Study Participant Information

Prophylaxis: the goal of prophylaxis-based research is to prevent the development of the infection, This is especially important for participants who may be at high risk, such as residing or working within a high-exposure area, or because of medical conditions that may compromise their immune system.

Therapeutic: the aim of therapeutic studies is to determine the best methods to decrease infection duration and/or alleviate symptoms that may occur during the infection or for the months following infection. This includes research on active COVID-19 infections, as well as post-acute (long-haul) COVID-19.

Observation: observational studies are research where the study teams track participants prior-to, during, and/or after infection to better understand the virus. No medications or drugs are utilized.

In therapeutic/treatment clinical studies, participants are given different investigational medicines that can be safely administered and evaluated. Through the testing of the different investigational medicines in randomized, double-blind, placebo-controlled studies, our study teams hope to be able to determine the most effective methods to treat & prevent COVID-19-related infection & symptoms. 

There will be multiple studies that are in different phases of their research. The different phases that a study can be in are designed to answer different research questions for effectiveness and safety throughout, in the effort to having effective treatment methods move through all the needed processes for final approvals.

Phase 1: Is it safe?
Phase 1 clinical trials show if an experimental drug is safe in a small population of humans and measures how their systems respond to it. Phase 1 is typically the first time this treatment method is either tested in humans or applied for a given disease and can take more than six months to complete. Researchers monitor patients closely for harmful side effects to evaluate the overall safety and dosage of the treatment, and while not designed to see if the experimental drug works, such trials may give us early hints.

Phase 2: Is it working?
Phase 2 trials show whether the experimental drug is effective. Enrolling hundreds, they provide detailed data on the body’s response at different dosages in people of different ages and health status.

Phase 3: Can it do the job?
Phase 3 trials show whether an experimental drug can protect individuals on a large scale in a community. These studies must be large enough to prove that the experimental drug reduces the risk of spread of the illness. In Phase 3, the new treatment method is often compared to the standard treatment to determine if it is more effective, and participants are randomized, meaning they are randomly assigned to receive either the new treatment method, or the standard/a placebo.

Randomization is the process by which the study team randomly assigns participants to receive either the novel intervention or a placebo. Randomization, used in some Phase II and nearly all Phase III studies, is important to the scientific validity of the research. It eliminates bias in selecting which patients get which treatment. This helps ensure that differences between the groups’ results are due to the different treatments they received and not other factors. Often, randomized studies are double blind, meaning neither you nor your doctor knows whether you’ve received the treatment or placebo.

There may be restrictions on the medications that you can take during the study. Please make sure to tell your study doctor or study nurse all medications that you are currently taking or want to start taking. There may be side effects that are not known or happen rarely when participants take study drugs. Having a blood sample taken from a vein may cause pain, bruising, lightheadedness, fainting, and very rarely, infection at the site of the needle stick. There is a risk of an infusion reaction associated with administration of a drug via infusion into a vein. Allergic reactions are always possible with a drug that you have not taken before. You will be told of any new information that might cause you to change your mind about continuing participation in the study. Review all the information provided by the study team prior to consent and talk to your study doctor for details on possible side effects.

If participants receive the medication being tested, it may help treat COVID-19 infection/symptoms or help prevent symptomatic COVID-19 infection.  However, we do not know if this will happen. Participants may not get any benefit from taking part in the study. Your taking part in the study may help us know more about how to treat people with COVID-19 and/or prevent COVID-19 infection. If you take part in the study, your health will be monitored closely.

Informed consent is an agreement that the participant will be well informed of all study details before beginning participation. Before entering the study, the research coordinator will discuss all parts of the study, including time commitment, compensation, benefits, side effects and risks. At any time during the research process, the participant has the right to ask any questions to the study team to ensure they fully understand the study and their participation.

The CCRC’s design is geared specifically to be able to safely treat both COVID-positive participants and those that are healthy or have fully recovered from COVID-19, while protecting everyone from transmission. The retro-fit of the CCRC facility included the implementation of new air circulation equipment keeping COVID-19 needs in mind, with dedicated air handling & circulation and HEPA filters for each enclosed room, that all well exceeds the standards seen in medical facilities. We have ensured that extensive cleaning and disinfecting protocols are followed, and that staff and participants are utilizing the appropriate personal protective equipment.

We know that our participant’s time is valuable. If you qualify and decide to join a COVID-19 treatment study, you will be compensated for your time. The study team will outline the full payment schedule prior to the participant enrolling.

Fred Hutch is diligent about upholding the internationally recognized codes of ethics and applicable laws & regulations, to ensure the protection and confidentiality of all study participants. The CCRC and its study teams will not share participant’s private health information or citizenship information at any point and social security information is not needed to participate.

Health Insurance is not needed to participate, and you do not need to provide insurance information to the study team. We do not charge for participation to either the participant or to their health insurance company.

We recognize that getting to the CCRC in South Lake Union area may not be easily accomplished when you are also feeling ill. We do have private & safe transportation to the center available, at no charge to the participant, that can be arranged with our study teams at the time of screening. The CCRC has been designed to keep participants within the quarantine guidelines so that they can safely participate and we can protect others from transmission.

Being in a study at the CCRC is voluntary and you do not have to join. The study team will provide a detailed schedule to review and consider prior to consent. You can refuse to take part or stop taking part at any time, without providing a reason.