Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19

Study Overview
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Brief Summary
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This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.

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 Treatment of Ambulatory Participants With Mild or Moderate COVID-19 (STAMP)

Conditions
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COVID-19

Intervention / Treatment
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* Drug: ADG20
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization Has had symptoms consistent with COVID-19 with onset 5 days before randomization Has one or more COVID-19-related signs or symptoms on the day of randomization Phase 2: Is an adult aged 18 years and above Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening Exclusion Criteria: Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization. Has severe COVID-19 or is on supplemental oxygen Has a history of a positive SARS-CoV-2 antibody serology test Has participated, within the last 30 days, in a clinical study involving an investigational intervention Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID-19 any time prior to participation in the study 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: Treatment
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 IM<br>Participants will be dosed on Day 1 with ADG20 IM | Drug: ADG20<br>* Single dose of ADG20<br>|
| Placebo Comparator: Placebo IM<br>Participants will be dosed on Day 1 with placebo IM | Drug: Normal saline<br>* Single dose of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 related hospitalizations or all-cause death |  | Through Day 29 | 
| Incidence of treatment-emergent adverse events |  | Through day 29 | 
| Incidence of solicited injection site reactions |  | Through Day 4 | 
| Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation) |  | Through Day 29 | 
| Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure) |  | Through Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID-19 -related medically attended visits |  | Through Day 29 | 
| Incidence of COVID-19 -related emergency room visits, COVID-19-related hospitalization, or all cause-death |  | Through Day 29 | 
| Incidence of severe/critical COVID-19 or all cause death |  | Through Day 29 | 
| Time to sustained recovery defined as sustained improvement or resolution of COVID-19 symptoms |  | Through Day 29 | 
| Incidence of all-cause mortality |  | Through Day 29, Day 60 and Day 90 | 
| Time to sustained resolution of COVID-19 symptoms as measured in the Daily COVID-19 Symptom Diary |  | Through Day 29 | 
| Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) assessed by RT-qPCR from saliva samples (and NP samples for Day 7) |  | Days 3, 5, 7, 11 and 14 (saliva); Day 7 (NP swab) | 
| Duration of SARS-CoV-2 shedding assessed by RT-qPCR from saliva samples |  | Through Day 29 | 
| Viral load >5 (log10 copies/mL) based on nasopharyngeal sampling |  | on Day 7 (+/- 1) | 
| SARS-CoV-2 viral clearance assessed by RT-qPCR from saliva samples (and NP samples for Day 7) |  | Days 5, 7, 11, 14, 21, and 29 (saliva); Day 7 (NP swab) | 
| SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples |  | Baseline to Day 29 | 
| Incidence of treatment emergent adverse events |  | 14 months | 
| Number of participants with potentially clinically significant (PCS) changes from baseline in clinical laboratory test (PCS defined per statistical analysis plan) |  | 14 Months | 
| Number of participants with potentially clinically significant (PCS) changes from baseline in vital sign parameters (PCS defined per statistical analysis plan) |  | 14 Months | 
| Assessment of PK Parameter: Cmax for ADG20 |  | 11 Months | 
| Assessment of PK Parameter: Time to Cmax (Tmax) for ADG20 |  | 11 Months | 
| Assessment of PK Parameter: Area under the curve for ADG20 |  | 11 Months | 
| Assessment of PK Parameter: Clearance of ADG20 |  | 11 Months | 
| Assessment of PK Parameter: volume of distribution of ADG20 |  | 11 Months | 
| Assessment of PK Parameter: Half-life of ADG20 |  | 11 Months | 
| Incidence of ADA to ADG20 |  | 11 months | 
| Genotypic characterization of viral isolates for reduced susceptibility to ADG20 |  | Through Day 29 |