Evaluation of ADG20 for the Prevention of COVID-19

NCT04859517 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: ADG20-PREV-001
• Study Type: interventional
• Target: 2,582
• Locations: 9 countries
• Sites: 95

Brief Summary

This placebo-controlled study is intended to evaluate ADG20's safety and ability to prevent COVID-19 infection.

Conditions

COVID-19

Keywords

Adintrevimab, ADG20, COVID-19, prevention, prophylaxis

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)

  RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.

  Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier

• Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)

  RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCR test from a nasopharyngeal or saliva sample accompanied by protocol-defined COVID-19 symptoms occurring within 14 days from the sample collection date. Any COVID-19-related hospitalization with a positive local SARS-CoV-2 test (within 14 days) or all-cause death are counted toward the endpoint.

  Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier

• Solicited Injection Site Reactions (PEP, PrEP)

  Percentage of participants with at least one solicited injection site reaction

  Day 1 through Day 4

• Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)

  Any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment; includes solicited injection site reactions

  Day 1 through 14 Months or 25Jul2022, whichever is earlier

Secondary Outcomes (22)

• Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)

  Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier

• Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP)

  Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier

• Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP)

  Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier

• Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP)

  Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier

• Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP)

  Day 1 through 6 Months or emergence of Omicron (15-Dec-2021), whichever is earlier

Study Arms (2)

ADG20

EXPERIMENTAL

Participants will be dosed on Day 1 with ADG20 IM

Drug: ADG20

Placebo

PLACEBO COMPARATOR

Participants will be dosed on Day 1 with placebo IM

Drug: Placebo

Interventions

ADG20 DRUG

Single dose of ADG20

ADG20

Placebo DRUG

Single dose of placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Tests negative for current or previous SARS-CoV-2 infection by RT-PCR and serology (Pre-exposure population only)
• Is at high risk of SARS-CoV-2 infection as assessed by the Investigator:
• Post-exposure population: exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). Note: Participants with recent exposure to a laboratory-confirmed index case must be asymptomatic and randomized within 5 days (120 hours) of collection of the index case's positive SARS-CoV-2 diagnostic test.
• Pre-exposure population: Occupational, housing, recreational and/or social conditions that are likely to increase risk of exposure to SARS-CoV-2.
• Agrees to defer receipt of COVID-19 vaccination for minimum of 180 days (6 months) after dosing

You may not qualify if:

• Has received (1) a SARS-CoV-2 vaccine, (2) mAb or (3) convalescent plasma from a person who has recovered from COVID-19 or prior participation in SARS-CoV2 vaccine, convalescent plasma, or mAb clinical trial any time prior to participation in the study.
• Receipt of any investigational product within 30 days or 5 half lives before the day of enrollment.
• Is acutely ill or febrile 72 hours before or at Screening or has other COVID-19 symptoms including cough, fatigue, muscle or body aches, headache, or loss of taste or smell. Fever is defined as a body temperature ≥38.0°C (≥100.4°F).
• Has received or plans to receive a non-COVID-19 vaccine within 28 days before or after dosing (except for seasonal influenza vaccine, which is not permitted within 14 days before or after dosing).

Sponsors & Collaborators

• Invivyd, Inc.: lead

Study Sites (95)

Invivyd Investigative Site

Birmingham, Alabama, 35209, United States

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Tucson, Arizona, 85745, United States

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Fayetteville, Arkansas, 72701, United States

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North Little Rock, Arkansas, 72223, United States

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Banning, California, 92220, United States

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Chula Vista, California, 91911, United States

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Culver City, California, 90230, United States

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Escondido, California, 92025, United States

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Fullerton, California, 92835, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90036, United States

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Modesto, California, 95350, United States

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Palm Springs, California, 92262, United States

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San Diego, California, 92103, United States

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Clearwater, Florida, 33756, United States

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Edgewater, Florida, 32132, United States

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Hialeah, Florida, 33012, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33176, United States

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Miami, Florida, 33186, United States

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Mt. Dora, Florida, 32757, United States

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North Miami Beach, Florida, 33169, United States

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Ormond Beach, Florida, 32174, United States

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Pembroke Pines, Florida, 33026, United States

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Sunrise, Florida, 33325, United States

