COVID-19Phase 3NCT06039449

A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2

A Phase 3 study testing VYD222 (pemivibart) and Normal saline in people with COVID-19 and SARS-CoV-2, run by Invivyd, Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A study to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2 Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: COVID-19, SARS-CoV-2
What is being tested?: VYD222 (pemivibart) and Normal saline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 790 participants
Where: 18 sitesUnited States
Study dates: 8 Sep 2023to 19 Nov 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Is an adult aged ≥18 years or an adolescent aged 12 to <18 years and weighs at least 40 kg at the time of Screening.
Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at the time of Screening.
For Cohort A, has significant immune compromise from causes including solid tumor or hematologic malignancies, chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic stem cell transplant, primary immunodeficiency, advanced HIV infection, or receiving qualifying immunosuppressive therapies.
For Cohort B, is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings.
Agrees to defer receipt of any COVID-19 vaccination or booster for a minimum of 28 days after dosing.
Note: unless specified by Cohort, the criteria apply to both Cohorts

Who cannot join

For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before randomization.
Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization.
Prior known or suspected SARS-CoV-2 infection within 120 days before randomization.
Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before randomization.
Is acutely ill or has any symptoms suggestive of infection, in the opinion of the Investigator.
Note 1: Other protocol defined inclusion/exclusion criteria apply Note 2: Unless specified by Cohort, the criteria apply to both Cohorts

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

INVIVYD Investigative Site
Atlanta, Georgia, 30328
INVIVYD Investigative Site
Beaumont, Texas, 77706
INVIVYD Investigative Site
Burlington, Massachusetts, 01803
INVIVYD Investigative Site
Clearwater, Florida, 33756
INVIVYD Investigative Site
Dallas, Texas, 75230
INVIVYD Investigative Site
Edmond, Oklahoma, 73013
INVIVYD Investigative Site
Fullerton, California, 92835
INVIVYD Investigative Site
Hinesville, Georgia, 31313
INVIVYD Investigative Site
Long Beach, California, 90806
INVIVYD Investigative Site
Miami, Florida, 33186
INVIVYD Investigative Site
Morrisville, North Carolina, 27560
INVIVYD Investigative Site
Oak Brook, Illinois, 60523
INVIVYD Investigative Site
Rolling Hills Estates, California, 90274
INVIVYD Investigative Site
Salisbury, North Carolina, 28144
INVIVYD Investigative Site
San Diego, California, 92103
INVIVYD Investigative Site
Silver Spring, Maryland, 20904
INVIVYD Investigative Site
St. Petersburg, Florida, 33705
INVIVYD Investigative Site
Yukon, Oklahoma, 73099

Other trials in United States

About this study

Official title: A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19 (CANOPY)

A study to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2

Conditions: COVID-19, SARS-CoV-2
Being tested: VYD222 (pemivibart), Normal saline
Keywords: Immune Compromise, VYD222, SARS-CoV-2 Monoclonal Antibody, COVID-19 Prevention
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VYD222 (pemivibart)Drug
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Normal salineDrug
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.

Study groups in NCT06039449
Study group	Role	What they receive
Cohort A VYD222	Experimental	Not described Receives: Drug: VYD222 (pemivibart)
Cohort B VYD222	Experimental	Not described Receives: Drug: VYD222 (pemivibart)
Cohort B Placebo	Placebo comparator	Not described Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort A - Incidence of treatment emergent adverse events
Measured: Through Month 12
Cohort A - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
Measured: Day 28
Cohort B - Incidence of treatment emergent adverse events
Measured: Through Month 12

Secondary outcomes (14)

Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.
Measured: Day 28
Cohort A - sVNA titer by timepoint following VYD222 administration
Measured: Through Month 12
Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint
The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
Measured: Through Month 12
Cohort A - ADAs against VYD222
Measured: Through Month 12
Cohort A - Serum concentrations (PK) of VYD222
Measured: Through Month 12
Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19
RT-PCR-confirmed symptomatic COVID-19 is defined as RT-PCR-confirmed SARS-CoV-2 with an onset of symptoms occurring no more than 14 days from the date of the positive RT-PCR test sample collection, COVID-19-related hospitalization, or all-cause death.
Measured: Through Month 12
Cohort B - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
Measured: Day 28
Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.
Measured: Day 28
Cohort B - sVNA titer by timepoint following VYD222 administration
Measured: Through Month 12
Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint
The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
Measured: Through Month 12
Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset
Measured: Through Month 12
Cohort B - COVID-19-related death
Measured: Through Month 12
Cohort B - Serum concentrations (PK) of VYD222
Measured: Through Month 12
Cohort B - ADAs against VYD222
Measured: Through Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202319 Nov 2024

