Antibodies: Proteins in the blood that might help fight the infection.
Blood infusion: A common, safe medical procedure in which healthy blood is given to you through an intravenous (IV) line that has been inserted in one of your blood vessels.
Clinical trial: A research study involving human volunteers (also called participants) that is intended to add to medical knowledge.
Convalescent Plasma: Convalescent plasma is the liquid part of blood that is collected from patients who have recovered from the novel coronavirus disease, COVID-19, caused by the virus SARS-CoV-2. COVID-19 patients develop antibodies in the blood that fight against the virus.
Double blinded study: A study where neither the participants nor the researchers know who is receiving a particular treatment. This procedure is used to help researchers learn which treatment option is best.
Eligibility criteria: The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria include both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating).
Enrollment: The number of participants in a clinical study. The “estimated” enrollment is the target number of participants that the researchers need for the study.
Exclusion criteria: A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study.
Inclusion criteria: A type of eligibility criteria. These are what is required for a person to participate in a study.
Informed consent form (ICF): The document used in the informed consent process.
Institutional Review Board (IRB): A group that protects the rights and wellbeing of people who are recruited and participate in research (human subjects research). An IRB reviews, monitors, and approves all human subjects research. The Pass It On trial has received IRB approval to conduct this study.
Pass it On: The Passive Immunity Trial for Our Nation
Placebo: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo. In the Pass It On trial, the placebo is a water fluid that contains salt and vitamins.
Principal Investigator (PI): The main person responsible for a clinical trial. The PI must agree to follow all laws and regulations for conducting medical research.
Randomization: In research, the process by which participants in a clinical trial are assigned by chance to separate groups that are given different treatments or other interventions. Neither the researcher nor the participant chooses which treatment or intervention the participant will receive.
Study Compensation: The amount of money that is provided to you as part of your participation in a research study.
Study Contact: The name and contact information for the person who can answer questions about a research study. Each location where the study is being done may have their own study contact.
Study Intervention/treatment: A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. In the Pass It On trial, the treatment being tested is convalescent plasma.
Study Sponsor: In the conduct of a clinical trial, a sponsor is an individual, institution, company or organization (for example, a contract research organization) that takes the responsibility to initiate, manage or finance the clinical trial, but does not actually conduct the investigation.
U.S. Food and Drug Administration (FDA): An agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other biological products, medical devices, the Nation’s food supply, cosmetics, dietary supplements, and products that give off radiation are safe, effective, and secure.