COVID-19Phase 3DECLARATIONNCT07298434
Study of VYD2311 for the Prevention of COVID-19
A Phase 3 study testing VYD2311-SD and VYD2311-MD in people with COVID-19, run by Invivyd, Inc. at 20 sites in United States.
Trial summary
The main purpose of this study is to test an investigational drug known as VYD2311, which is being developed to lower the risk of getting COVID-19. VYD2311 is a monoclonal antibody that attaches to the virus that causes COVID-19 and helps block it from entering your cells. Read more about this study
- Who is it for?
- Ages 12 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- VYD2311-SD and VYD2311-MD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,770 participants
- Where
- 20 sitesUnited States
- Study dates
- 8 Jan 2026to Aug 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all the following criteria apply:
- Is an adult aged ≥18 years or an adolescent aged 12 to <18 years weighing at least 40 kg at the time of Screening. Note: Adolescent enrollment is allowed only if permitted by the local health authorities and local ethics committees.
- Has uninterrupted access to a device (eg, mobile phone, tablet) enabled to receive study reminders (eg, SMS text messages). The parent/guardian of adolescent participants will receive the study reminders.
- Provides written documentation of informed consent by signing a current IEC/IRB-approved ICF at the time of Screening. In the case of adolescents, parental informed consent and adolescent assent must also be obtained.
- Is able to understand and comply with study requirements/procedures (if applicable, with assistance by a caregiver, surrogate, or LAR) based on the assessment of the Investigator.
- For participants assigned female sex at birth:
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- Is not of childbearing potential, OR
- Is of childbearing potential and practicing adequate contraception for at least 7 days before dosing on Day 1, agrees to practice adequate contraception through 6 months after any dosing, and has a negative pregnancy test result on Day 1.
- Note: Pregnant participants will be eligible for enrollment after iDMC review of safety data only upon Sponsor communication to sites and only in regions permitted by local health authorities and local ethics committees. If pregnant participants are eligible for enrollment, this criterion is no longer applicable.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Prior receipt of VYD2311 or pemivibart (VYD222) within 12 months before Day 1 or plans to receive pemivibart within 90 days after Day 1.
- Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants within 120 days before Day 1 or plans to receive convalescent plasma or an active SARS-CoV-2 mAb within 90 days after Day 1.
- Tests positive for current SARS-CoV-2 infection by local RAT or RT-PCR on Day 1.
- Prior known or suspected SARS-CoV-2 infection within 120 days before Day 1.
- Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before Day 1.
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- Is acutely ill, including symptoms suggestive of SARS-CoV-2 infection, in the opinion of the investigator or has a fever ≥38 o C (≥100.4 o F) within 3 days of Day 1.
- Received or plans to receive a non-COVID-19 vaccine within 7 days before or after each dose of study drug.
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Invivyd Investigative Site
Burlington, Massachusetts, 01803
Invivyd Investigative Site
Goodlettsville, Tennessee, 37072
Invivyd Investigative Site
Hinesville, Georgia, 31313
Invivyd Investigative Site
Houston, Texas, 77065
Invivyd Investigative Site
Houston-2, Texas, 77065
Invivyd Investigative Site
Independence, Missouri, 64055
Invivyd Investigative Site
Irving, Texas, 75061
Invivyd Investigative Site
Jersey City, New Jersey, 07306
Invivyd Investigative Site
Lenexa, Kansas, 66219
Invivyd Investigative Site
Long Beach, California, 90806
Invivyd Investigative Site
Maplewood, Minnesota, 55109
Invivyd Investigative Site
Melrose Park, Illinois, 60160
Invivyd Investigative Site
Myrtle Beach, South Carolina, 29572
Invivyd Investigative Site
Orlando, Florida, 32819
Invivyd Investigative Site
Philadelphia, Pennsylvania, 19107
Inviviyd Investigative Site
San Diego, California, 92103
Invivyd Investigative Site
Silver Spring, Maryland, 20904
Invivyd Investigative Site
Southfield, Michigan, 48034
Invivyd Investigative Site
Sugar Land, Texas, 46254
Invivyd Investigative Site
The Bronx, New York, 10455
About this study
Official title: A Phase 3, Randomized, Triple-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VYD2311 for the Prevention of COVID-19 in Adults and Adolescents
The main purpose of this study is to test an investigational drug known as VYD2311, which is being developed to lower the risk of getting COVID-19. VYD2311 is a monoclonal antibody that attaches to the virus that causes COVID-19 and helps block it from entering your cells. It is being tested in adults and adolescents at least 12 years old. Participants in this study will be given a "study drug" that will be either VYD2311 or placebo.
The study drug will be given as a shot into the muscle in the participant's upper thigh or upper arm once a month with a total of 3 shots during the study.
This study will help researchers see how well VYD2311 works to prevent COVID-19 during the 90 days after the first shot. The study will also look at the safety and tolerability of VYD2311, how the study drug is processed by the body (pharmacokinetics), how the immune system reacts to the study drug (immunogenicity), and how well VYD2311 can block the virus from infecting cells (neutralization). To do these tests, your blood will be drawn at certain times during the study.
