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VYD2311-SD

Phase 3

COVID-19 | Small molecule | Infectious Disease |Invivyd, Inc.|Last Updated: Jun 10, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,770
FDA Designations
FAST_TRACK
Clinical trial landscape

VYD2311-SD · 1 trial · 1 indication

Phase 3 1
NCT07298434Study of VYD2311 for the Prevention of COVID-19COVID-19
ACTIVE NOT_RECRUITING1,770 Analytics
PHASE3ACTIVE NOT_RECRUITING
Study of VYD2311 for the Prevention of COVID-19
COVID-19
NCT072984341,770
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Study Endpoints
Primary Endpoints
RT-PCR-confirmed symptomatic COVID-19 through Day 90
90 days
Secondary Endpoints
Assessment of safety based on treatment-emergent adverse events, injection site reactions, and hypersensitivity reactions through Day 90
90 days
Serum concentrations of VYD2311 through Day 90
90 days
Incidence of ADAs against VYD2311 through Day 90
90 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VYD2311-SD (single dose)ACTIVE_COMPARATORVYD2311 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_COMPARATORVYD2311 administered via IM injection on Day 1, Day 30, and Day 60
PlaceboPLACEBO_COMPARATORNormal saline administered by IM injection on Day 1, Day 30, and Day 60
Interventions
NameTypeDescription
VYD2311-SDDRUGVYD2311-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-MDDRUGVYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with VYD2311
PlaceboDRUGIntramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline)
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Eligibility Criteria
Age Range12 Years to 100 Years
SexALL
Healthy VolunteersYes
Study Sites20

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...

Countries:United States
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Competitive Landscape -COVID-19 37 trials
CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE8PHASE3ibuzatrelvir, remdesivir
BioNTech SE Sponsored ADRBNTX3PHASE3BNT162b2
Merck & Co., Inc.MRK1PHASE3Molnupiravir
Invivyd, Inc.IVVD2PHASE3VYD2311-SD, VYD2311-MD
Vanda Pharmaceuticals Inc.VNDA1PHASE3Tradipitant
BioVie Inc. Class ABIVI1PHASE2NE3107
ImmunityBio IncIBRX2PHASE2Anktiva
Traws Pharma, Inc.TRAW1PHASE2Ratutrelvir non-randomised, Paxlovid, Ratutrelvir
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Unity Health TorontoUBX1PHASE3Paxlovid, Antioxidant
Moderna, Inc.MRNA1 - SPIKEVAX Bivalent BA.1, SPIKEVAX XBB.1.5, SPIKEVAX JN.1
Abbott LaboratoriesABT1N/AUndisclosed
Design Therapeutics, Inc.DSGN1EARLY_PHASE1COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use
Jade Biosciences, Inc.JBIO1N/AUndisclosed
Structure Therapeutics, Inc. Sponsored ADRGPCR1N/AUndisclosed
Co-Diagnostics, Inc.CODX1 - Undisclosed
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Recent Changes (Last 90 Days)
MEDIUMJun 10, 2026NCT07298434Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 10, 2026NCT07298434Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMMay 26, 2026NCT07298434Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07298434studyFirstPostDate: changed