Evaluation of ADG20 for the Prevention of COVID-19

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Drug: ADG20; Drug: Placebo

• Registration Number: NCT04859517
• Lead Sponsor: Invivyd, Inc.

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.

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-26
• Study Start: 2021-04-27
• Primary Completion: 2022-11-04
• Study Completion: 2022-11-04
• Status Verified: 2024-04
• Results First Submitted: 2024-04-25
• Results First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Results First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2582

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADG20	ADG20	Participants will be dosed on Day 1 with ADG20 IM
Placebo	Placebo	Participants will be dosed on Day 1 with placebo IM

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)	Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier	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.
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	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.
Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)	Day 1 through 14 Months or 25Jul2022, whichever is earlier	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
Solicited Injection Site Reactions (PEP, PrEP)	Day 1 through Day 4	Percentage of participants with at least one solicited injection site reaction

Secondary Outcome Measures

Name	Time	Method
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	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.
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)	Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier	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.
Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP)	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier	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.
Percentage of Participants With a COVID-19 Related Hospitalization (PEP)	Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
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	Defined as having a central RT-qPCR-confirmed SARS-CoV-2 infection without having an RT-PCR-confirmed symptomatic COVID-19 outcome
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier	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.
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	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.
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	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)
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	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)
Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP)	Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier	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.
COVID-19 Related Mortality (PrEP)	Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
All-Cause Mortality (PEP)	Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
All-Cause Mortality (PrEP)	Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP)	Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier	PK samples collected at protocol-defined timepoints
SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP)	Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier	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).
Percentage of Participants With a COVID-19 Related Hospitalization (PrEP)	Through 28 days from COVID-19-like illness initial visit (CLI Day 1)
COVID-19 Related Mortality (PEP)	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)	Positive CLI Day 1 sample through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier	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).
Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PrEP)	Positive CLI Day 1 sample through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier	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).
Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP)	Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier	PK samples collected at protocol-defined timepoints
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP)	An average of 2 months up to 7 months through cutoff date prior to emergence of Omicron (15-Dec-2021)	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 From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP)	An average of 2.5 months up to 7.5 months through cutoff date prior to emergence of Omicron (15-Dec-2021)	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.

Trial Locations

Locations (2)

Invivyd Investigative Site; 🇺🇦 Kyiv, Ukraine

Adagio Investigative Site; 🇺🇦 Kyiv, Ukraine