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

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)

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: ADG20; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Mar del Plata, Argentina, B7602DCK
    • Adagio Investigative Site
  • Buenos Aires
    • Estomba, Buenos Aires, Argentina, 8118
      • Adagio Investigative Site
    • Munro, Buenos Aires, Argentina, 1605
      • Adagio Investigative Site
  • Córdoba
    • Río Cuarto, Córdoba, Argentina, 5800
      • Adagio Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2013DTC
      • Adagio Investigative Site
    • Rosario, Santa Fe, Argentina, S2013KDT
      • Adagio Investigative Site
  • Tucumán
    • San Miguel De Tucumán, Tucumán, Argentina, 4000
      • Adagio Investigative Site
• Brazil
  • São Paulo, Brazil, 05403-000
    • Adagio Investigative Site
  • São Paulo, Brazil, 13059-900
    • Adagio Investigative Site
  • Bahia
    • Salvador, Bahia, Brazil, 2152
      • Adagio Investigative Site
  • Distrito Federal
    • Taguatinga, Distrito Federal, Brazil, 72119-900
      • Adagio Investigative Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Adagio Investigative Site
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-120
      • Adagio Investigative Site
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Adagio Investigative Site
  • Montana, Bulgaria, 3400
    • Adagio Investigative Site
  • Pleven, Bulgaria, 5800
    • Adagio Investigative Site
  • Ruse, Bulgaria, 7000
    • Adagio Investigative Site
  • Stara Zagora, Bulgaria, 6003
    • Adagio Investigative Site
  • Kjustendil
    • Dupnitsa, Kjustendil, Bulgaria, 2600
      • Adagio Investigative Site
  • Sofia
    • Samokov, Sofia, Bulgaria, 2000
      • Adagio Investigative Site
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1510
      • Adagio Investigative Site
• Germany
  • Berlin, Germany, 12203
    • Adagio Investigative Site
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60596
      • Adagio Investigative Site
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 50668
      • Adagio Investigative Site
  • Rheinland-Pfalz
    • Koblenz, Rheinland-Pfalz, Germany, 56068
      • Adagio Investigative Site
• Greece
  • Ioánnina, Greece, 45500
    • Adagio Investigative Site
  • Níkaia, Greece, 184 54
    • Adagio Investigative Site
  • Achaïa
    • Patra, Achaïa, Greece, 26500
      • Adagio Investigative Site
  • Attiki
    • Athens, Attiki, Greece, 106 76
      • Adagio Investigative Site
    • Athens, Attiki, Greece, 115 27
      • Adagio Investigative Site
    • Athens, Attiki, Greece, 115 28
      • Adagio Investigative Site
    • Athens, Attiki, Greece, 124 62
      • Adagio Investigative Site
  • Crete
    • Heraklion, Crete, Greece, 71110
      • Adagio Investigative Site
• Hungary
  • Csongrád
    • Szeged, Csongrád, Hungary, 6725
      • Adagio Investigative Site
  • Fejér
    • Székesfehérvár, Fejér, Hungary, 8000
      • Adagio Investigative Site
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4031
      • Adagio Investigative Site
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, MD-2025
    • Adagio Investigative Site
• Poland
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 50-414
      • Adagio Investigative Site
    • Wroclaw, Dolnoslaskie, Poland, 53-149
      • Adagio Investigative Site
  • Lódzkie
    • Lódz, Lódzkie, Poland, 90-302
      • Adagio Investigative Site
    • Skierniewice, Lódzkie, Poland, 96-100
      • Adagio Investigative Site
  • Malopolskie
    • Kraków, Malopolskie, Poland, 31-501
      • Adagio Investigative Site
• Romania
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 21105
      • Adagio Investigative Site
• South Africa
  • George, South Africa, 6530
    • Adagio Investigative Site
  • Pretoria, South Africa, 0001
    • Adagio Investigative Site
  • Free State
    • Welkom, Free State, South Africa, 9460
      • Adagio Investigative Site
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1827
      • Adagio Investigative Site
    • Johannesburg, Gauteng, South Africa, 1862
      • Adagio Investigative Site
    • Johannesburg, Gauteng, South Africa, 2092
      • Adagio Investigative Site
    • Kempton Park, Gauteng, South Africa, 1619
      • Adagio Investigative Site
    • Pretoria, Gauteng, South Africa, 0183
      • Adagio Investigative Site
    • Tembisa, Gauteng, South Africa, 1632
      • Adagio Investigative Site
  • North - West
    • Rustenburg, North - West, South Africa, 0299
      • Adagio Investigative Site
  • Vereeniging
    • Three Rivers, Vereeniging, South Africa, 1935
      • Adagio Investigative Site
