Clinical trial NCT04859517: Evaluation of ADG20 for the Prevention of COVID-19
Official title: A Phase 2/3 Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID-19 (EVADE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: Adintrevimab, ADG20, COVID-19, prevention, prophylaxis
Lead sponsor: Invivyd, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 2582
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled
Primary purpose: PREVENTION

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

Detailed description: Phase 2/3, multicenter, double-blind, placebo-controlled, randomized study of the mAb ADG20 in the prevention of symptomatic COVID-19 in adults and adolescents with no known history of SARS-CoV-2 infection but whose circumstances place them at increased risk of acquiring SARS-CoV-2 infection and developing symptomatic COVID-19. This objective was independently evaluated in a cohort of participants with reported recent exposure to an individual diagnosed with a SARS-CoV-2 infection (post-exposure prophylaxis) and in a cohort of participants with no reported exposure to SARS-CoV-2 (pre-exposure prophylaxis). These cohorts included participants whose advanced age (≥55 years old) or health status placed them at risk for severe COVID-19 or COVID-19 complications.

Eligibility criteria: Inclusion Criteria:

* 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:

  1. 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.
  2. 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

Exclusion Criteria:

* 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).

NOTE: Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)
timeFrame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)
timeFrame: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Solicited Injection Site Reactions (PEP, PrEP)
timeFrame: Day 1 through Day 4
measure: Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)
timeFrame: Day 1 through 14 Months or 25Jul2022, whichever is earlier
Secondary outcomes:
measure: Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)
timeFrame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP)
timeFrame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP)
timeFrame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP)
timeFrame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP)
timeFrame: Day 1 through 6 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP)
timeFrame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)
timeFrame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)
timeFrame: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP)
timeFrame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP)
timeFrame: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Percentage of Participants With a COVID-19 Related Hospitalization (PEP)
timeFrame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
measure: Percentage of Participants With a COVID-19 Related Hospitalization (PrEP)
timeFrame: Through 28 days from COVID-19-like illness initial visit (CLI Day 1)
measure: COVID-19 Related Mortality (PEP)
timeFrame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
measure: COVID-19 Related Mortality (PrEP)
timeFrame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
measure: All-Cause Mortality (PEP)
timeFrame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
measure: All-Cause Mortality (PrEP)
timeFrame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
measure: Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PEP)
timeFrame: Positive CLI Day 1 sample through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PrEP)
timeFrame: Positive CLI Day 1 sample through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
measure: Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP)
timeFrame: Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier
measure: Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP)
timeFrame: Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier
measure: Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP)
timeFrame: An average of 2 months up to 7 months through cutoff date prior to emergence of Omicron (15-Dec-2021)
measure: Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP)
timeFrame: An average of 2.5 months up to 7.5 months through cutoff date prior to emergence of Omicron (15-Dec-2021)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Invivyd Investigative Site
state: Alabama
city: Tucson
country: United States
facility: Invivyd Investigative Site
state: Arizona
city: Fayetteville
country: United States
facility: Invivyd Investigative Site
state: Arkansas
city: North Little Rock
country: United States
facility: Invivyd Investigative Site
state: Arkansas
city: Banning
country: United States
facility: Invivyd Investigative Site
state: California
city: Chula Vista
country: United States
facility: Invivyd Investigative Site
state: California
city: Culver City
country: United States
facility: Invivyd Investigative Site
state: California
city: Escondido
country: United States
facility: Invivyd Investigative Site
state: California
city: Fullerton
country: United States
facility: Invivyd Investigative Site
state: California
city: Long Beach
country: United States
facility: Invivyd Investigative Site
state: California
city: Los Angeles
country: United States
facility: Invivyd Investigative Site
state: California
city: Modesto
country: United States
facility: Invivyd Investigative Site
state: California
city: Palm Springs
country: United States
facility: Invivyd Investigative Site
state: California
city: San Diego
country: United States
facility: Invivyd Investigative Site
state: California
city: Clearwater
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Edgewater
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Hialeah
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Miami
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Miami
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Miami
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Mount Dora