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Tampa, Florida, 33603, United States

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The Villages, Florida, 32159, United States

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West Palm Beach, Florida, 33409, United States

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Hinesville, Georgia, 31313, United States

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Lawrenceville, Georgia, 30044, United States

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Pearl City, Hawaii, 96782, United States

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Chicago, Illinois, 60607, United States

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Oak Brook, Illinois, 60523, United States

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Owensboro, Kentucky, 42303, United States

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Marrero, Louisiana, 70072, United States

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New Orleans, Louisiana, 70118, United States

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Rockville, Maryland, 20855, United States

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Burlington, Massachusetts, 01803, United States

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Caro, Michigan, 48723, United States

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Grosse Pointe Woods, Michigan, 48236, United States

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Missoula, Montana, 59808, United States

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Albuquerque, New Mexico, 87102, United States

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New York, New York, 11201, United States

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Charlotte, North Carolina, 28208, United States

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Shelby, North Carolina, 28150, United States

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Beachwood, Ohio, 44122, United States

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Cincinnati, Ohio, 54242, United States

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Dresden, Ohio, 43821, United States

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Middleburg Heights, Ohio, 44130, United States

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Yukon, Oklahoma, 73099, United States

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Medford, Oregon, 97504, United States

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West Columbia, South Carolina, 29169, United States

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Jackson, Tennessee, 38305, United States

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Milan, Tennessee, 38358, United States

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Nashville, Tennessee, 37203, United States

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Beaumont, Texas, 77706, United States

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College Station, Texas, 77845, United States

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Corpus Christi, Texas, 78412, United States

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Houston, Texas, 77022, United States

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Houston, Texas, 77087, United States

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Hurst, Texas, 76054, United States

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Mesquite, Texas, 75149, United States

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Sugar Land, Texas, 77479, United States

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St. George, Utah, 84790, United States

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West Jordan, Utah, 84088, United States

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Richmond, Virginia, 23226, United States

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Ciudad Autonoma de Buenos Aire, Buenos Aires, C1426ABP, Argentina

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Mar del Plata, Buenos Aires, B7600FZO, Argentina

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Munro, Buenos Aires, B1605FRE, Argentina

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Ramos Mejía, Buenos Aires, B1704ETD, Argentina

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Rosario, Santa Fe Province, S2000, Argentina

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Rosario, Sante Fe, S2000, Argentina

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Ostrava, 708 00, Czechia

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Prague, 158 00, Czechia

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Rychnov nad Kněžnou, 516 01, Czechia

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Batumi, 6000, Georgia

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Kutaisi, 4600, Georgia

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Rustavi, 3700, Georgia

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Tbilisi, 0179, Georgia

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Tbilisi, 0180, Georgia

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Tbilisi, 0186, Georgia

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Tbilisi, 0197, Georgia

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Berlin, 10629, Germany

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Chisinau, 2025, Moldova

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Kajetany, 05-830, Poland

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Lodz, 90-302, Poland

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Lublin, 20-412, Poland

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Siedlce, 08-110, Poland

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Skierniewice, 96-100, Poland

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Swidnica, 58-100, Poland

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Warsaw, 02-793, Poland

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Zamość, 22-400, Poland

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Bucharest, 021105, Romania

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Adagio Investigative Site

Kyiv, 01103, Ukraine

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Invivyd Investigative Site

Kyiv, 01135, Ukraine

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Related Publications (3)

• Ison MG, Weinstein DF, Dobryanska M, Holmes A, Phelan AM, Li Y, Gupta D, Narayan K, Tosh K, Hershberger E, Connolly LE, Yalcin I, Campanaro E, Hawn P, Schmidt P; EVADE Study Group. Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE). Open Forum Infect Dis. 2023 Jun 13;10(7):ofad314. doi: 10.1093/ofid/ofad314. eCollection 2023 Jul.

  PMID: 37496612 DERIVED

• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

  PMID: 35713300 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

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

Results Point of Contact

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

ClinicalTrials@invivyd.com

17818190080

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 remain blinded to each participant's assigned study treatment throughout the course of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: April 27, 2021
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); MO (1); GE (7); CZ (3); US (66); AR (6); RO (1); UA (2); PL (8)