A Clinical Trial to Learn More About an Investigational Therapy (VYD222) for Prevention of COVID-19 in People That Are Immune Compromised

Trial ID: VYD222

Trial Details

This trial is being done to see if VYD222 can help prevent COVID-19 in people who are significantly immunocompromised (have a weakened immune system).

The trial is currently open to adults (at least 18 years old) who are significantly immunocompromised, which may be caused by certain medical conditions or treatments. Participants will get VYD222 through an IV infusion, which is a needle into the vein (also called “intravenous”).

One of the main goals of this trial is to learn about any medical issues the participants might have after getting VYD222. The other main goal is to see if VYD222 helps protect the participant against COVID-19.

Estimated Enrollment

300 Participants

Phase

3

Eligibility Criteria

Participants must:

Be at least 18 years old
Be significantly immunocompromised, which may be caused by certain medical conditions (like cancer or HIV) or as a result of taking immunosuppressive treatments (treatments that affect how your immune system works), such as high-dose corticosteroids (prednisone 20 mg or more per day or equivalent), rituximab, ocrelizumab, ofatumumab, cyclophosphamide, cisplatin, chlorambucil, 5-fluorouracil (5-FU), capecitabine, methotrexate, tacrolimus, mycophenolate mofetil, adalimumab, etanercept, infliximab, tocilizumab
Test negative for COVID-19 at the start of the trial

Participants must not:

Have had COVID-19 within 4 months before joining the trial
Have symptoms of COVID-19 at the start of the trial
Have had any of the following within 4 months before joining the trial: “convalescent plasma” (transfusion of blood from someone who has recovered from COVID-19) or a “COVID-19 monoclonal antibody” (a type of protein made to help the immune system fight COVID 19).
Have an exposure to someone with confirmed or suspected COVID-19 within 5 days before joining the trial
Have had any SARS-CoV-2 vaccine within 14 days prior to study Day 1.

About the Condition/Disease Overview:

Coronavirus disease 2019, also called “COVID-19”, is a disease caused by a virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 can spread easily among people. Some people with COVID-19 may not have any symptoms at all. But, some may have fever, chills, loss of sense of taste and smell, sore throat, or difficulty breathing. These symptoms are often mild but can also be serious for some people, including those who have certain medical conditions.

In this trial, researchers are studying an investigational monoclonal antibody called “VYD222” for the prevention of COVID-19. VYD222 may work differently from COVID-19 vaccines, called “messenger RNA (or mRNA) vaccines” (vaccines that work by teaching our cells how to make copies of a protein that will help our body recognize and fight the virus once it enters our body). Additionally, some people, due to medical conditions or medications, may be immune compromised and therefore do not develop sufficient levels of protective antibodies from the COVID-19 vaccine.

What Will Happen in This Trial

If you are interested in joining this trial, you will need to meet with a trial doctor. This will be done at a trial site. A trial doctor will explain the trial to you. If you agree to join and provide written informed consent to do so,, the trial doctors and other trial staff will give you an examination and ask you questions about your medical history, medicines you are taking, and vaccines you have received to make sure you are eligible to take part in the trial. You will also be checked for COVID-19 before getting a dose of VYD222.

If the trial doctor decides that you are eligible to join, you will get VYD222. You will get 2 doses of VYD222 via infusion about 3 months apart.

You will have scheduled in person visits (done at a trial site) for the next 12 months after your first VYD222 dose.

Once the study doctor makes sure that you meet the study requirements after Screening, study staff will:

Collect a sample using a nasopharyngeal COVID-19 test, with a swab placed far back in your nose
Take blood samples for laboratory tests
Perform a complete physical examination
Take vital signs, such as blood pressure, heart rate, breathing rate, body temperature, and blood oxygen level

You will then receive a dose of the study drug, VYD222, by IV infusion. A needle will be used to inject the study drug directly into a vein in your arm.

You will receive a second dose of VYD222 by IV infusion around 90 days later, at your Month 3 visit. The study doctor will decide if there is any reason you should not receive a second dose. Even if you do not get a second dose, you will stay in the study through your Month 12 visit.

Each infusion will take approximately 30 minutes. You will be observed by the study staff for 1 hour after each infusion to ensure your safety. Your study doctor may also ask you to come in for extra visits if you have symptoms of COVID-19 or if needed to check on any health issues you might have during the study.

If you test positive for COVID-19 during the trial, virtual check-ins will also be done to keep track of your symptoms.

In total, the participants will have about 7 in-person visits and 1 virtual visits over a period of about 12.5 months. If you have qualifying symptoms for COVID-19 or other health issues, you may have additional visits.

Find a Location Near You

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Sites are located in the cities/states identified with the red pin:

Travel Support

Please note that participants will receive a stipend to cover study-related costs and inconveniences. More details about this will be explained by the trial site and included in your informed consent form. Please ask site staff about travel support and other support offered for this trial.

Frequently Asked Questions (FAQs)

What is a clinical trial?

Through clinical research, scientists and doctors can determine whether a new medical strategy, drug, vaccine, or device is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments. Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join.

What does a typical clinical trial look like?

Clinical trials help determine the safety and effectiveness of treatments. A research plan, also called a protocol, is created before the trial starts. The protocol describes who can join the trial, what treatments the participants will receive, what questions the researchers will seek to answer, how long the trial will last, and how participant privacy and safety will be protected during the trial.

A clinical trial may compare a new treatment to a standard treatment option that is already available, to a placebo (an identical-looking treatment with no active ingredient), or to no intervention at all. Before you decide to join a clinical trial, the trial team will explain all of the trial details. If you qualify for this study, you will receive the investigational VYD222 study drug and not placebo.

What are Phase 3 clinical trials?

When new drugs are being studied to prevent or treat diseases, they are tested in stages, or “phases.” If a drug is successful in Phase 1, it moves to Phase 2. If it is successful in Phase 2, it moves to Phase 3.

Drugs that enter Phase 3 trials have already been studied in other clinical trials. Researchers have gathered information about the safety of the drug already, usually in up to several hundred people. Phase 3 trials usually include large numbers of participants. Some Phase 3 trials are conducted in multiple countries and include many clinical sites. Phase 3 trials are used to collect even more information about how safe a drug is and how well it works.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this website by clicking the “Get Started” button.

Can I quit the trial at any time?

Trial volunteers have the right to drop out of the trial at any time for any reason or no reason at all. The trial doctor or sponsor also has the right to discontinue a trial volunteer at any time for the participant’s safety or if the participant no longer meets the trial requirements.

What personal information is collected about me for the trial?

The trial doctor and other site staff will collect your personal information. This may include:

Your name, address, telephone number, and health insurance number, where applicable
Your age, sex, and ethnic and racial background
Your lifestyle information
Your medical history details
Your vaccine history and your response to vaccines (if known)
Data resulting from testing your biological samples

Who has access to my information?

The information you provide in this prescreener will be shared with a clinical site via secure shared portal. All of the data you provide (contact information and responses to the prescreener) to Citeline will be anonymized 1 year after being shared with the clinical site staff.

Once you are connected to a site, all personal information collected for this study will be securely stored in the study medical records at the clinical study site. Sponsor staff, review boards, ethics committees (that approve and monitor studies), and others who have a need to know, such as our data hosting provider and government regulators, may check study records. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify study procedures and/or data.

This trial is not actively recruiting.