Bio-Linked

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A Phase 2/3 Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID-19 (EVADE)

This trial is evaluating a potential therapy to prevent COVID-19 infection in people who live/work in an environment that may put them at risk for possible exposure to COVID-19.

Trial ID: NCT04859517

Trial Details

The purpose of the EVADE study is to evaluate an investigational medicine called ADG20, a monoclonal antibody, in individuals (18 years or older) who have no known history of COVID-19 and who have not received the COVID-19 vaccine.

Researchers want to see if ADG20 can prevent COVID-19. If you have questions about this study or would like to prescreen over the phone, please call (855) 720-1412.

Estimated Enrollment

3000 Participants

Phase

2/3

Eligibility Criteria

Participants must:

Be male or female 18 years of age or older
Weigh at least 40 kg or 88 lbs
Test negative for COVID-19 (prior or current infection) at screening
Live, work, go to school, or socialize in areas that may place them at high risk for being exposed to COVID-19
Agree to not get vaccinated against COVID-19 in the next 6 months

Participants must not:

Have previously received a COVID-19 vaccine
Have participated in a clinical trial or received an investigational product within the last 30 days
Have a current active illness (ex. Fever, chills, cough, headache, etc.)
Have plans to receive any type of vaccine (ex. Flu vaccine) within the next month

What Will Happen in This Study

You will be asked to attend study visits with a doctor or nurse, some of which will be in person and others over the telephone, and you will need to collect some information at specific timepoints at home. If you are eligible to enroll, you will receive a single injection of either the study medication or placebo. There will then be follow-up visits over the next 14 months (either in person or on the phone) to track laboratory and health measurements. The doctor’s office conducting the study will be able to provide you with more information about the study requirements.

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

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

Frequently Asked Questions (FAQs)

Will I get paid to be a part of this clinical trial?

Yes, you will be paid for your time. We realize it takes a lot of time to come for study visits and complete your health diary at home, so we want to make sure this is not too much of a burden for you. The study site will review all these details with you. Also, you do not have to pay anything to be in the study. All study related services are provided at no cost.

What if there is not a study site enrolling near me?

You may have the opportunity to participate in this study remotely. Please click this link to see if you qualify for remote participation.

Is there a possibility that I will receive placebo?

If eligible, you would be placed by random chance in a group to receive either ADG20 or placebo. The placebo looks like ADG20 but does not contain any active ingredients. This helps to determine if ADG20 is better at preventing or reducing the severity of symptoms of COVID-19 compared to not taking any medicine. The chance of you receiving ADG20 or placebo is the same. Neither you nor your study team will know which group you are in.

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 web page by clicking the ‘Get Started’ button.

What is a phase 2/3 clinical trial?

Phase II studies test treatments that have been found to be safe in earlier studies and now need a larger group of human subjects to monitor for any adverse effects as well as to test how well the investigational therapy works.

Phase III studies are conducted with a larger number of participants and in different regions and countries and are often the step right before a new treatment is approved.

The Phase 2 section of the study has already completed and is now enrolling interested and eligible participants in Phase 3.

Can I withdrawal from the study at any time?

Participation in the study is strictly voluntary. A participant has the right to withdraw from the study at any time and for any reason.

What personal information is collected about you for the study?

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

Your name, address, telephone number, health insurance number where applicable.
Your age, sex, ethnic and racial background.
Lifestyle information; health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples.

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

Who has access to your personal information?

All your personal information collected for this study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and 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 the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by Citeline Connect to contact you about clinical trials and related information.