12 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)Primary· 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.
Group
Value
95% CI
ADG20 IM - Cohort A
3
Placebo IM - Cohort A
12
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PrEP)Primary· 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.
Group
Value
95% CI
ADG20 IM - Cohort B
12
Placebo IM - Cohort B
40
Solicited Injection Site Reactions (PEP, PrEP)Primary· Day 1 through Day 4
Percentage of participants with at least one solicited injection site reaction
Group
Value
95% CI
ADG20 IM - Cohort A
12
Placebo IM - Cohort A
7
ADG20 IM - Cohort B
75
Placebo IM - Cohort B
73
Participants With at Least 1 Treatment Emergent Adverse Events (PEP, PrEP)Primary· 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
Group
Value
95% CI
ADG20 IM - Cohort A
42
Placebo IM - Cohort A
51
ADG20 IM - Cohort B
399
Placebo IM - Cohort B
362
Percentage of Participants With RT-PCR Confirmed Symptomatic COVID-19 (PEP)Secondary· 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.
Group
Value
95% CI
ADG20 IM - Cohort A
1
Placebo IM - Cohort A
7
Percentage of Participants With SARS-CoV-2 Infection (Asymptomatic or Symptomatic) as Determined by Positive RT-PCR or Serology (PEP)Secondary· 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.
Group
Value
95% CI
ADG20 IM - Cohort A
6
Placebo IM - Cohort A
14
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by RT-PCR (PEP)Secondary· 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
Group
Value
95% CI
ADG20 IM - Cohort A
3
Placebo IM - Cohort A
1
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PEP)Secondary· 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)
Group
Value
95% CI
ADG20 IM - Cohort A
0
Placebo IM - Cohort A
1
Percentage of Participants With Asymptomatic SARS-CoV-2 Infection as Determined by Serology (PrEP)Secondary· 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)
Group
Value
95% CI
ADG20 IM - Cohort B
10
Placebo IM - Cohort B
18
SARS-CoV-2 Viral Load as Assessed by RT-qPCR Change From Baseline in Asymptomatic Participants (PEP)Secondary· 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).
Day 8
Group
Value
95% CI
ADG20 IM - Cohort A
2.96
± 4.186
Placebo IM - Cohort A
0
± 0
Day 15
Group
Value
95% CI
ADG20 IM - Cohort A
2.15
± 1.985
Placebo IM - Cohort A
3.16
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PEP)Secondary· 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.
Group
Value
95% CI
ADG20 IM - Cohort A
3
Placebo IM - Cohort A
7
ADG20 IM - Cohort A
0
Placebo IM - Cohort A
2
ADG20 IM - Cohort A
0
Placebo IM - Cohort A
3
Percentage of Participants With RT-PCR Confirmed Mild, Moderate, or Severe/Critical COVID-19 (PrEP)Secondary· 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.
Group
Value
95% CI
ADG20 IM - Cohort B
7
Placebo IM - Cohort B
14
ADG20 IM - Cohort B
4
Placebo IM - Cohort B
19
ADG20 IM - Cohort B
1
Placebo IM - Cohort B
7
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline through Month 14 or end of study (11-Jan-2022), whichever is earlier.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
ADG20 IM - Cohort A
Serious: 4/240 (2%)
Deaths: 0/240
Placebo IM - Cohort A
Serious: 8/241 (3%)
Deaths: 2/241
ADG20 IM - Cohort B
Serious: 46/1001 (5%)
Deaths: 3/1001
Placebo IM - Cohort B
Serious: 46/1001 (5%)
Deaths: 6/1001
Serious adverse events (87 terms)
Reaction
System
ADG20 IM - Cohort A
Placebo IM - Cohort A
ADG20 IM - Cohort B
Placebo IM - Cohort B
COVID-19 pneumonia
Infections and infestations
—
—
—
—
COVID-19
Infections and infestations
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
Hip fracture
Injury, poisoning and procedural complications
—
—
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NCT04805671 — Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
· Phase 2, PHASE3
· terminated
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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· Phase 1
· recruiting
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· Phase 2
· recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A
· Phase 3
· active not recruiting
Other Invivyd, Inc. trials
Trials by the same sponsor.
NCT06039449 — A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 1
· Phase 3
· completed
NCT05791318 — A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult
· Phase 1
· completed
NCT04805671 — Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19
· Phase 2, PHASE3
· terminated
NCT06004128 — Provide Pre-approval Single-patient Expanded Access (Compassionate Use) of VYD222 for Patients With Symptomatic COVID-19
· no longer available
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Invivyd, Inc.
Last refreshed: 20 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04859517.