First posted15 Sep 2023
Study start8 Sep 2023
Primary completion19 Nov 2024
Study completion19 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 790 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06039449
Sponsor's protocol ID: VYD222-PREV-001
Status last verified: Dec 2024
First submitted: 8 Sep 2023
Last updated: 9 Dec 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Narayan K, Tosh K, Holmes A, Hu L, Dkottam SR, Yalcin I, Wingertzahn M. Serum Virus-Neutralizing Antibody Titers in Clinical Trial Participants With and Without Immunocompromise Receiving Pemivibart, a Long-Acting Monoclonal Antibody for COVID-19. J Infect Dis. 2026 Oct 15;234(4):e859-e868. doi: 10.1093/infdis/jiag269.
PubMed 42165235
Yalcin I, Hu L, West B, Narayan K, Holmes A, Wingertzahn MA. A Statistical Immune Correlates of Protection Model for Predicting Efficacy from Neutralizing Antibody Titers to Establish Immunobridging of Monoclonal Antibodies for Prevention of COVID-19. Infect Dis Ther. 2026 Apr;15(4):1007-1017. doi: 10.1007/s40121-026-01315-6. Epub 2026 Feb 16.
PubMed 41697535
Wolfe CR, Cohen J, Mahoney K, Holmes A, Betancourt N, Gupta D, Tosh K, Narayan K, Campanaro E, Katz C, Phelan AM, Yalcin I, Wingertzahn M, Hawn P, Schmidt P, Li Y, Popejoy M. Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From a Phase 3 Randomized Clinical Trial (CANOPY). Clin Infect Dis. 2025 Oct 6;81(3):439-450. doi: 10.1093/cid/ciaf265.
PubMed 40410927

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19 (CANOPY)
ClinicalTrials.gov ID: NCT06039449
Acronym / sponsor ID: VYD222-PREV-001
Conditions: COVID-19, SARS-CoV-2
Keywords: Immune Compromise, VYD222, SARS-CoV-2 Monoclonal Antibody, COVID-19 Prevention
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 790 participants (actual)
Lead sponsor: Invivyd, Inc.Industry (pharma, biotech, devices)
Study start: 8 Sep 2023 (actual)
Primary completion: 19 Nov 2024 (actual)
Study completion: 19 Nov 2024 (actual)
First posted: 15 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A study to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cohort A VYD222	Experimental	Drug: VYD222 (pemivibart)
Cohort B VYD222	Experimental	Drug: VYD222 (pemivibart)
Cohort B Placebo	Placebo comparator	Drug: Normal saline

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Is an adult aged ≥18 years or an adolescent aged 12 to <18 years and weighs at least 40 kg at the time of Screening.
Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at the time of Screening.
For Cohort A, has significant immune compromise from causes including solid tumor or hematologic malignancies, chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic stem cell transplant, primary immunodeficiency, advanced HIV infection, or receiving qualifying immunosuppressive therapies.
For Cohort B, is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings.
Agrees to defer receipt of any COVID-19 vaccination or booster for a minimum of 28 days after dosing.

Key exclusion criteria (6 listed)

For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before randomization.
Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization.
Prior known or suspected SARS-CoV-2 infection within 120 days before randomization.
Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before randomization.
Is acutely ill or has any symptoms suggestive of infection, in the opinion of the Investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VYD222 (pemivibart)Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.	Drug	Cohort A VYD222, Cohort B VYD222
Normal salineParticipants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.	Drug	Cohort B Placebo

Primary outcome

Cohort A - Incidence of treatment emergent adverse events
Time frame: Through Month 12
Cohort A - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
Time frame: Day 28
Cohort B - Incidence of treatment emergent adverse events
Time frame: Through Month 12

14 secondary outcomes

Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.
Time frame: Day 28
Cohort A - sVNA titer by timepoint following VYD222 administration
Time frame: Through Month 12
Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint
Time frame: Through Month 12
Cohort A - ADAs against VYD222
Time frame: Through Month 12
Cohort A - Serum concentrations (PK) of VYD222
Time frame: Through Month 12
Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19
Time frame: Through Month 12
Cohort B - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
Time frame: Day 28
Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.
Time frame: Day 28
Cohort B - sVNA titer by timepoint following VYD222 administration
Time frame: Through Month 12
Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint
Time frame: Through Month 12
Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset
Time frame: Through Month 12
Cohort B - COVID-19-related death
Time frame: Through Month 12
Cohort B - Serum concentrations (PK) of VYD222
Time frame: Through Month 12
Cohort B - ADAs against VYD222
Time frame: Through Month 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Derived from this study: PubMed 42165235Narayan K, Tosh K, Holmes A, Hu L, Dkottam SR, Yalcin I, Wingertzahn M. Serum Virus-Neutralizing Antibody Titers in Clinical Trial Participants With and Without Immunocompromise Receiving Pemivibart, a Long-Acting Monoclonal Antibody for COVID-19. J Infect Dis. 2026 Oct 15;234(4):e859-e868. doi: 10.1093/infdis/jiag269.
Derived from this study: PubMed 41697535Yalcin I, Hu L, West B, Narayan K, Holmes A, Wingertzahn MA. A Statistical Immune Correlates of Protection Model for Predicting Efficacy from Neutralizing Antibody Titers to Establish Immunobridging of Monoclonal Antibodies for Prevention of COVID-19. Infect Dis Ther. 2026 Apr;15(4):1007-1017. doi: 10.1007/s40121-026-01315-6. Epub 2026 Feb 16.
Derived from this study: PubMed 40410927Wolfe CR, Cohen J, Mahoney K, Holmes A, Betancourt N, Gupta D, Tosh K, Narayan K, Campanaro E, Katz C, Phelan AM, Yalcin I, Wingertzahn M, Hawn P, Schmidt P, Li Y, Popejoy M. Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From a Phase 3 Randomized Clinical Trial (CANOPY). Clin Infect Dis. 2025 Oct 6;81(3):439-450. doi: 10.1093/cid/ciaf265.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VYD222 (pemivibart) and Normal saline in people with COVID-19 and SARS-CoV-2, run by Invivyd, Inc. at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort A - Incidence of treatment emergent adverse events (time frame: Through Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06039449, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.