Phase
Condition
Covid-19
Treatment
Placebo
VYD2311-SD
VYD2311-MD
Clinical Study ID
Ages 12-100 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 ifpermitted by the local health authorities and local ethics committees.
Has uninterrupted access to a device (eg, mobile phone, tablet) enabled to receivestudy reminders (eg, SMS text messages). The parent/guardian of adolescentparticipants will receive the study reminders.
Provides written documentation of informed consent by signing a currentIEC/IRB-approved ICF at the time of Screening. In the case of adolescents, parentalinformed 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 theInvestigator.
For participants assigned female sex at birth:
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 contraceptionthrough 6 months after any dosing, and has a negative pregnancy test result onDay 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 If pregnant participants are eligible for enrollment, this criterion is no longer applicable.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
Exclusion Criteria:
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 orplans to receive pemivibart within 90 days after Day 1.
Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currentlycirculating variants within 120 days before Day 1 or plans to receive convalescentplasma 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 daysbefore Day 1.
Is acutely ill, including symptoms suggestive of SARS-CoV-2 infection, in theopinion of the investigator or has a fever ≥38 o C (≥100.4 o F) within 3 days of Day
Received or plans to receive a non-COVID-19 vaccine within 7 days before or aftereach dose of study drug.
NOTE: Other protocol defined inclusion/exclusion criteria apply
Study Design
Connect with a study center
Invivyd Investigative Site
Long Beach, California 90806
United StatesSite Not Available
Inviviyd Investigative Site
San Diego, California 92103
United StatesSite Not Available
Invivyd Investigative Site
Orlando, Florida 32819
United StatesSite Not Available
Invivyd Investigative Site
Hinesville, Georgia 31313
United StatesSite Not Available
Invivyd Investigative Site
Melrose Park, Illinois 60160
United StatesSite Not Available
Invivyd Investigative Site
Lenexa, Kansas 66219
United StatesSite Not Available
Invivyd Investigative Site
Silver Spring, Maryland 20904
United StatesSite Not Available
Invivyd Investigative Site
Burlington, Massachusetts 01803
United StatesSite Not Available
Invivyd Investigative Site
Southfield, Michigan 48034
United StatesSite Not Available
Invivyd Investigative Site
Maplewood, Minnesota 55109
United StatesSite Not Available
Invivyd Investigative Site
Independence, Missouri 64055
United StatesSite Not Available
Invivyd Investigative Site
Jersey City, New Jersey 07306
United StatesSite Not Available
Invivyd Investigative Site
The Bronx, New York 10455
United StatesSite Not Available
Invivyd Investigative Site
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Invivyd Investigative Site
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
Invivyd Investigative Site
Goodlettsville, Tennessee 37072
United StatesSite Not Available
Invivyd Investigative Site
Houston, Texas 77065
United StatesSite Not Available
Invivyd Investigative Site
Houston-2, Texas 77065
United StatesSite Not Available
Invivyd Investigative Site
Irving, Texas 75061
United StatesSite Not Available
Invivyd Investigative Site
Sugar Land, Texas 46254
United StatesSite Not Available
Invivyd Investigative Site
Houston 4699066, Texas 4736286 77065
United StatesSite Not Available

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