Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| 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. |
Through Day 29 |
|
| Primary |
Incidence of Treatment-emergent Adverse Events |
Proportion of participants with at least one treatment emergent AE |
Through day 29 |
|
| Primary |
Incidence of Solicited Injection Site Reactions |
Proportion of participants with at least one solicited injection site reaction |
Through Day 4 |
|
| 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 |
Through Day 29 |
|
| 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 |
Through Day 29 |
|
| 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. |
Through Day 29 |
|
| 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. |
Through Day 29 |
|
| 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. |
Through Day 29 |
|
| 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. |
Through Day 29 |
|
| 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. |
Through Day 90 |
|
| 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. |
Through Day 29 |
|
| 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 |
Day 7 (±1) |
|
| 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. |
Through Day 29 |
|
| 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. |
on Day 7 (+/- 1 Day) |
|
| 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. |
Days 5, 7, 11, 14, 21, and 29 (saliva) |
|
| 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. |
Baseline to Day 29 |
|
| 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 |
14 months |
|
| 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.) |
14 Months |
|
| Secondary |
Number of Participants With Potentially Clinically Significant (PCS) Changes From Baseline in Vital Sign Parameters (PCS Defined Per Statistical Analysis Plan) |
|
14 Months |
|
| Secondary |
Incidence of ADA to ADG20 |
|
11 months |
|
| 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. |
Through Day 29 |
|
