Evaluation of ADG20 for the Prevention of COVID-19

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

Detailed Description
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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.

Official Title
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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)

Conditions
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COVID-19

Intervention / Treatment
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* Drug: ADG20
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADG20<br>Participants will be dosed on Day 1 with ADG20 IM | Drug: ADG20<br>* Single dose of ADG20<br>|
| Placebo Comparator: Placebo<br>Participants will be dosed on Day 1 with placebo IM | Drug: Placebo<br>* Single dose of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with RT-PCR confirmed symptomatic COVID-19 | Post-exposure prophylaxis (PEP) population | Through Day 28 | 
| Proportion of participants with RT-PCR confirmed symptomatic COVID-19 | Pre-exposure prophylaxis (PrEP) population | Through 3 months | 
| Incidence of solicited injection site reactions | PEP and PrEP populations | Through Day 4 | 
| Incidence of treatment emergent adverse events | PEP and PrEP populations | Through 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with RT-PCR confirmed symptomatic COVID-19 | PEP population | Through 3 months | 
| 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) | 
| Proportion of participants with asymptomatic SARS-CoV-2 infection as determined by RT-PCR | PEP population | On Days 8 and 15 after randomization | 
| 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) | 
| 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 | 
| SARS-CoV-2 viral load as assessed by RT-qPCR change from baseline in asymptomatic participants | PEP population | Through Day 15 | 
| 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 | 
| Time to sustained resolution of COVID-19 symptoms | PEP and PrEP populations | Through COVID-19-like illness Day 28 | 
| 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 | 
| Proportion of participants with a COVID-19 related hospitalization | PEP and PrEP populations | Through COVID-19-like illness Day 28 | 
| Incidence of COVID-19 related mortality | PEP and PrEP populations | Through COVID-19-like illness Day 28 | 
| Incidence of all cause mortality | PEP and PrEP populations | Through COVID-19-like illness Day 28 | 
| Viral load as assessed by RT-qPCR in participants with COVID-19-like illness | PEP and PrEP populations | CLI Day 1 sample | 
| Assessment of PK Parameter: Cmax for ADG20 | PEP and PrEP populations | 12 months | 
| Assessment of PK Parameter: Area under the curve for ADG20 | PEP and PrEP populations | 12 months | 
| Assessment of PK Parameter: Half-life of ADG20 | PEP and PrEP populations | 12 months | 
| Assessment of PK Parameter: Clearance of ADG20 | PEP and PrEP populations | 12 months | 
| Assessment of PK Parameter: volume of distribution of ADG20 | PEP and PrEP populations | 12 months | 
| Incidence of ADA to ADG20 | PEP and PrEP populations | 12 months | 
| Time from randomization to first RT-PCR-confirmed symptomatic COVID-19 | PEP and PrEP populations | Through Day 28 (PEP); through 3 months | 
| 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 | 
| Probability of RT-PCR-confirmed symptomatic COVID-19 | PEP and PrEP populations | Through Day 28 (PEP); through 3 months | 
| 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 |