Evaluation of ADG20 for the Prevention of COVID-19

COVID-19 Clinical Trial

— EVADE  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04859517
• Other study ID #: ADG20-PREV-001
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: April 27, 2021
• Est. completion date: November 4, 2022

Study information

• Verified date: November 2022
• Source: Invivyd, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a 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 will be 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 will enrich for participants whose advanced age (≥55 years old) or health status places them at risk for severe COVID-19 or COVID-19 complications.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5951
• Est. completion date: November 4, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• ADG20
Single dose of ADG20
• Placebo
Single dose of placebo

Locations

Country	Name	City	State
Argentina	Invivyd Investigative Site	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Invivyd Investigative Site	Mar Del Plata	Buenos Aires
Argentina	Invivyd Investigative Site	Munro	Buenos Aires
Argentina	Invivyd Investigative Site	Ramos Mejía	Buenos Aires
Argentina	Invivyd Investigative Site	Rosario	Santa Fe
Argentina	Invivyd Investigative Site	Rosario	Sante Fe
Czechia	Invivyd Investigative Site	Ostrava
Czechia	Invivyd Investigative Site	Praha
Czechia	Invivyd Investigative Site	Rychnov Nad Knežnou
Georgia	Invivyd Investigative Site	Batumi
Georgia	Invivyd Investigative Site	Kutaisi
Georgia	Invivyd Investigative Site	Rust'avi
Georgia	Invivyd Investigative Site	Tbilisi
Georgia	Invivyd Investigative Site	Tbilisi
Georgia	Invivyd Investigative Site	Tbilisi
Georgia	Invivyd Investigative Site	Tbilisi
Germany	Invivyd Investigative Site	Berlin
Moldova, Republic of	Invivyd Investigative Site	Chisinau
Poland	Invivyd Investigative Site	Kajetany
Poland	Invivyd Investigative Site	Lódz
Poland	Invivyd Investigative Site	Lublin
Poland	Invivyd Investigative Site	Siedlce
Poland	Invivyd Investigative Site	Skierniewice
Poland	Invivyd Investigative Site	Swidnica
Poland	Invivyd Investigative Site	Warszawa
Poland	Invivyd Investigative Site	Zamosc
Romania	Invivyd Investigative Site	Bucuresti
Ukraine	Adagio Investigative Site	Kyiv
Ukraine	Invivyd Investigative Site	Kyiv
United States	Invivyd Investigative Site	Albuquerque	New Mexico
United States	Invivyd Investigative Site	Banning	California
United States	Invivyd Investigative Site	Beachwood	Ohio
United States	Invivyd Investigative Site	Beaumont	Texas
United States	Invivyd Investigative Site	Birmingham	Alabama
United States	Invivyd Investigative Site	Burlington	Massachusetts
United States	Invivyd Investigative Site	Caro	Michigan
United States	Invivyd Investigative Site	Charlotte	North Carolina
United States	Invivyd Investigative Site	Chicago	Illinois
United States	Invivyd Investigative Site	Chula Vista	California
United States	Invivyd Investigative Site	Cincinnati	Ohio
United States	Invivyd Investigative Site	Clearwater	Florida
United States	Invivyd Investigative Site	College Station	Texas
United States	Invivyd Investigative Site	Corpus Christi	Texas
United States	Invivyd Investigative Site	Culver City	California
United States	Invivyd Investigative Site	Dresden	Ohio
United States	Invivyd Investigative Site	Edgewater	Florida
United States	Invivyd Investigative Site	Escondido	California
United States	Invivyd Investigative Site	Fayetteville	Arkansas
United States	Invivyd Investigative Site	Fullerton	California
United States	Invivyd Investigative Site	Grosse Pointe Woods	Michigan
United States	Invivyd Investigative Site	Hialeah	Florida
United States	Invivyd Investigative Site	Hinesville	Georgia
United States	Invivyd Investigative Site	Houston	Texas
United States	Invivyd Investigative Site	Houston	Texas
United States	Invivyd Investigative Site	Hurst	Texas
United States	Invivyd Investigative Site	Jackson	Tennessee
United States	Invivyd Investigative Site	Lawrenceville	Georgia
United States	Invivyd Investigative Site	Long Beach	California
United States	Invivyd Investigative Site	Los Angeles	California
United States	Invivyd Investigative Site	Marrero	Louisiana
United States	Invivyd Investigative Site	Medford	Oregon
United States	Invivyd Investigative Site	Mesquite	Texas
United States	Invivyd Investigative Site	Miami	Florida
United States	Invivyd Investigative Site	Miami	Florida
United States	Invivyd Investigative Site	Miami	Florida
United States	Invivyd Investigative Site	Middleburg Heights	Ohio
United States	Invivyd Investigative Site	Milan	Tennessee
United States	Invivyd Investigative Site	Missoula	Montana
United States	Invivyd Investigative Site	Modesto	California
United States	Invivyd Investigative Site	Mount Dora	Florida
United States	Invivyd Investigative Site	Nashville	Tennessee
United States	Invivyd Investigative Site	New Orleans	Louisiana
United States	Invivyd Investigative Site	New York	New York
United States	Invivyd Investigative Site	North Little Rock	Arkansas
