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

NCT04805671 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: ADG20-TRMT-001
• Study Type: interventional
• Target: 399
• Locations: 11 countries
• Sites: 68

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (16)

• Incidence of COVID-19 -Related Medically Attended Visits or All-cause Death

  Through Day 29

• Incidence of COVID-19 -Related Emergency Room Visits, COVID-19-related Hospitalization, or All Cause-death

  Through Day 29

• Incidence of Severe/Critical COVID-19 or All Cause Death

  Through Day 29

• Time to Sustained Recovery Defined as Sustained Improvement or Resolution of COVID-19 Symptoms

  Through Day 29

• Incidence of All-cause Mortality

  Through Day 90

Study Arms (2)

ADG20 IM

EXPERIMENTAL

Participants will be dosed on Day 1 with ADG20 IM

Drug: ADG20

Placebo IM

PLACEBO COMPARATOR

Participants will be dosed on Day 1 with placebo IM

Drug: Normal saline

Interventions

ADG20 DRUG

Single dose of ADG20

ADG20 IM

Normal saline DRUG

Single dose of normal saline

Placebo IM

Eligibility Criteria

• Age: 12 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Invivyd, Inc.: lead

Study Sites (68)

Adagio Investigative Site

Estomba, Buenos Aires, 8118, Argentina

Location

Adagio Investigative Site

Munro, Buenos Aires, 1605, Argentina

Location

Adagio Investigative Site

Río Cuarto, Córdoba Province, 5800, Argentina

Location

Adagio Investigative Site

Rosario, Santa Fe Province, S2013DTC, Argentina

Location

Adagio Investigative Site

Rosario, Santa Fe Province, S2013KDT, Argentina

Location

Adagio Investigative Site

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Adagio Investigative Site

Mar del Plata, B7602DCK, Argentina

Location

Adagio Investigative Site

Salvador, Estado de Bahia, 2152, Brazil

Location

Adagio Investigative Site

Taguatinga, Federal District, 72119-900, Brazil

Location

Adagio Investigative Site

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Adagio Investigative Site

Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

Location

Adagio Investigative Site

São Paulo, 05403-000, Brazil

Location

Adagio Investigative Site

São Paulo, 13059-900, Brazil

Location

Adagio Investigative Site

Dupnitsa, Kyustendil, 2600, Bulgaria

Location

Adagio Investigative Site

Samokov, Sofia, 2000, Bulgaria

Location

Adagio Investigative Site

Sofia, Sofia-Grad, 1510, Bulgaria

Location

Adagio Investigative Site

Blagoevgrad, 2700, Bulgaria

Location

Adagio Investigative Site

Montana, 3400, Bulgaria

Location

Adagio Investigative Site

Pleven, 5800, Bulgaria

Location

Adagio Investigative Site

Rousse, 7000, Bulgaria

Location

Adagio Investigative Site

Stara Zagora, 6003, Bulgaria

Location

Adagio Investigative Site

Frankfurt am Main, Hesse, 60596, Germany

Location

Adagio Investigative Site

Cologne, North Rhine-Westphalia, 50668, Germany

Location

Adagio Investigative Site

Koblenz, Rhineland-Palatinate, 56068, Germany

Location

Adagio Investigative Site

Berlin, 12203, Germany

Location

Adagio Investigative Site

Pátrai, Achaïa, 26500, Greece

Location

Adagio Investigative Site

Athens, Attica, 106 76, Greece

Location

Adagio Investigative Site

Athens, Attica, 115 27, Greece

Location

Adagio Investigative Site

Athens, Attica, 115 28, Greece

Location

Adagio Investigative Site

Athens, Attica, 124 62, Greece

Location

Adagio Investigative Site

Heraklion, Crete, 71110, Greece

Location

Adagio Investigative Site

Ioannina, 45500, Greece

Location

Adagio Investigative Site

Nikaia, 184 54, Greece

Location

Adagio Investigative Site

Szeged, Csongrád megye, 6725, Hungary

Location

Adagio Investigative Site

Székesfehérvár, Fejér, 8000, Hungary

Location

Adagio Investigative Site

Debrecen, Hajdú-Bihar, 4031, Hungary

Location

Adagio Investigative Site

Chisinau, MD-2025, Moldova

Location

Adagio Investigative Site

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Adagio Investigative Site

Wroclaw, Lower Silesian Voivodeship, 50-414, Poland

Location

Adagio Investigative Site

Wroclaw, Lower Silesian Voivodeship, 53-149, Poland

Location

Adagio Investigative Site

Lódz, Lódzkie, 90-302, Poland

Location

Adagio Investigative Site

Skierniewice, Lódzkie, 96-100, Poland

Location

Adagio Investigative Site

Bucharest, București, 21105, Romania

Location

Adagio Investigative Site

Welkom, Free State, 9460, South Africa

Location

Adagio Investigative Site

Johannesburg, Gauteng, 1827, South Africa

Location

Adagio Investigative Site

Johannesburg, Gauteng, 1862, South Africa

Location

Adagio Investigative Site

Johannesburg, Gauteng, 2092, South Africa

Location

Adagio Investigative Site

Kempton Park, Gauteng, 1619, South Africa

Location

Adagio Investigative Site

Pretoria, Gauteng, 0183, South Africa

Location

Adagio Investigative Site

Tembisa, Gauteng, 1632, South Africa

Location

Adagio Investigative Site

Rustenburg, North West, 0299, South Africa

Location

Adagio Investigative Site

Three Rivers, Vereeniging, 1935, South Africa

Location

Adagio Investigative Site

Cape Town, Western Cape, 7405, South Africa

Location

Adagio Investigative Site

Cape Town, Western Cape, 7570, South Africa

Location

Adagio Investigative Site

George, Western Cape, 6529, South Africa

Location

Adagio Investigative Site

Somerset West, Western Cape, 7130, South Africa

Location

Adagio Investigative Site

Worcester, Western Cape, 6850, South Africa

Location

Adagio Investigative Site

George, 6530, South Africa

Location

Adagio Investigative Site

Pretoria, 0001, South Africa

Location

Adagio Investigative Site

Dnipro, Dnipropetrovsk Oblast, 41102, Ukraine

Location

Adagio Investigative Site

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Adagio Investigative Site

Kherson, Kherson Oblast, 73000, Ukraine

Location

Adagio Investigative Site

Kharkiv, 61002, Ukraine

Location

Adagio Investigative Site

Kiyiv, 2002, Ukraine

Location

Adagio Investigative Site

Kiyiv, 3035, Ukraine

Location

Adagio Investigative Site

Kyiv, 1103, Ukraine

Location

Adagio Investigative Site

Kyiv, 3049, Ukraine

Location

Adagio Investigative Site

Kyiv, 4050, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 37351456 DERIVED

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ADG20; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Inquiry
• Organization: INVIVYD, Inc.

ClinicalTrials@invivyd.com

+1 781-819-0080

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo controlled

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 18, 2021
• Study Start: July 26, 2021
• Primary Completion: February 10, 2022
• Study Completion: November 3, 2022
• Last Updated: February 6, 2024
• Results First Posted: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (8); BR (6); MO (1); DE (4); GR (8); RO (1); UA (9); AR (7); PL (5); HU (3); ZA (16)