| Primary | Incidence of COVID-19 Related Hospitalizations or All-cause Death | To evaluate the efficacy of ADG20 compared to placebo in the treatment of mild or moderate COVID-19 in participants at high risk of disease progression. Hospitalization is defined as ≥24 hours of acute care in a hospital or acute care facility (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities). All-cause death is defined as death for any reason from Day 1 (postdose) through Day 29. | Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants. | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Regression, Logistic | | 0.0047 | | Risk Difference (RD) | -8.7 | | | 2-Sided | 95 | -14.71 | -2.67 | | | | | Superiority | | A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method. |
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| Primary | Incidence of Treatment-emergent Adverse Events | Proportion of participants with at least one treatment emergent AE | Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received. Participants with more than one AE were only counted once. | Posted | | Count of Participants | | Participants | | Through day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Primary | Incidence of Solicited Injection Site Reactions | Proportion of participants with at least one solicited injection site reaction | Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received. | Posted | | Count of Participants | | Participants | | Through Day 4 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Primary | Changes From Baseline in Clinical Laboratory Tests (ie, CBC With Differential, Serum Chemistry, Coagulation) | Proportion of participants with a potentially clinically significant change from baseline in post-baseline laboratory parameters - data presented for any analyte with >/= 2% in any arm | Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received. | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Primary | Changes From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure) | Participants with Potentially Clinically Significant Changes (PCS) From Baseline in Vital Signs (Body Temperature, Heart Rate, Respiration Rate, and Systolic and Diastolic Blood Pressure) at Any Time Post-Baseline | Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received. | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Incidence of COVID-19 -Related Medically Attended Visits or All-cause Death | Proportion of participants with COVID-19-related medically attended visit (telemedicine, physician office, urgent care center, emergency room, hospitalization) or all-cause death through Day 29. In addition to events defined as the primary efficacy endpoint, this endpoint also includes any medically attended visits, in-person, or telemedicine, not specified in the protocol. These include unscheduled in-person or telemedicine visits conducted by the investigator for the purpose of evaluating worsening signs or symptoms attributed to COVID-19 or emergency room, urgent care center or physician office visits, or hospitalization for attention to worsening signs or symptoms attributed to COVID-19, in the opinion of the investigator. Incidence of COVID-19-related medically attended visits or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame. | Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants. | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Incidence of COVID-19 -Related Emergency Room Visits, COVID-19-related Hospitalization, or All Cause-death | Proportion of participants with any COVID 19-related emergency room visits, COVID-19-related hospitalization, or all cause death through Day 29. Defined as any stay in a hospital or acute care facility regardless of duration (includes emergency rooms, intensive care units, acute care facilities created for COVID-19 pandemic hospitalization needs, or other acute care facilities) for attention to worsening signs or symptoms attributed to COVID-19 in the opinion of the investigator or all cause death through Day 29. Incidence of COVID-19-related emergency room visits, COVID-19-related hospitalization, or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame. | Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to WGS-confirmed or suspected non-Omicron SARS-CoV-2 variants. | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Incidence of Severe/Critical COVID-19 or All Cause Death | Proportion of participants with Severe/Critical COVID-19 or all-cause death through Day 29. All-cause death is defined as death for any reason (from Day 1postdose) through Day 29. Severity is based on the investigator's assessment of severity (eCRF COVID-19 Severity Assessment) per the protocol definitions. Incidence of Severe/Critical COVID-19 or all-cause death includes participants who met any event defined for this endpoint. Participants were counted only once even if multiple events were met in the time frame. | Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants. | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Time to Sustained Recovery Defined as Sustained Improvement or Resolution of COVID-19 Symptoms | Time to sustained recovery (improvement or resolution) of COVID-19 symptoms through Day 29: Defined as the time from the first dose date to the earliest date when sustained improvement or sustained resolution of COVID-19 symptoms is met (as detailed below) through Day 29. COVID-19 symptoms assessed include fever, chills, cough, sore throat, congestion, shortness of breath/difficulty breathing at rest, shortness of breath/difficulty breathing with exertion, muscle or body aches, fatigue, headache, nausea, vomiting, and diarrhea. Loss of taste/smell is excluded from this analysis. | Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants. | Posted | | Median | 95% Confidence Interval | Days | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Incidence of All-cause Mortality | Defined as death for any reason from Day 1 (postdose). In the overall survival analysis, participants who are alive or lost to follow-up at the time of analysis are censored at the date of last contact. | Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants. | Posted | | Count of Participants | | Participants | | Through Day 90 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Time to Sustained Resolution of COVID-19 