United States	Invivyd Investigative Site	North Miami Beach	Florida
United States	Invivyd Investigative Site	Oak Brook	Illinois
United States	Invivyd Investigative Site	Ormond Beach	Florida
United States	Invivyd Investigative Site	Owensboro	Kentucky
United States	Invivyd Investigative Site	Palm Springs	California
United States	Invivyd Investigative Site	Pearl City	Hawaii
United States	Invivyd Investigative Site	Pembroke Pines	Florida
United States	Invivyd Investigative Site	Richmond	Virginia
United States	Invivyd Investigative Site	Rockville	Maryland
United States	Invivyd Investigative Site	Saint George	Utah
United States	Invivyd Investigative Site	San Diego	California
United States	Invivyd Investigative Site	Shelby	North Carolina
United States	Invivyd Investigative Site	Sugar Land	Texas
United States	Invivyd Investigative Site	Sunrise	Florida
United States	Invivyd Investigative Site	Tampa	Florida
United States	Invivyd Investigative Site	The Villages	Florida
United States	Invivyd Investigative Site	Tucson	Arizona
United States	Invivyd Investigative Site	West Columbia	South Carolina
United States	Invivyd Investigative Site	West Jordan	Utah
United States	Invivyd Investigative Site	West Palm Beach	Florida
United States	Invivyd Investigative Site	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Invivyd, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Czechia,  Georgia,  Germany,  Moldova, Republic of,  Poland,  Romania,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with RT-PCR confirmed symptomatic COVID-19	Post-exposure prophylaxis (PEP) population	Through Day 28
Primary	Proportion of participants with RT-PCR confirmed symptomatic COVID-19	Pre-exposure prophylaxis (PrEP) population	Through 3 months
Primary	Incidence of solicited injection site reactions	PEP and PrEP populations	Through Day 4
Primary	Incidence of treatment emergent adverse events	PEP and PrEP populations	Through 14 months
Secondary	Proportion of participants with RT-PCR confirmed symptomatic COVID-19	PEP population	Through 3 months
Secondary	Proportion of participants with SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology	PEP and PrEP populations.	Through Day 28 (PEP only) and 3 months (PrEP)
Secondary	Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by RT-PCR	PEP population	On Days 8 and 15 after randomization
Secondary	Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by serology	PEP and PrEP populations	On Day 28 (PEP) and 6 months (PrEP)
Secondary	Peak post-baseline SARS-CoV-2 viral load as measured by RT-qPCR in participants with asymptomatic SARS-CoV-2 infection detected by qRT-PCR at baseline via surveillance	PEP population	Through Day 15
Secondary	SARS-CoV-2 viral load as assessed by RT-qPCR change from baseline in asymptomatic participants	PEP population	Through Day 15
Secondary	Proportion of participants with RT-PCR confirmed mild, moderate, or severe/critical COVID-19	PEP and PrEP populations	Through COVID-19-like illness Day 28
Secondary	Time to sustained resolution of COVID-19 symptoms	PEP and PrEP populations	Through COVID-19-like illness Day 28
Secondary	Proportion of participants with at least 1 COVID-19 related medically attended outpatient visit	PEP and PrEP populations	Through COVID-19-like illness Day 28
Secondary	Proportion of participants with a COVID-19 related hospitalization	PEP and PrEP populations	Through COVID-19-like illness Day 28
Secondary	Incidence of COVID-19 related mortality	PEP and PrEP populations	Through COVID-19-like illness Day 28
Secondary	Incidence of all cause mortality	PEP and PrEP populations	Through COVID-19-like illness Day 28
Secondary	Viral load as assessed by RT-qPCR in participants with COVID-19-like illness	PEP and PrEP populations	CLI Day 1 sample
Secondary	Assessment of PK Parameter: Cmax for ADG20	PEP and PrEP populations	12 months
Secondary	Assessment of PK Parameter: Area under the curve for ADG20	PEP and PrEP populations	12 months
Secondary	Assessment of PK Parameter: Half-life of ADG20	PEP and PrEP populations	12 months
Secondary	Assessment of PK Parameter: Clearance of ADG20	PEP and PrEP populations	12 months
Secondary	Assessment of PK Parameter: volume of distribution of ADG20	PEP and PrEP populations	12 months
Secondary	Incidence of ADA to ADG20	PEP and PrEP populations	12 months
Secondary	Time from randomization to first RT-PCR-confirmed symptomatic COVID-19	PEP and PrEP populations	Through Day 28 (PEP); through 3 months
Secondary	Time from randomization to first SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology	PEP and PrEP populations	Through Day 28 (PEP); through 3 months
Secondary	Probability of RT-PCR-confirmed symptomatic COVID-19	PEP and PrEP populations	Through Day 28 (PEP); through 3 months
Secondary	Probability of SARS-CoV-2 infection (asymptomatic or symptomatic) as determined by positive RT-PCR or serology	PEP and PrEP populations	Through Day 28 (PEP); through 3 months