A study to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
790
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.
INVIVYD Investigative Site
Fullerton, California, United States
INVIVYD Investigative Site
Long Beach, California, United States
Cohort A - Incidence of treatment emergent adverse events
Time frame: Through Month 12
Cohort A - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
Time frame: Day 28
Cohort B - Incidence of treatment emergent adverse events
Time frame: Through Month 12
Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.
Time frame: Day 28
Cohort A - sVNA titer by timepoint following VYD222 administration
Time frame: Through Month 12
Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint
The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
Time frame: Through Month 12
Cohort A - ADAs against VYD222
Time frame: Through Month 12
Cohort A - Serum concentrations (PK) of VYD222
Time frame: Through Month 12
Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19
RT-PCR-confirmed symptomatic COVID-19 is defined as RT-PCR-confirmed SARS-CoV-2 with an onset of symptoms occurring no more than 14 days from the date of the positive RT-PCR test sample collection, COVID-19-related hospitalization, or all-cause death.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
INVIVYD Investigative Site
Rolling Hills Estates, California, United States
INVIVYD Investigative Site
San Diego, California, United States
INVIVYD Investigative Site
Clearwater, Florida, United States
INVIVYD Investigative Site
Miami, Florida, United States
INVIVYD Investigative Site
St. Petersburg, Florida, United States
INVIVYD Investigative Site
Atlanta, Georgia, United States
INVIVYD Investigative Site
Hinesville, Georgia, United States
INVIVYD Investigative Site
Oak Brook, Illinois, United States
...and 8 more locations
Time frame: Through Month 12
Cohort B - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
Time frame: Day 28
Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.
Time frame: Day 28
Cohort B - sVNA titer by timepoint following VYD222 administration
Time frame: Through Month 12
Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint
The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
Time frame: Through Month 12
Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset
Time frame: Through Month 12
Cohort B - COVID-19-related death
Time frame: Through Month 12
Cohort B - Serum concentrations (PK) of VYD222
Time frame: Through Month 12
Cohort B - ADAs against VYD222
Time frame: Through Month 12