Evaluation of ADG20 for the Prevention of COVID-19

Phase 3TerminatedNCT04859517

Invivyd, Inc.2,582 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

2,582

Conditions

COVID-19

Interventions

ADG20DRUG

Single dose of ADG20

PlaceboDRUG

Single dose of placebo

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (95)

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: 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

Time frame: 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

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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Invivyd Investigative Site

Birmingham, Alabama, United States

Invivyd Investigative Site

Tucson, Arizona, United States

Invivyd Investigative Site

Fayetteville, Arkansas, United States

Invivyd Investigative Site

North Little Rock, Arkansas, United States

Invivyd Investigative Site

Banning, California, United States

Invivyd Investigative Site

Chula Vista, California, United States

Invivyd Investigative Site

Culver City, California, United States

Invivyd Investigative Site

Escondido, California, United States

Invivyd Investigative Site

Fullerton, California, United States

Invivyd Investigative Site

Long Beach, California, United States

...and 85 more locations

RT-PCR-confirmed symptomatic COVID-19 is determined by a positive central or local (in the absence of central test) RT-PCRtest 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.

Time frame: 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)

Participants with RT-PCR-confirmed symptomatic COVID-19 (protocol defined COVID-19 symptoms occurring within 14 days from the sample collection date of a positive central or local \[in the absence of central test\] RT-PCR, any COVID-19-related hospitalization with a positive local SARS-CoV-2 test \[within 14 days\], or all-cause death), central RT-PCR-confirmed SARS-CoV-2 infection, or central serology-confirmed SARS-CoV-2 infection with negative central serology at baseline.

Time frame: 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)

Defined as having a central RT-qPCR-confirmed SARS-CoV-2 infection without having an RT-PCR-confirmed symptomatic COVID-19 outcome

Time frame: 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)

Defined as having a central serology-confirmed SARS-CoV-2 infection (with a negative central serology test sample at baseline) and without having an RT-PCR-confirmed symptomatic COVID-19 outcome (including COVID-19-related hospitalization and all-cause death)

Time frame: 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)

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

SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP)

Asymptomatic SARS-CoV-2 infection confirmed by RT-qPCR from nasal swab collected at Day 8 and Day 15. Viral load values reported as detected but below the lower quantification of the PCR assay (\< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as \> 7.1×10\^7 copies/mL are imputed with 7.1×10\^7 copies/mL (i.e., 7.85 log10 copies/mL).

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

Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)

Maximum severity assessed from COVID-19-like illness (CLI) Day 1 through CLI Day 28. COVID-19-related hospitalizations or COVID-19-related deaths from CLI Day 1 to CLI Day 28 are categorized as severe/critical.

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

Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)

Maximum severity assessed from COVID-19-like Illness (CLI) Day 1 through CLI Day 28. COVID-19-related hospitalizations or COVID-19-related deaths from CLI Day 1 to CLI Day 28 are categorized as severe/critical.

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

Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP)

Physician office, telemedicine, emergency room or urgent care center visits in participants with RT-PCR-confirmed symptomatic COVID-19 events, defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.

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

Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP)

Physician office, telemedicine, emergency room or urgent care center visits in participants with RT-PCR confirmed symptomatic COVID-19, defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.

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

Percentage of Participants With a COVID-19 Related Hospitalization (PEP)

Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)

Percentage of Participants With a COVID-19 Related Hospitalization (PrEP)

Time frame: Through 28 days from COVID-19-like illness initial visit (CLI Day 1)

COVID-19 Related Mortality (PEP)

Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)

COVID-19 Related Mortality (PrEP)

Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)

All-Cause Mortality (PEP)

Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)

All-Cause Mortality (PrEP)

Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)

Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PEP)

Viral load from COVID-19-like illness (CLI) Day 1 sample. Viral load values reported as detected but below the lower quantification of the PCR assay (\< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as \> 7.1×10\^7 copies/mL are imputed with 7.1×10\^7 copies/mL (i.e., 7.85 log10 copies/mL).

Time frame: Positive CLI Day 1 sample through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier

Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PrEP)

Viral load from COVID-19-like Illness (CLI) Day 1 sample. Viral load values reported as detected but below the lower quantification of the PCR assay (\< 714 copies/mL) are imputed with half the lower limit of quantification of the PCR assay (i.e., 357 copies/mL = 2.55 log10 copies/mL). Viral load values reported as \> 7.1×10\^7 copies/mL are imputed with 7.1×10\^7 copies/mL (i.e., 7.85 log10 copies/mL).

Time frame: Positive CLI Day 1 sample through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier

Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP)

PK samples collected at protocol-defined timepoints

Time frame: Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier

Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP)

PK samples collected at protocol-defined timepoints

Time frame: Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier

Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP)

Outcome measure is presented as cumulative probability expressed in percentage. RT-PCR-confirmed symptomatic COVID-19 event is defined as having a central RT-PCR-confirmed SARS-CoV-2 infection with COVID-19 symptoms occurring within 14 days from the positive RT-PCR test sample collection, COVID-19-related hospitalization with a positive local or central SARS-CoV-2 test within 14 days, or all-cause death.

Time frame: An average of 2 months up to 7 months through cutoff date prior to emergence of Omicron (15-Dec-2021)

Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP)

Time frame: An average of 2.5 months up to 7.5 months through cutoff date prior to emergence of Omicron (15-Dec-2021)