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Virus Therapy

VYD222 for COVID-19 Prevention

Phase 3
Waitlist Available
Research Sponsored by Invivyd, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you at least 18 years old?
Have you been told by a doctor that you are moderately or severely immunocompromised (have a significantly weakened immune system) because of a medical condition (like cancer or HIV) or immunosuppressive treatment (treatment that affects how your immune system works)?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through month 12
Awards & highlights

Study Summary

This trial studies a potential drug to prevent COVID-19 in people with weak immune systems and those exposed to the virus.

Who is the study for?
This trial is for adults and those aged 12 or older who are at risk of COVID-19 exposure. Participants must be over 18, not have had COVID-19 or its symptoms recently, and should not have received certain COVID-19 treatments in the past 4 months. They need to be moderately or severely immunocompromised due to conditions like cancer, HIV, or specific treatments.Check my eligibility
What is being tested?
The study tests VYD222's effectiveness in preventing COVID-19 among people with weakened immune systems. It compares VYD222 with a placebo (normal saline). The goal is to see if VYD222 can protect against coronavirus when one's immunity is compromised.See study design
What are the potential side effects?
While the potential side effects of VYD222 aren't specified here, similar preventive treatments may cause reactions at the injection site, fatigue, headache, muscle pain, chills, fever, nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and through month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A - Incidence of treatment emergent adverse events
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.
Cohort B - Incidence of treatment emergent adverse events
Secondary outcome measures
Cohort A - ADAs against VYD222
Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19
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
+13 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort B VYD222Experimental Treatment1 Intervention
Group II: Cohort A VYD222Experimental Treatment1 Intervention
Group III: Cohort B PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Invivyd, Inc.Lead Sponsor
4 Previous Clinical Trials
6,380 Total Patients Enrolled
4 Trials studying COVID-19
6,380 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety profile does Cohort A VYD222 possess?

"Our team at Power have assigned Cohort A VYD222 a score of 3, indicating that there is robust evidence in favor of its safety due to the fact it has reached Phase 3 trials. This means multiple studies have lent support for both efficacy and security."

Answered by AI

Are there available slots for enrolment in this clinical trial?

"According to the clinicaltrials.gov listing, this trial is currently sourcing participants. It was first published on September 8th 2023 and underwent its most recent update around that same date."

Answered by AI

What is the current number of participants registered for this trial?

"That's correct. According to the information posted on clinicaltrials.gov, this trial is actively recruiting 750 patients from 16 different medical centres. The listing was first uploaded and last edited on September 8th 2023 respectively."

Answered by AI

How numerous are the locations administering this experiment?

"Presently, this medical trial is accepting patients from 16 separate sites. Among them are Fullerton, Long Beach and Rolling Hills Estates as well as many others. It would be prudent to select the closest clinic to you in order to reduce any travel-related demands associated with your participation."

Answered by AI

Who else is applying?

What site did they apply to?
INVIVYD Investigative Site
Skylight Health Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

I take Humira. Try help to the research firm new medicine. I’m very sick. 23 days. Paxlovid, then steroids.
PatientReceived no prior treatments
To help test new drugs and/ways to help mitigate diseases. I have Vitiligo and understand it is an autoimmunity deficiency condition.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Would like more information about treatment. Does everyone receive it or is placebo part of trial?
PatientReceived no prior treatments
Is there an interaction with the trial drug and the medication I am taking for Ulcerative Colitis (Xeljanz among others). and heart medications? Will I still be able to take the boosters as they become available?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
2023. "A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06039449.
~395 spots leftby Dec 2024
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