North - West
ZIP/Postal Code
0299
Country
South Africa
Facility Name
Adagio Investigative Site
City
Sol Plaatje
State/Province
Northern Cape
ZIP/Postal Code
8301
Country
South Africa
Facility Name
Adagio Investigative Site
City
Three Rivers
State/Province
Vereeniging
ZIP/Postal Code
1938
Country
South Africa
Facility Name
Adagio Investigative Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Adagio Investigative Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Adagio Investigative Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Adagio Investigative Site
City
George
State/Province
Western Cape
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Adagio Investigative Site
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Adagio Investigative Site
City
George
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Adagio Investigative Site
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Adagio Investigative Site
City
Dnipro
State/Province
Dnipropetrovs'ka Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Adagio Investigative Site
City
Ivano-Frankivsk
State/Province
Ivano-Frankivs'ka Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Adagio Investigative Site
City
Kherson
State/Province
Khersons'ka Oblast
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Adagio Investigative Site
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Adagio Investigative Site
City
Kyiv
ZIP/Postal Code
1103
Country
Ukraine
Facility Name
Adagio Investigative Site
City
Kyiv
ZIP/Postal Code
3049
Country
Ukraine
Facility Name
Adagio Investigative Site
City
Kyiv
ZIP/Postal Code
4050
Country
Ukraine
Facility Name
Adagio Investigative Site
City
Kyïv
ZIP/Postal Code
03035
Country
Ukraine
Facility Name
Adagio Investigative Site
City
Kyïv
ZIP/Postal Code
04050
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived

Learn more about this trial

Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19

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