COVID-19
Conditions
Keywords
Adintrevimab, ADG20, COVID-19, prevention, prophylaxis
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.
Interventions
DRUGADG20
Single dose of ADG20
DRUGPlacebo
Single dose of placebo
Sponsors
Invivyd, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The investigator, participant and sponsor personnel involved in study intervention and study evaluation will remain blinded to each participant's assigned study treatment throughout the course of the study.
Intervention model description
Randomized, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Solicited Injection Site Reactions (PEP, PrEP) | Day 1 through Day 4 | Percentage of participants with at least one solicited injection site reaction |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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 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 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. |
| 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 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) | — |
| 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. |
| 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) | — |
| 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 |
| 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 |
| 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. |
| COVID-19 Related Mortality (PrEP) | Through 28 Days from COVID-19-like illness initial visit (CLI Day 1) | — |
| 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 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 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) |
Countries
Argentina, Czechia, Georgia, Germany, Moldova, Poland, Romania, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADG20 IM - Cohort A ADG20 IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1. | 245 |
| Placebo IM - Cohort A Placebo IM - Cohort A is a post-exposure prophylaxis (PEP) arm where participants with no known history of SARS-CoV-2 infection and reported recent exposure (within 5 days) to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1. | 242 |
| ADG20 IM - Cohort B ADG20 IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of ADG20 IM on Day 1. | 1,048 |
| Placebo IM - Cohort B Placebo IM - Cohort B is a pre-exposure prophylaxis (PrEP) arm where participants with no known history of SARS-CoV-2 infection and no known recent exposure to SARS-CoV-2 but whose circumstances put them at increased risk of exposure to SARS-CoV-2 were dosed with a single dose of placebo IM on Day 1. | 1,047 |
| Total | 2,582 |
Baseline characteristics
| Characteristic | ADG20 IM - Cohort A | Placebo IM - Cohort A | ADG20 IM - Cohort B | Placebo IM - Cohort B | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 2 Participants | 7 Participants | 2 Participants | 16 Participants |
| Age, Categorical >=65 years | 31 Participants | 20 Participants | 99 Participants | 122 Participants | 272 Participants |
| Age, Categorical Between 18 and 65 years | 209 Participants | 220 Participants | 942 Participants | 923 Participants | 2294 Participants |
| Age, Continuous | 45.4 years STANDARD_DEVIATION 15.61 | 45.4 years STANDARD_DEVIATION 14.52 | 46.5 years STANDARD_DEVIATION 13.9 | 47.1 years STANDARD_DEVIATION 14.1 | 46.8 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 146 Participants | 143 Participants | 217 Participants | 248 Participants | 754 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 99 Participants | 785 Participants | 751 Participants | 1734 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 46 Participants | 48 Participants | 94 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 5 Participants | 12 Participants | 17 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 30 Participants | 168 Participants | 182 Participants | 409 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 15 Participants | 11 Participants | 27 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 6 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 23 Participants | 25 Participants | 50 Participants |
| Race (NIH/OMB) White | 214 Participants | 210 Participants | 821 Participants | 803 Participants | 2048 Participants |
| Region of Enrollment Argentina | 0 participants | 1 participants | 6 participants | 7 participants | 14 participants |
| Region of Enrollment Czechia | 0 participants | 0 participants | 3 participants | 5 participants | 8 participants |
| Region of Enrollment Georgia | 0 participants | 0 participants | 65 participants | 68 participants | 133 participants |
| Region of Enrollment Moldova | 0 participants | 0 participants | 5 participants | 2 participants | 7 participants |
| Region of Enrollment Poland | 0 participants | 0 participants | 17 participants | 16 participants | 33 participants |
| Region of Enrollment Romania | 43 participants | 36 participants | 0 participants | 0 participants | 79 participants |
| Region of Enrollment Ukraine | 22 participants | 25 participants | 82 participants | 81 participants | 210 participants |
| Region of Enrollment United States | 180 participants | 180 participants | 870 participants | 868 participants | 2098 participants |
| Sex: Female, Male Female | 123 Participants | 120 Participants | 508 Participants | 522 Participants | 1273 Participants |
| Sex: Female, Male Male | 122 Participants | 122 Participants | 540 Participants | 525 Participants | 1309 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 240 | 2 / 241 | 3 / 1,001 | 6 / 1,001 |
| other Total, other adverse events | 0 / 240 | 0 / 241 | 126 / 1,001 | 123 / 1,001 |
| serious Total, serious adverse events | 4 / 240 | 8 / 241 | 46 / 1,001 | 46 / 1,001 |
Outcome results
Primary
Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)
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
Time frame: Day 1 through 14 Months or 25Jul2022, whichever is earlier
Population: Participants who received any amount of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP) | 42 Participants |
| Placebo IM - Cohort A | Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP) | 51 Participants |
| ADG20 IM - Cohort B | Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP) | 399 Participants |
| Placebo IM - Cohort B | Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP) | 362 Participants |
Primary
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)
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.
Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) | 3 Participants |
| Placebo IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) | 12 Participants |
p-value: 0.012395% CI: [-8.87, -1.08]Regression, Logistic
Primary
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)
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.
Time frame: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP) | 12 Participants |
| Placebo IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP) | 40 Participants |
p-value: <0.000195% CI: [-5.75, -2.01]Regression, Logistic
Primary
Solicited Injection Site Reactions (PEP, PrEP)
Percentage of participants with at least one solicited injection site reaction
Time frame: Day 1 through Day 4
Population: Participants who received any amount of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Solicited Injection Site Reactions (PEP, PrEP) | 12 Participants |
| Placebo IM - Cohort A | Solicited Injection Site Reactions (PEP, PrEP) | 7 Participants |
| ADG20 IM - Cohort B | Solicited Injection Site Reactions (PEP, PrEP) | 75 Participants |
| Placebo IM - Cohort B | Solicited Injection Site Reactions (PEP, PrEP) | 73 Participants |
Secondary
All-Cause Mortality (PEP)
Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Day 28 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | All-Cause Mortality (PEP) | 0 Participants |
| Placebo IM - Cohort A | All-Cause Mortality (PEP) | 0 Participants |
Secondary
All-Cause Mortality (PrEP)
Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Month 3 in the pre-Omicron modified Full Analysis Set (mFAS): PrEP participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | All-Cause Mortality (PrEP) | 0 Participants |
| Placebo IM - Cohort A | All-Cause Mortality (PrEP) | 1 Participants |
Secondary
Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP)
PK samples collected at protocol-defined timepoints
Time frame: Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier
Population: Participants who received study drug and have measurable ADG20 concentration data for at least 2 post-injection time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADG20 IM - Cohort A | Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP) | Day 8 | 36.3 ug/mL | Standard Deviation 15.4 |
| ADG20 IM - Cohort A | Assessment of PK Parameter: ADG20 Plasma Concentrations (PEP) | Day 28 | 33.6 ug/mL | Standard Deviation 12.6 |
Secondary
Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP)
PK samples collected at protocol-defined timepoints
Time frame: Day 1 through 12 Months or end of study (11-Jan-2022), whichever is earlier
Population: Participants who received study drug and have measurable ADG20 concentration data for at least 2 post-injection time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADG20 IM - Cohort A | Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP) | Day 8 | 38.2 ug/mL | Standard Deviation 14.7 |
| ADG20 IM - Cohort A | Assessment of PK Parameter: ADG20 Plasma Concentrations (PrEP) | Day 28 | 33.6 ug/mL | Standard Deviation 12.5 |
Secondary
COVID-19 Related Mortality (PEP)
Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Population: Participants with RT- PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | COVID-19 Related Mortality (PEP) | 0 Participants |
| Placebo IM - Cohort A | COVID-19 Related Mortality (PEP) | 0 Participants |
Secondary
COVID-19 Related Mortality (PrEP)
Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Month 3 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | COVID-19 Related Mortality (PrEP) | 0 Participants |
| Placebo IM - Cohort A | COVID-19 Related Mortality (PrEP) | 1 Participants |
Secondary
Percentage of Participants With a COVID-19 Related Hospitalization (PEP)
Time frame: Through 28 Days from COVID-19-like illness initial visit (CLI Day 1)
Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Day 28 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With a COVID-19 Related Hospitalization (PEP) | 0 Participants |
| Placebo IM - Cohort A | Percentage of Participants With a COVID-19 Related Hospitalization (PEP) | 3 Participants |
Secondary
Percentage of Participants With a COVID-19 Related Hospitalization (PrEP)
Time frame: Through 28 days from COVID-19-like illness initial visit (CLI Day 1)
Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Month 3 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With a COVID-19 Related Hospitalization (PrEP) | 1 Participants |
| Placebo IM - Cohort A | Percentage of Participants With a COVID-19 Related Hospitalization (PrEP) | 6 Participants |
Secondary
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP)
Defined as having a central RT-qPCR-confirmed SARS-CoV-2 infection without having an RT-PCR-confirmed symptomatic COVID-19 outcome
Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP) | 3 Participants |
| Placebo IM - Cohort A | Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP) | 1 Participants |
Secondary
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP)
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)
Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP) | 0 Participants |
| Placebo IM - Cohort A | Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP) | 1 Participants |
Secondary
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP)
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)
Time frame: Day 1 through 6 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP) | 10 Participants |
| Placebo IM - Cohort A | Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP) | 18 Participants |
Secondary
Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP)
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.
Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants with RT-PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP) | 0 Participants |
| Placebo IM - Cohort A | Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP) | 3 Participants |
Secondary
Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP)
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.
Time frame: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants with RT-PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP) | 1 Participants |
| Placebo IM - Cohort A | Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP) | 6 Participants |
Secondary
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)
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.
Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants with RT-PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP) | Cohort A (PEP) Mild | 3 Participants |
| ADG20 IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP) | Cohort A (PEP) Moderate | 0 Participants |
| ADG20 IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP) | Cohort A (PEP) Severe/Critical | 0 Participants |
| Placebo IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP) | Cohort A (PEP) Mild | 7 Participants |
| Placebo IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP) | Cohort A (PEP) Moderate | 2 Participants |
| Placebo IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP) | Cohort A (PEP) Severe/Critical | 3 Participants |
Secondary
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)
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.
Time frame: Day 1 through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants with RT-PCR confirmed symptomatic COVID-19 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP) | Cohort B (PrEP) Mild | 7 Participants |
| ADG20 IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP) | Cohort B (PrEP) Moderate | 4 Participants |
| ADG20 IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP) | Cohort B (PrEP) Severe/Critical | 1 Participants |
| Placebo IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP) | Cohort B (PrEP) Mild | 14 Participants |
| Placebo IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP) | Cohort B (PrEP) Moderate | 19 Participants |
| Placebo IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP) | Cohort B (PrEP) Severe/Critical | 7 Participants |
Secondary
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)
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.
Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) | 1 Participants |
| Placebo IM - Cohort A | Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) | 7 Participants |
p-value: 0.015395% CI: [-13.74, -1.46]Regression, Logistic
Secondary
Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP)
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.
Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADG20 IM - Cohort A | Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP) | 6 Participants |
| Placebo IM - Cohort A | Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP) | 14 Participants |
p-value: 0.061295% CI: [-9.03, 0.21]Regression, Logistic
Secondary
SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP)
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).
Time frame: Day 1 through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants with RT-qPCR-confirmed asymptomatic SARS-CoV-2 infection in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADG20 IM - Cohort A | SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP) | Day 8 | 2.96 Viral load (log10 copies/mL) | Standard Deviation 4.186 |
| ADG20 IM - Cohort A | SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP) | Day 15 | 2.15 Viral load (log10 copies/mL) | Standard Deviation 1.985 |
| Placebo IM - Cohort A | SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP) | Day 8 | 0 Viral load (log10 copies/mL) | Standard Deviation 0 |
| Placebo IM - Cohort A | SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP) | Day 15 | 3.16 Viral load (log10 copies/mL) | — |
Secondary
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP)
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 frame: An average of 2 months up to 7 months through cutoff date prior to emergence of Omicron (15-Dec-2021)
Population: Participants in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADG20 IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP) | Day 28 | 1.74 Percent probability |
| ADG20 IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP) | Day 60 | 1.74 Percent probability |
| ADG20 IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP) | Day 90 | 1.74 Percent probability |
| Placebo IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP) | Day 28 | 7.01 Percent probability |
| Placebo IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP) | Day 60 | 7.84 Percent probability |
| Placebo IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PEP) | Day 90 | 7.84 Percent probability |
p-value: 0.007795% CI: [0.06, 0.76]Log Rank
Secondary
Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP)
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 frame: An average of 2.5 months up to 7.5 months through cutoff date prior to emergence of Omicron (15-Dec-2021)
Population: Participants in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ADG20 IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP) | Day 28 | 0.96 Percent probability |
| ADG20 IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP) | Day 60 | 1.31 Percent probability |
| ADG20 IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP) | Day 90 | 2.01 Percent probability |
| Placebo IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP) | Day 28 | 2.32 Percent probability |
| Placebo IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP) | Day 60 | 5.64 Percent probability |
| Placebo IM - Cohort A | Time From Randomization to First RT-PCR-confirmed Symptomatic COVID-19 (PrEP) | Day 90 | 7.26 Percent probability |
p-value: <0.000195% CI: [0.14, 0.49]Log Rank
Secondary
Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PEP)
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).
Time frame: Positive CLI Day 1 sample through Day 28 or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Day 28 in the pre-Omicron modified Full Analysis Set-1 (mFAS-1): participants without current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative regardless of serostatus) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADG20 IM - Cohort A | Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PEP) | 2.43 log10 copies/mL | Standard Deviation 2.372 |
| Placebo IM - Cohort A | Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PEP) | 5.74 log10 copies/mL | Standard Deviation 2.689 |
Secondary
Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PrEP)
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).
Time frame: Positive CLI Day 1 sample through 3 Months or emergence of Omicron (15-Dec-2021), whichever is earlier
Population: Participants with RT-PCR confirmed symptomatic COVID-19 through Month 3 in the pre-Omicron modified Full Analysis Set (mFAS): participants without prior or current SARS-CoV-2 infection at baseline based on central tests (baseline RT-PCR-negative and seronegative) randomized on or prior to 30-Nov-2021, allowing participants to be followed a minimum of 2 weeks through 15-Dec-2021 when Omicron became the predominant variant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADG20 IM - Cohort A | Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PrEP) | 4.58 Log10 copies/mL | Standard Deviation 2.73 |
| Placebo IM - Cohort A | Viral Load as Assessed by RT-qPCR in Participants With Confirmed Symptomatic COVID-19 (PrEP) | 6.58 Log10 copies/mL | Standard Deviation 1.825 |