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New monthly shot could stop COVID-19 before it starts

NCT ID NCT07298434

Prevention Sponsor: Invivyd, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called VYD2311, a monoclonal antibody that blocks the COVID-19 virus from entering cells. About 1,770 adults and teens aged 12 and older receive either VYD2311 or a placebo as a monthly shot for 3 months. The goal is to see if it safely prevents COVID-19 infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,770 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: 1. 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. 2. 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. 3. 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. 4. 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. 5. For participants assigned female sex at birth: 1. Is not of childbearing potential, OR 2. 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. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Prior receipt of VYD2311 or pemivibart (VYD222) within 12 months before Day 1 or plans to receive pemivibart within 90 days after Day 1. 2. 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. 3. Tests positive for current SARS-CoV-2 infection by local RAT or RT-PCR on Day 1. 4. Prior known or suspected SARS-CoV-2 infection within 120 days before Day 1. 5. Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before Day 1. 6. 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. 7. 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

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

Contacts and locations

Locations

  • Inviviyd Investigative Site

    San Diego, California, 92103, United States

  • Invivyd Investigative Site

    Long Beach, California, 90806, United States

  • Invivyd Investigative Site

    Orlando, Florida, 32819, United States

  • Invivyd Investigative Site

    Hinesville, Georgia, 31313, United States

  • Invivyd Investigative Site

    Melrose Park, Illinois, 60160, United States

  • Invivyd Investigative Site

    Lenexa, Kansas, 66219, United States

  • Invivyd Investigative Site

    Silver Spring, Maryland, 20904, United States

  • Invivyd Investigative Site

    Burlington, Massachusetts, 01803, United States

  • Invivyd Investigative Site

    Southfield, Michigan, 48034, United States

  • Invivyd Investigative Site

    Maplewood, Minnesota, 55109, United States

  • Invivyd Investigative Site

    Independence, Missouri, 64055, United States

  • Invivyd Investigative Site

    Jersey City, New Jersey, 07306, United States

  • Invivyd Investigative Site

    The Bronx, New York, 10455, United States

  • Invivyd Investigative Site

    Philadelphia, Pennsylvania, 19107, United States

  • Invivyd Investigative Site

    Myrtle Beach, South Carolina, 29572, United States

  • Invivyd Investigative Site

    Goodlettsville, Tennessee, 37072, United States

  • Invivyd Investigative Site

    Houston, Texas, 77065, United States

  • Invivyd Investigative Site

    Houston-2, Texas, 77065, United States

  • Invivyd Investigative Site

    Irving, Texas, 75061, United States

  • Invivyd Investigative Site

    Sugar Land, Texas, 46254, United States

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