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7570
      • Adagio Investigative Site
    • Cape Town, Western Cape, South Africa, 7405
      • Adagio Investigative Site
    • George, Western Cape, South Africa, 6529
      • Adagio Investigative Site
    • Somerset West, Western Cape, South Africa, 7130
      • Adagio Investigative Site
    • Worcester, Western Cape, South Africa, 6850
      • Adagio Investigative Site
• Ukraine
  • Kharkiv, Ukraine, 61002
    • Adagio Investigative Site
  • Kyiv, Ukraine, 1103
    • Adagio Investigative Site
  • Kyiv, Ukraine, 3049
    • Adagio Investigative Site
  • Kyiv, Ukraine, 4050
    • Adagio Investigative Site
  • Kyïv, Ukraine, 2002
    • Adagio Investigative Site
  • Kyïv, Ukraine, 3035
    • Adagio Investigative Site
  • Dnipropetrovs'ka Oblast
    • Dnipro, Dnipropetrovs'ka Oblast, Ukraine, 41102
      • Adagio Investigative Site
  • Ivano-Frankivs'ka Oblast
    • Ivano-Frankivsk, Ivano-Frankivs'ka Oblast, Ukraine, 76018
      • Adagio Investigative Site
  • Khersons'ka Oblast
    • Kherson, Khersons'ka Oblast, Ukraine, 73000
      • Adagio Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADG20 IM; Participants will be dosed on Day 1 with ADG20 IM	Drug: ADG20; Single dose of ADG20
Placebo Comparator: Placebo IM; Participants will be dosed on Day 1 with placebo IM	Drug: Normal saline; Single dose of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of COVID-19 Related Hospitalizations or All-cause Death	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. Hospitalization is defined as ≥24 hours of acute care in a hospital or acute care facility (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities). All-cause death is defined as death for any reason from Day 1 (postdose) through Day 29.	Through Day 29
Incidence of Treatment-emergent Adverse Events	Proportion of participants with at least one treatment emergent AE	Through day 29
Incidence of Solicited Injection Site Reactions	Proportion of participants with at least one solicited injection site reaction	Through Day 4
Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation)	Proportion of participants with a potentially clinically significant change from baseline in post-baseline laboratory parameters - data presented for any analyte with >/= 2% in any arm	Through Day 29
Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure)	Participants with Potentially Clinically Significant Changes (PCS) From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure) at Any Time Post-Baseline	Through Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ADA to ADG20		11 months
Incidence of COVID-19 -Related Medically Attended Visits or All-cause Death	Proportion of participants with COVID-19-related medically attended visit (telemedicine, physician office, urgent care center, emergency room, hospitalization) or all-cause death through Day 29. In addition to events defined as the primary efficacy endpoint, this endpoint also includes any medically attended visits, in-person, or telemedicine, not specified in the protocol. These include unscheduled in-person or telemedicine visits conducted by the investigator for the purpose of evaluating worsening signs or symptoms attributed to COVID-19 or emergency room, urgent care center or physician office visits, or hospitalization for attention to worsening signs or symptoms attributed to COVID-19, in the opinion of the investigator. Incidence of COVID-19-related medically attended visits or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame.	Through Day 29
Incidence of COVID-19 -Related Emergency Room Visits, COVID-19-related Hospitalization, or All Cause-death	Proportion of participants with any COVID 19-related emergency room visits, COVID-19-related hospitalization, or all cause death through Day 29. Defined as any stay in a hospital or acute care facility regardless of duration (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities) for attention to worsening signs or symptoms attributed to COVID-19 in the opinion of the investigator or all cause death through Day 29. Incidence of COVID-19-related emergency room visits, COVID-19-related hospitalization, or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame.	Through Day 29
Incidence of Severe/Critical COVID-19 or All Cause Death	Proportion of participants with Severe/Critical COVID-19 or all-cause death through Day 29. All-cause death is defined as death for any reason (from Day 1postdose) through Day 29. Severity is based on the investigator's assessment of severity (eCRF COVID-19 Severity Assessment) per the protocol definitions. Incidence of Severe/Critical COVID-19 or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame.	Through Day 29
