Frequently Asked Questions (FAQs)
Who is conducting this research study?
Who is conducting this clinical trial?
This clinical trial is led by a research team at Vanderbilt University Medical Center and takes place at sites across the United States.
How is this study being funded?
This study is funded by the National Center for Translational Sciences through the National Institutes of Health.
What is convalescent plasma and where does it come from?
These patients have developed antibodies that help fight the virus. When they donate blood, the yellow plasma that contains the antibodies can be separate out. This plasma can be given to sick patients through an IV.
How is plasma collected?
Convalescent plasma is collected using a clean, one-time use needle and collection kit. An intravenous (IV) line is placed into the donor’s arm. Blood flows through that IV line to a special machine that separates the plasma from the blood. The donor’s blood is then returned to them along with some saline in the same needle it was drawn in. To learn more about plasma donation, visit Blood Assurance’s website.
How long does the plasma donation process last?
Plasma donation takes about 1 hour. However, this time can vary based on the height and weight of the donor and the speed of the blood separator machine.
Is plasma donation safe?
Yes. Plasma donation occurs in a safe and clean environment. Convalescent plasma is collected using a clean, single-use needle and collection kit. After each donation, the needle and kit are thrown away. Blood never comes in contact with the machine or leaves the kit. This protects donors from infection.
Who collects the plasma?
Vanderbilt University Medical Center works with Blood Assurance, a non-profit blood center that provides hospitals with a safe supply of blood and blood products. Blood Assurance is licensed by the Tennessee Department of Public Health and the U.S. Food and Drug Administration (FDA). They are approved to collect and process convalescent plasma for the Pass It On trial.
Cost to the participants
Does it cost money to take part in this study?
The treatment that you receive from the study will be paid for by the study. Any additional treatment that you receive outside of the study will be your responsibility.
Treatment and Risks
What are the risks of participating in this study?
Convalescent plasma has been used in the past to treat other viral infections, so the risk of using it should be small. This study has common risks related to blood draws and transfusions, and other risks that are rare but could be severe. If the study team sees any severe reactions during your transfusion, they will stop the treatment immediately for your protection. A full list of the risks can be found in the written consent form and the consent videos.
If you start to see that the treatment works, will you speed up the study?
A separate group of experts who monitor the safety of the trial will look at and analyze the data throughout the study. If they see that results are either promising or harmful, they will alert the study team.
How can I prepare for COVID-19?
While prevention is still the best way to protect yourself from becoming sick, you can begin preparing for COVID-19 by (1) making an emergency contact list, (2) identifying your local health care facility for COVID-19 testing and treatment, and (3) making sure you have any necessary items at home, such as hand sanitizer, disinfecting wipes, and face masks. To learn more about COVID-19, please visit the following sites:
What is a clinical trial and why are they important?
Clinical Trials, also called medical trials, are research studies that test new ways to prevent, screen for, diagnose, or treat disease. They are the main way that researchers find out if a new treatment, like a new medication, is safe and effective in people.
What will happen if I join the study?
Your participation will last for about 30 days. As part of the study, the researchers will collect information and samples from you to see how you are doing over time. You will give multiple samples of blood at different time points. Usually these samples can be taken from your IV line. The study team will also review information in your medical record such as your lab results. The study team will also follow up with you by phone after you leave the hospital. To pay you for your time on these calls, you will receive $25 on both Day 15 and Day 29.
How are participants protected?
If you decide to participate, your information will be protected under a Certificate of Confidentiality. This means the study team can protect your information and not release it even if requested for legal reasons. In addition, only the research team will have access to your protected health information.
Will I be told if I am receiving the plasma or the placebo?
This is a blinded, randomized controlled trial which means that you will be randomly placed into one of two groups: plasma treatment or placebo. The placebo is a water, salt, and vitamin solution with no plasma in it. You will not know which group you are in. Both groups are very important to the study to help researchers find out if plasma is better or worse than getting no plasma.
Am I eligible to join this study?
You may be eligible to join this study if you are 18 years or older and are hospitalized for COVID-19. You must meet the study’s eligibility criteria which are outlined in the full informed consent form.
When are patients able to join this study?
Adults who are hospitalized with COVID-19 will be approached about joining this study once they have been admitted into the hospital.
Can I join this study if I don’t speak English?
Yes! People from all backgrounds are encouraged to take part in this study. All study materials including the (1) informed consent forms, (2) video consents, and a (3) study website are translated into multiple languages including English, Spanish, Arabic, and Mandarin.
Can I participate in this study if I have a preexisting condition?
Individuals with preexisting conditions may be able to join this study. Please see the study’s informed consent form for a full list of eligibility criteria. You may also ask your doctor, nurse, or local study coordinator to see if you would be a good fit for the study.
Will results of the study be provided to me?
Once the study is completed, the researchers will share the study findings in a peer-reviewed journal article. A summary of the results will also be on ClinicalTrials.gov and this website.