- Conditions
- COVID-19
- Being tested
- VYD2311-SD, VYD2311-MD, Placebo
- Keywords
- COVID, COVID-19, mAb, antibody, COVID-19 prevention, VYD2311, SARS-CoV-2 Monocloncal Antibody
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VYD2311-SDDrug
VYD2311-SD (single-dose arm): Intramuscular injection dosing on Day 1 with VYD2311 and Intramuscular injection dosing Placebo (normal saline) on Day 30 and Day 60
VYD2311-MDDrug
VYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with VYD2311
PlaceboDrug
Intramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline)
| Study group | Role | What they receive |
|---|---|---|
| VYD2311-SD (single dose) | Active comparator | VYD2311 administered via IM injection on Day 1, followed by placebo injection (0.9% sodium chloride [normal saline]) on Day 30 and Day 60 Receives: Drug: VYD2311-SD |
| VYD2311-MD (multidose) | Active comparator | VYD2311 administered via IM injection on Day 1, Day 30, and Day 60 Receives: Drug: VYD2311-MD |
| Placebo | Placebo comparator | Normal saline administered by IM injection on Day 1, Day 30, and Day 60 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
RT-PCR-confirmed symptomatic COVID-19 through Day 90
Measured: 90 days
Secondary outcomes (4)
Assessment of safety based on treatment-emergent adverse events, injection site reactions, and hypersensitivity reactions through Day 90
Measured: 90 days
Serum concentrations of VYD2311 through Day 90
Measured: 90 days
Incidence of ADAs against VYD2311 through Day 90
Measured: 90 days
Calculated sVNA titers (VYD2311 serum concentration/variant IC50) against relevant SARS-CoV-2 variants through Day 90
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start8 Jan 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Invivyd, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298434
- Sponsor's protocol ID
- VYD2311-PREV-002
- Acronym
- DECLARATION
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Triple-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VYD2311 for the Prevention of COVID-19 in Adults and Adolescents
- ClinicalTrials.gov ID
- NCT07298434
- Acronym / sponsor ID
- DECLARATION / VYD2311-PREV-002
- Conditions
- COVID-19
- Keywords
- COVID, COVID-19, mAb, antibody, COVID-19 prevention, VYD2311, SARS-CoV-2 Monocloncal Antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,770 participants (estimated)
- Lead sponsor
- Invivyd, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 23 Dec 2025 (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.
The main purpose of this study is to test an investigational drug known as VYD2311, which is being developed to lower the risk of getting COVID-19. VYD2311 is a monoclonal antibody that attaches to the virus that causes COVID-19 and helps block it from entering your cells. It is being tested in adults and adolescents at least 12 years old. Participants in this study will be given a "study drug" that will be either VYD2311 or placebo.
The study drug will be given as a shot into the muscle in the participant's upper thigh or upper arm once a month with a total of 3 shots during the study.
This study will help researchers see how well VYD2311 works to prevent COVID-19 during the 90 days after the first shot. The study will also look at the safety and tolerability of VYD2311, how the study drug is processed by the body (pharmacokinetics), how the immune system reacts to the study drug (immunogenicity), and how well VYD2311 can block the virus from infecting cells (neutralization). To do these tests, your blood will be drawn at certain times during the study.
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 |
|---|---|---|
| VYD2311-SD (single dose) | Active comparator | Drug: VYD2311-SDVYD2311 administered via IM injection on Day 1, followed by placebo injection (0.9% sodium chloride [normal saline]) on Day 30 and Day 60 |
| VYD2311-MD (multidose) | Active comparator | Drug: VYD2311-MDVYD2311 administered via IM injection on Day 1, Day 30, and Day 60 |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline administered by IM injection on Day 1, Day 30, and Day 60 |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Participants are eligible to be included in the study only if all the following criteria apply:
- Is an adult aged ≥18 years or an adolescent aged 12 to <18 years weighing at least 40 kg at the time of Screening. Note: Adolescent enrollment is allowed only if permitted by the local health authorities and local ethics committees.
- Has uninterrupted access to a device (eg, mobile phone, tablet) enabled to receive study reminders (eg, SMS text messages). The parent/guardian of adolescent participants will receive the study reminders.
- Provides written documentation of informed consent by signing a current IEC/IRB-approved ICF at the time of Screening. In the case of adolescents, parental informed consent and adolescent assent must also be obtained.
- Is able to understand and comply with study requirements/procedures (if applicable, with assistance by a caregiver, surrogate, or LAR) based on the assessment of the Investigator.
Key exclusion criteria (9 listed)
- Prior receipt of VYD2311 or pemivibart (VYD222) within 12 months before Day 1 or plans to receive pemivibart within 90 days after Day 1.
- Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants within 120 days before Day 1 or plans to receive convalescent plasma or an active SARS-CoV-2 mAb within 90 days after Day 1.
- Tests positive for current SARS-CoV-2 infection by local RAT or RT-PCR on Day 1.
- Prior known or suspected SARS-CoV-2 infection within 120 days before Day 1.
- Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before Day 1.
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 |
|---|---|---|
| VYD2311-SDVYD2311-SD (single-dose arm): Intramuscular injection dosing on Day 1 with VYD2311 and Intramuscular injection dosing Placebo (normal saline) on Day 30 and Day 60 | Drug | VYD2311-SD (single dose) |
| VYD2311-MDVYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with VYD2311 | Drug | VYD2311-MD (multidose) |
| PlaceboIntramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline) | Drug | Placebo |
Primary outcome
RT-PCR-confirmed symptomatic COVID-19 through Day 90
Time frame: 90 days
4 secondary outcomes
Assessment of safety based on treatment-emergent adverse events, injection site reactions, and hypersensitivity reactions through Day 90
Time frame: 90 days
Serum concentrations of VYD2311 through Day 90
Time frame: 90 days
Incidence of ADAs against VYD2311 through Day 90
Time frame: 90 days
Calculated sVNA titers (VYD2311 serum concentration/variant IC50) against relevant SARS-CoV-2 variants through Day 90
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- 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.
20 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 VYD2311-SD and VYD2311-MD in people with COVID-19, run by Invivyd, Inc. at 20 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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
This study is still under way. Results are not available in the source record yet.
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?
RT-PCR-confirmed symptomatic COVID-19 through Day 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.