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

NCT ID: NCT04805671

Last Updated: 2024-02-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2022-11-03

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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ADG20 IM

Participants will be dosed on Day 1 with ADG20 IM

Group Type EXPERIMENTAL

ADG20

Intervention Type DRUG

Single dose of ADG20

Placebo IM

Participants will be dosed on Day 1 with placebo IM

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Single dose of normal saline

Interventions

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ADG20

Single dose of ADG20

Intervention Type DRUG

Normal saline

Single dose of normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Invivyd, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Adagio Investigative Site

Estomba, Buenos Aires, Argentina

Site Status

Adagio Investigative Site

Munro, Buenos Aires, Argentina

Site Status

Adagio Investigative Site

Río Cuarto, Córdoba Province, Argentina

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Adagio Investigative Site

Rosario, Santa Fe Province, Argentina

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Adagio Investigative Site

Rosario, Santa Fe Province, Argentina

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Adagio Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

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Adagio Investigative Site

Mar del Plata, , Argentina

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Adagio Investigative Site

Salvador, Estado de Bahia, Brazil

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Adagio Investigative Site

Taguatinga, Federal District, Brazil

Site Status

Adagio Investigative Site

Belo Horizonte, Minas Gerais, Brazil

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Adagio Investigative Site

Passo Fundo, Rio Grande do Sul, Brazil

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Adagio Investigative Site

São Paulo, , Brazil

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Adagio Investigative Site

São Paulo, , Brazil

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Adagio Investigative Site

Dupnitsa, Kyustendil, Bulgaria

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Adagio Investigative Site

Samokov, Sofia, Bulgaria

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Adagio Investigative Site

Sofia, Sofia-Grad, Bulgaria

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Adagio Investigative Site

Blagoevgrad, , Bulgaria

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Adagio Investigative Site

Montana, , Bulgaria

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Adagio Investigative Site

Pleven, , Bulgaria

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Adagio Investigative Site

Rousse, , Bulgaria

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Adagio Investigative Site

Stara Zagora, , Bulgaria

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Adagio Investigative Site

Frankfurt am Main, Hesse, Germany

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Adagio Investigative Site

Cologne, North Rhine-Westphalia, Germany

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Adagio Investigative Site

Koblenz, Rhineland-Palatinate, Germany

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Adagio Investigative Site

Berlin, , Germany

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Adagio Investigative Site

Pátrai, Achaïa, Greece

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Adagio Investigative Site

Athens, Attica, Greece

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Adagio Investigative Site

Athens, Attica, Greece

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Adagio Investigative Site

Athens, Attica, Greece

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Adagio Investigative Site

Athens, Attica, Greece

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Adagio Investigative Site

Heraklion, Crete, Greece

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Adagio Investigative Site

Ioannina, , Greece

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Adagio Investigative Site

Nikaia, , Greece

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Adagio Investigative Site

Szeged, Csongrád megye, Hungary

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Adagio Investigative Site

Székesfehérvár, Fejér, Hungary

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Adagio Investigative Site

Debrecen, Hajdú-Bihar, Hungary

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Adagio Investigative Site

Chisinau, , Moldova

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Adagio Investigative Site

Krakow, Lesser Poland Voivodeship, Poland

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Adagio Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

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Adagio Investigative Site

Wroclaw, Lower Silesian Voivodeship, Poland

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Adagio Investigative Site

Lódz, Lódzkie, Poland

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Adagio Investigative Site

Skierniewice, Lódzkie, Poland

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Adagio Investigative Site

Bucharest, București, Romania

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Adagio Investigative Site

Welkom, Free State, South Africa

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Adagio Investigative Site

Johannesburg, Gauteng, South Africa

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Adagio Investigative Site

Johannesburg, Gauteng, South Africa

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Adagio Investigative Site

Johannesburg, Gauteng, South Africa

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Adagio Investigative Site

Kempton Park, Gauteng, South Africa

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Adagio Investigative Site

Pretoria, Gauteng, South Africa

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Adagio Investigative Site

Tembisa, Gauteng, South Africa

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Adagio Investigative Site

Rustenburg, North West, South Africa

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Adagio Investigative Site

Three Rivers, Vereeniging, South Africa

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Adagio Investigative Site

Cape Town, Western Cape, South Africa

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Adagio Investigative Site

Cape Town, Western Cape, South Africa

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Adagio Investigative Site

George, Western Cape, South Africa

Site Status

Adagio Investigative Site

Somerset West, Western Cape, South Africa

Site Status

Adagio Investigative Site

Worcester, Western Cape, South Africa

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Adagio Investigative Site

George, , South Africa

Site Status

Adagio Investigative Site

Pretoria, , South Africa

Site Status

Adagio Investigative Site

Dnipro, Dnipropetrovsk Oblast, Ukraine

Site Status

Adagio Investigative Site

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status

Adagio Investigative Site

Kherson, Kherson Oblast, Ukraine

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Adagio Investigative Site

Kharkiv, , Ukraine

Site Status

Adagio Investigative Site

Kiyiv, , Ukraine

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Adagio Investigative Site

Kiyiv, , Ukraine

Site Status

Adagio Investigative Site

Kyiv, , Ukraine

Site Status

Adagio Investigative Site

Kyiv, , Ukraine

Site Status

Adagio Investigative Site

Kyiv, , Ukraine

Site Status

Countries

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Argentina Brazil Bulgaria Germany Greece Hungary Moldova Poland Romania South Africa Ukraine

References

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Ison MG, Popejoy M, Evgeniev N, Tzekova M, Mahoney K, Betancourt N, Li Y, Gupta D, Narayan K, Hershberger E, Connolly LE, Yalcin I, Das AF, Genge J, Smith M, Campanaro E, Hawn P, Schmidt P; STAMP Study Group. Efficacy and Safety of Adintrevimab (ADG20) for the Treatment of High-Risk Ambulatory Patients With Mild or Moderate Coronavirus Disease 2019: Results From a Phase 2/3, Randomized, Placebo-Controlled Trial (STAMP) Conducted During Delta Predominance and Early Emergence of Omicron. Open Forum Infect Dis. 2023 May 24;10(6):ofad279. doi: 10.1093/ofid/ofad279. eCollection 2023 Jun.

Reference Type DERIVED
PMID: 37351456 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34473343 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ADG20-TRMT-001

Identifier Type: -

Identifier Source: org_study_id

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