Trial · NCT04859517
Evaluation of ADG20 for the Prevention of COVID-19
NCT04859517, Phase 2, Phase 3, Terminated, Invivyd, Inc.; results first posted 2024-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of ADG20 for the Prevention of COVID-19. Trials, record NCT04859517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04859517
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of ADG20 for the Prevention of COVID-19
- NCT number
- NCT04859517
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 2,582 participants, actual
- Lead sponsor
- Invivyd, Inc.
- Conditions
- COVID-19
- Interventions
- ADG20, Placebo
- First posted
- 2021-04-26
- Last updated
- 2024-08-20
- Results first posted
- 2024-08-20
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | Solicited Injection Site Reactions (PEP, PrEP) | Day 1 through Day 4 | Percentage of participants with at least one solicited injection site reaction |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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). |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Solicited Injection Site Reactions (PEP, PrEP) | Day 1 through Day 4 | Participants who received any amount of study drug | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP) | Day 1 through 14 Months or 25Jul2022, whichever is earlier | Participants who received any amount of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 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. | Viral load (log10 copies/mL) | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) | ADG20 IM - Cohort A | 3 | Participants | ||
| Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) | Placebo IM - Cohort A | 12 | Participants | ||
| Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP) | ADG20 IM - Cohort B | 12 | Participants | ||
| Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP) | Placebo IM - Cohort B | 40 | Participants | ||
| Solicited Injection Site Reactions (PEP, PrEP) | ADG20 IM - Cohort A | 12 | Participants | ||
| Solicited Injection Site Reactions (PEP, PrEP) | Placebo IM - Cohort A | 7 | Participants | ||
| Solicited Injection Site Reactions (PEP, PrEP) | ADG20 IM - Cohort B | 75 | Participants | ||
| Solicited Injection Site Reactions (PEP, PrEP) | Placebo IM - Cohort B | 73 | Participants | ||
| Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP) | ADG20 IM - Cohort A | 42 | Participants | ||
| Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP) | Placebo IM - Cohort A | 51 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ADG20 IM - Cohort A | 245 | |
| Overall Study | STARTED | Placebo IM - Cohort A | 242 | |
| Overall Study | STARTED | ADG20 IM - Cohort B | 1,048 | |
| Overall Study | STARTED | Placebo IM - Cohort B | 1,047 | |
| Overall Study | COMPLETED | ADG20 IM - Cohort A | 32 | |
| Overall Study | COMPLETED | Placebo IM - Cohort A | 35 | |
| Overall Study | COMPLETED | ADG20 IM - Cohort B | 226 | |
| Overall Study | COMPLETED | Placebo IM - Cohort B | 236 | |
| Overall Study | NOT COMPLETED | ADG20 IM - Cohort A | 213 | |
| Overall Study | NOT COMPLETED | Placebo IM - Cohort A | 207 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events356
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | ADG20 IM - Cohort A | 240 | ||
| other | Injection site pain | General disorders | Placebo IM - Cohort A | 241 | ||
| other | Injection site pain | General disorders | ADG20 IM - Cohort B | 76 | 1,001 | |
| other | Injection site pain | General disorders | Placebo IM - Cohort B | 84 | 1,001 | |
| other | Influenza like illness | General disorders | ADG20 IM - Cohort A | 240 | ||
| other | Influenza like illness | General disorders | Placebo IM - Cohort A | 241 | ||
| other | Influenza like illness | General disorders | ADG20 IM - Cohort B | 59 | 1,001 | |
| other | Influenza like illness | General disorders | Placebo IM - Cohort B | 46 | 1,001 | |
| serious | COVID-19 pneumonia | Infections and infestations | ADG20 IM - Cohort A | 1 | 240 | |
| serious | COVID-19 pneumonia | Infections and infestations | Placebo IM - Cohort A | 4 | 241 |
1 to 10 of 356Source ClinicalTrials.gov
See all 356 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ADG20 IM - Cohort A | 0 | 240 |
| Total, all-cause mortality | Placebo IM - Cohort A | 2 | 241 |
| Total, all-cause mortality | ADG20 IM - Cohort B | 3 | 1,001 |
| Total, all-cause mortality | Placebo IM - Cohort B | 6 | 1,001 |
| Total, other adverse events | ADG20 IM - Cohort A | 0 | 240 |
| Total, other adverse events | Placebo IM - Cohort A | 0 | 241 |
| Total, other adverse events | ADG20 IM - Cohort B | 126 | 1,001 |
| Total, other adverse events | Placebo IM - Cohort B | 123 | 1,001 |
| Total, serious adverse events | ADG20 IM - Cohort A | 4 | 240 |
| Total, serious adverse events | Placebo IM - Cohort A | 8 | 241 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons15
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ADG20 IM - Cohort B vs Placebo IM - Cohort B: Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PrEP) | Trial comparisons |
| ADG20 IM - Cohort B vs Placebo IM - Cohort B: Percentage of Participants With a COVID-19 Related Hospitalization (PrEP) | Trial comparisons |
| ADG20 IM - Cohort A vs Placebo IM - Cohort A: Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP) | Trial comparisons |
| ADG20 IM - Cohort A vs Placebo IM - Cohort A: All-Cause Mortality (PEP) | Trial comparisons |
| ADG20 IM - Cohort A vs Placebo IM - Cohort A: Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP) | Trial comparisons |
| ADG20 IM - Cohort B vs Placebo IM - Cohort B: All-Cause Mortality (PrEP) | Trial comparisons |
| ADG20 IM - Cohort A vs Placebo IM - Cohort A: Percentage of Participants With a COVID-19 Related Hospitalization (PEP) | Trial comparisons |
| ADG20 IM - Cohort A vs Placebo IM - Cohort A: Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP) | Trial comparisons |
| ADG20 IM - Cohort A vs Placebo IM - Cohort A: Percentage of Participants With at Least 1 COVID-19 Related Medically Attended Outpatient Visit (PEP) | Trial comparisons |
| ADG20 IM - Cohort B vs Placebo IM - Cohort B: COVID-19 Related Mortality (PrEP) | Trial comparisons |
1 to 10 of 15
See all 15 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT04859517/registered?page=2