Study of VYD2311 for the Prevention of COVID-19 (NCT07298434) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of VYD2311 for the Prevention of COVID-19
United States1,770 participantsStarted 2026-01-08
Plain-language 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. 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.
Who can participate
Age range
12 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
RT-PCR-confirmed symptomatic COVID-19 through Day 90
. 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.
Exclusion criteria
. 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.
. 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.