Time to Sustained Recovery Defined as Sustained Improvement or Resolution of COVID-19 Symptoms	Time to sustained recovery (improvement or resolution) of COVID-19 symptoms through Day 29: Defined as the time from the first dose date to the earliest date when sustained improvement or sustained resolution of COVID-19 symptoms is met (as detailed below) through Day 29. COVID-19 symptoms assessed include fever, chills, cough, sore throat, congestion, shortness of breath/difficulty breathing at rest, shortness of breath/difficulty breathing with exertion, muscle or body aches, fatigue, headache, nausea, vomiting, and diarrhea. Loss of taste/smell is excluded from this analysis.	Through Day 29
Incidence of All-cause Mortality	Defined as death for any reason from Day 1 (postdose). In the overall survival analysis, participants who are alive or lost to follow-up at the time of analysis are censored at the date of last contact.	Through Day 90
Time to Sustained Resolution of COVID-19 Symptoms as Measured in the Daily COVID-19 Symptom Diary	Time to sustained resolution of COVID-19 symptoms through Day 29: Defined as time from the dose date to the first date when all of the defined symptoms are scored as absent with no symptom recurrence or new symptoms, except cough, fatigue, and headache which may be mild or absent, through Day 29.	Through Day 29
Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL) to Day 7 (±1)	Assessed by RT qPCR From NP (Nasopharyngeal) Samples	Day 7 (±1)
Duration of SARS-CoV-2 Shedding Assessed by RT-qPCR From Saliva Samples	Duration of SARS-CoV-2 viral shedding is defined as time from the dose date to the first date the viral load is not detected, ie, below the limit of detection (LOD), and sustained through Day 29. Participants who do not have the defined event or who discontinue study prior to Day 29 are censored at the earlier date of the last viral load assessment or Day 30. Deaths occurring prior to Day 29 were censored at Day 30.	Through Day 29
Viral Load >5 (log10 Copies/mL) Based on Nasopharyngeal Sampling at Day 7	Proportion of participants with Viral load >5 (log10 copies/mL) on Day 7 assessed by RT-qPCR from NP sample.	on Day 7 (+/- 1 Day)
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)	Proportions of SARS-CoV-2 viral clearance (Days 3, 5, 7, 11, 14, 21, and 29) assessed by RT-qPCR from saliva samples: In the mFAS-S, the cumulative proportion of participants with viral clearance (viral load not detected and sustained through Day 29) at Days 3, 5, 7, 11, 14, 21, and 29 will be assessed by RT-qPCR from saliva samples. Participants who have died or discontinued study prior to Day 29 are assumed to have no viral clearance.	Days 5, 7, 11, 14, 21, and 29 (saliva)
SARS-CoV-2 Viral Load AUC Assessed by RT-qPCR From Saliva Samples	The AUC from Day 1 through Day 29 was calculated according to the linear trapezoidal rule using the measured SARS-CoV-2 viral load above the lower limit of quantification. No AUC values will be calculated when Day 1 and/or Day 29 values are missing, or if there are more than 3 values missing in the profile.	Baseline to Day 29
Incidence of Treatment Emergent Adverse Events	An AE is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to the study drug. AEs occurring from when the participant signed the ICF until the Month 14 (EOS) visit or discontinuation from study was recorded	14 months
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan)	A PCS value is defined as any DAIDS grade 4 post-baseline or any increase of 2 or more DAIDS grades post-baseline, except for PCS low creatinine clearance, which is defined as any DAIDS Grade 4 post-baseline or any DAIDS grade shift from 0 to 3. Laboratory parameters not graded by DAIDs will be defined as PCS based on the criteria in the SAP (Appendix K.)	14 Months
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan)		14 Months
Genotypic Characterization of Viral Isolates for Reduced Susceptibility to ADG20 (G504 Mutations)	Post-baseline Treatment-emergent Variations at Amino Acid Positions Associated with Reduced Susceptibility to ADG20 (>/= 15% Allele frequency); data limited to mutations observed.	Through Day 29

Collaborators and Investigators

• Sponsor: Invivyd, Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Efficacy and Safety of Adintrevimab (ADG20) for the Treatment of High-Risk Ambulatory Patients With Mild or Moderate COVID-19

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): November 3, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ADG20-TRMT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No