Symptoms as Measured in the Daily COVID-19 Symptom Diary | Time to sustained resolution of COVID-19 symptoms through Day 29: Defined as time from the dose date to the first date when all of the defined symptoms are scored as absent with no symptom recurrence or new symptoms, except cough, fatigue, and headache which may be mild or absent, through Day 29. | Modified Full Analysis Set (mFAS-non-Omicron): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants. | Posted | | Median | 95% Confidence Interval | Days | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL) to Day 7 (±1) | Assessed by RT qPCR From NP (Nasopharyngeal) Samples | Modified Full Analysis Set (mFAS-non-Omicron-NP): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline NP sample. | Posted | | Least Squares Mean | Standard Error | log10 copies/mL | | Day 7 (±1) | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Duration of SARS-CoV-2 Shedding Assessed by RT-qPCR From Saliva Samples | Duration of SARS-CoV-2 viral shedding is defined as time from the dose date to the first date the viral load is not detected, ie, below the limit of detection (LOD), and sustained through Day 29. Participants who do not have the defined event or who discontinue study prior to Day 29 are censored at the earlier date of the last viral load assessment or Day 30. Deaths occurring prior to Day 29 were censored at Day 30. | Modified Full Analysis Set (mFAS-non-Omicron-S): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline saliva sample. | Posted | | Median | 95% Confidence Interval | Days | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Viral Load >5 (log10 Copies/mL) Based on Nasopharyngeal Sampling at Day 7 | Proportion of participants with Viral load >5 (log10 copies/mL) on Day 7 assessed by RT-qPCR from NP sample. | Modified Full Analysis Set (mFAS-non-Omicron-NP): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline NP sample. | Posted | | Count of Participants | | Participants | | on Day 7 (+/- 1 Day) | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | SARS-CoV-2 Viral Clearance (Days 5, 7, 11, 14, 21, and 29) Assessed by RT-qPCR From Saliva Samples (and NP Samples for Day 7) | Proportions of SARS-CoV-2 viral clearance (Days 3, 5, 7, 11, 14, 21, and 29) assessed by RT-qPCR from saliva samples: In the mFAS-S, the cumulative proportion of participants with viral clearance (viral load not detected and sustained through Day 29) at Days 3, 5, 7, 11, 14, 21, and 29 will be assessed by RT-qPCR from saliva samples. Participants who have died or discontinued study prior to Day 29 are assumed to have no viral clearance. | Modified Full Analysis Set (mFAS-non-Omicron-S): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline saliva sample. | Posted | | Count of Participants | | Participants | | Days 5, 7, 11, 14, 21, and 29 (saliva) | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | SARS-CoV-2 Viral Load AUC Assessed by RT-qPCR From Saliva Samples | The AUC from Day 1 through Day 29 was calculated according to the linear trapezoidal rule using the measured SARS-CoV-2 viral load above the lower limit of quantification. No AUC values will be calculated when Day 1 and/or Day 29 values are missing, or if there are more than 3 values missing in the profile. | Modified Full Analysis Set (mFAS-non-Omicron-S): All randomized participants with COVID-19 due to Whole Genome Sequencing (WGS)-confirmed or suspected non-Omicron SARS-CoV-2 variants with a positive baseline saliva sample. | Posted | | Mean | Standard Deviation | log10 copies*day/mL | | Baseline to Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Incidence of Treatment Emergent Adverse Events | An AE is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to the study drug. AEs occurring from when the participant signed the ICF until the Month 14 (EOS) visit or discontinuation from study was recorded | Percent of participants who reported at least one TEAE. | Posted | | Count of Participants | | Participants | | 14 months | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Clinical Laboratory Test (PCS Defined Per Statistical Analysis Plan) | A PCS value is defined as any DAIDS grade 4 post-baseline or any increase of 2 or more DAIDS grades post-baseline, except for PCS low creatinine clearance, which is defined as any DAIDS Grade 4 post-baseline or any DAIDS grade shift from 0 to 3. Laboratory parameters not graded by DAIDs will be defined as PCS based on the criteria in the SAP (Appendix K.) | Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received. Data presented for any analyte with >/= 2% in any arm. | Posted | | Count of Participants | | Participants | | 14 Months | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan) | | Safety Set: All participants who received any amount of study drug. Participants were analyzed based on the actual treatment (ADG20 versus Placebo) received. | Posted | | Number | | participants | | 14 Months | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Incidence of ADA to ADG20 | | All participants in the Safety Set who had a valid immunogenicity test result before the dose of study drug, and at least 1 valid result after the dose of study drug; analysis limited to participants who received ADG20 only. | Posted | | Count of Participants | | Participants | | 11 months | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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| Secondary | Genotypic Characterization of Viral Isolates for Reduced Susceptibility to ADG20 (G504 Mutations) | Post-baseline Treatment-emergent Variations at Amino Acid Positions Associated with Reduced Susceptibility to ADG20 (>/= 15% Allele frequency); data limited to mutations observed. | Participants with any mutation at a monitored position >/= 15% allele frequency, in the population that had a qualifying (passed QC testing) baseline and post-baseline Whole Genome Sequencing sample. | Posted | | Count of Participants | | Participants | | Through Day 29 | | | | ID | Title | Description |
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| OG000 | ADG20 IM | Participants will be dosed on Day 1 with ADG20 IM ADG20: Single dose of ADG20 | | OG001 | Placebo IM | Participants will be dosed on Day 1 with placebo IM Normal saline: Single dose of normal saline |
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