Phase
Condition
Covid-19
Treatment
VYD2311-SD
VYD2311-MD
Placebo
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 If pregnant participants are eligible for enrollment, this criterion is no longer applicable.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 5367929, California 5332921 90806
United StatesActive - Recruiting
Inviviyd Investigative Site
San Diego 5391811, California 5332921 92103
United StatesActive - Recruiting
Invivyd Investigative Site
Orlando 4167147, Florida 4155751 32819
United StatesActive - Recruiting
Invivyd Investigative Site
Hinesville 4200671, Georgia 4197000 31313
United StatesActive - Recruiting
Invivyd Investigative Site
Melrose Park 4901868, Illinois 4896861 60160
United StatesActive - Recruiting
Invivyd Investigative Site
Lenexa 4274356, Kansas 4273857 66219
United StatesActive - Recruiting
Invivyd Investigative Site
Silver Spring 4369596, Maryland 4361885 20904
United StatesActive - Recruiting
Invivyd Investigative Site
Burlington 4931737, Massachusetts 6254926 01803
United StatesActive - Recruiting
Invivyd Investigative Site
Southfield 5010636, Michigan 5001836 48034
United StatesActive - Recruiting
Invivyd Investigative Site
Maplewood 5036588, Minnesota 5037779 55109
United StatesActive - Recruiting
Invivyd Investigative Site
Independence 4391812, Missouri 4398678 64055
United StatesActive - Recruiting
Invivyd Investigative Site
Jersey City 5099836, New Jersey 5101760 07306
United StatesActive - Recruiting
Invivyd Investigative Site
The Bronx 5110266, New York 5128638 10455
United StatesActive - Recruiting
Invivyd Investigative Site
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
Invivyd Investigative Site
Myrtle Beach 4588718, South Carolina 4597040 29572
United StatesActive - Recruiting
Invivyd Investigative Site
Goodlettsville 4625282, Tennessee 4662168 37072
United StatesActive - Recruiting
Invivyd Investigative Site
Houston 4699066, Texas 4736286 77065
United StatesActive - Recruiting
Invivyd Investigative Site
Houston-2, Texas 4736286 77065
United StatesActive - Recruiting
Invivyd Investigative Site
Irving 4700168, Texas 4736286 75061
United StatesActive - Recruiting
Invivyd Investigative Site
Sugar Land 4734825, Texas 4736286 46254
United StatesActive - Recruiting

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