country: United States
facility: Invivyd Investigative Site
state: Florida
city: North Miami Beach
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Ormond Beach
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Sunrise
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Tampa
country: United States
facility: Invivyd Investigative Site
state: Florida
city: The Villages
country: United States
facility: Invivyd Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Invivyd Investigative Site
state: Florida
city: Hinesville
country: United States
facility: Invivyd Investigative Site
state: Georgia
city: Lawrenceville
country: United States
facility: Invivyd Investigative Site
state: Georgia
city: Pearl City
country: United States
facility: Invivyd Investigative Site
state: Hawaii
city: Chicago
country: United States
facility: Invivyd Investigative Site
state: Illinois
city: Oak Brook
country: United States
facility: Invivyd Investigative Site
state: Illinois
city: Owensboro
country: United States
facility: Invivyd Investigative Site
state: Kentucky
city: Marrero
country: United States
facility: Invivyd Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Invivyd Investigative Site
state: Louisiana
city: Rockville
country: United States
facility: Invivyd Investigative Site
state: Maryland
city: Burlington
country: United States
facility: Invivyd Investigative Site
state: Massachusetts
city: Caro
country: United States
facility: Invivyd Investigative Site
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Invivyd Investigative Site
state: Michigan
city: Missoula
country: United States
facility: Invivyd Investigative Site
state: Montana
city: Albuquerque
country: United States
facility: Invivyd Investigative Site
state: New Mexico
city: New York
country: United States
facility: Invivyd Investigative Site
state: New York
city: Charlotte
country: United States
facility: Invivyd Investigative Site
state: North Carolina
city: Shelby
country: United States
facility: Invivyd Investigative Site
state: North Carolina
city: Beachwood
country: United States
facility: Invivyd Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Invivyd Investigative Site
state: Ohio
city: Dresden
country: United States
facility: Invivyd Investigative Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Invivyd Investigative Site
state: Ohio
city: Yukon
country: United States
facility: Invivyd Investigative Site
state: Oklahoma
city: Medford
country: United States
facility: Invivyd Investigative Site
state: Oregon
city: West Columbia
country: United States
facility: Invivyd Investigative Site
state: South Carolina
city: Jackson
country: United States
facility: Invivyd Investigative Site
state: Tennessee
city: Milan
country: United States
facility: Invivyd Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Invivyd Investigative Site
state: Tennessee
city: Beaumont
country: United States
facility: Invivyd Investigative Site
state: Texas
city: College Station
country: United States
facility: Invivyd Investigative Site
state: Texas
city: Corpus Christi
country: United States
facility: Invivyd Investigative Site
state: Texas
city: Houston
country: United States
facility: Invivyd Investigative Site
state: Texas
city: Houston
country: United States
facility: Invivyd Investigative Site
state: Texas
city: Hurst
country: United States
facility: Invivyd Investigative Site
state: Texas
city: Mesquite
country: United States
facility: Invivyd Investigative Site
state: Texas
city: Sugar Land
country: United States
facility: Invivyd Investigative Site
state: Texas
city: Saint George
country: United States
facility: Invivyd Investigative Site
state: Utah
city: West Jordan
country: United States
facility: Invivyd Investigative Site
state: Utah
city: Richmond
country: United States
facility: Invivyd Investigative Site
state: Virginia
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Invivyd Investigative Site
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Invivyd Investigative Site
state: Buenos Aires
city: Munro
country: Argentina
facility: Invivyd Investigative Site
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: Invivyd Investigative Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Invivyd Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Invivyd Investigative Site
state: Sante Fe
city: Ostrava
country: Czechia
facility: Invivyd Investigative Site
city: Praha
country: Czechia
facility: Invivyd Investigative Site
city: Rychnov Nad Kněžnou
country: Czechia
facility: Invivyd Investigative Site
city: Batumi
country: Georgia
facility: Invivyd Investigative Site
city: Kutaisi
country: Georgia
facility: Invivyd Investigative Site
city: Rust'avi
country: Georgia
facility: Invivyd Investigative Site
city: Tbilisi
country: Georgia
facility: Invivyd Investigative Site
city: Tbilisi
country: Georgia
facility: Invivyd Investigative Site
city: Tbilisi
country: Georgia
facility: Invivyd Investigative Site
city: Tbilisi
country: Georgia
facility: Invivyd Investigative Site
city: Berlin
country: Germany
facility: Invivyd Investigative Site
city: Chisinau
country: Moldova, Republic of
facility: Invivyd Investigative Site
city: Kajetany
country: Poland
facility: Invivyd Investigative Site
city: Lublin
country: Poland
facility: Invivyd Investigative Site
city: Siedlce
country: Poland
facility: Invivyd Investigative Site
city: Skierniewice
country: Poland
facility: Invivyd Investigative Site
city: Warszawa
country: Poland
facility: Invivyd Investigative Site
city: Zamość
country: Poland
facility: Invivyd Investigative Site
city: Łódź
country: Poland
facility: Invivyd Investigative Site
city: Świdnica
country: Poland
facility: Invivyd Investigative Site
city: Bucuresti
country: Romania
facility: Invivyd Investigative Site
city: Kyiv
country: Ukraine
facility: Adagio Investigative Site
city: Kyiv
country: Ukraine
facility: Invivyd Investigative Site
Study officials:
References:
citation: 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.
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.