The Fred Hutch COVID-19 Clinical Research Center (CCRC) in South Lake Union of Seattle offers an opportunity for adults who are interested in investigational treatments and interventions for COVID-19, that can be safely administered and evaluated, to participate in studies in an outpatient setting. The studies will be implemented by Fred Hutch and University of Washington investigators with oversight by CCRC Medical Director, Dr. Rachel Bender Ignacio.
Discussing Study Details — The study team’s coordinator will receive and review the information you provided in the pre-screening call. They will confirm that initial criteria has been met for at least one of the studies, then call you to discuss:
- specifics for the study/studies qualified for, medication being tested, and the possible known benefits and risks
- the schedule for participation, including in-person visits, and the compensation for participation
- applicable study-specific follow-up questions that may need to be addressed to ensure eligibility to participate
Choosing to Volunteer — After considering the facts about the study and having your questions answered, if you decide you would like to proceed in participation the coordinator will schedule your initial appointment. Keep in mind, to remain eligible there may be a limited timeframe to schedule within.
Initial Appointment — Typically includes completing surveys and forms to confirm participation, discussing your medical history, having a physical exam and vital signs checked, having a blood draw for lab tests, and having a nasal swab test performed.
Initial Infusion / Baseline Appointment — Typically includes vital sign check, blood draw, and first IV infusion or baseline administration of the medication/placebo with monitoring after. The initial infusion or baseline visit is sometimes combined with the initial medical evaluation & consent.
Follow-up Appointments — Typically includes vital sign checks, blood draw, and discussion of your symptoms and medical progress. For some studies there are additional IV infusions or administrations of the medication/placebo with monitoring after.
Follow-up Surveys & Calls — Some studies will have online surveys to complete throughout participation, that do not require coming in-person to the CCRC. You may also receive check-in calls throughout participation. These check-in calls and short surveys typically help the study team in monitoring your health.
Facility Safety: The CCRC is designed for participants that are COVID-positive and those that are healthy or fully recovered from COVID to be within the facility, while protecting everyone from transmission. The facility includes dedicated air handling & circulation equipment with HEPA filters for each enclosed room. Extensive cleaning & disinfecting protocols are followed and all appropriate personal protective equipment for staff & participants is utilized. Entry points and areas of use are separated, with clear signage and wayfinding established throughout campus and online for reference. Coming to the CCRC to participate in a study falls within quarantine guidelines when adhering to the practices we have established.
Your Information: 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. We will not share participant’s private health or citizenship information, Social Security information is not needed, and Health Insurance is not needed or charged.
Your Health: During participation your health will be closely monitored, and care adjusted if the study team determines that it is in your best interest.
Participant Diversity: Our studies are inclusive of adult participants of diverse races, ethnicities, and backgrounds to help researchers understand the best treatment medicines and methods across diverse populations.
Compensation: Compensation for participation is available and varies by study. The study team’s coordinator will provide the compensation information. The study drug or placebo used in the study will be given to you at no charge. All study visits and fees for lab tests and procedures that are part of the study will be provided at no cost to you.
Transportation: We have complimentary, safe, private transportation to the center available that can be arranged by the study team prior to your visit.
Randomized, Double-blind, Placebo-controlled Clinical Trials: The CCRC studies are randomized, double-blind, placebo-controlled clinical trials. If you agree to take part in the study and meet the requirements, you will be randomized to receive the medication or placebo and cannot choose.
Benefits: If participants receive the medication being tested, it may help treat their COVID-19. 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. If you take part in the study, your health will be monitored closely.
Risks: 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.
Voluntary Participation: You have been asked to take part in a clinical research study and your decision to take part in a study is voluntary. 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 giving a reason.
COVID-19 Clinical Research Center
206.667.7100 | email@example.com
Resolve and Regeneron Study Team’s Research Coordinator Taylor Zimmerman: 206.667.2237 | firstname.lastname@example.org
Merck Study Team’s Research Coordinator Marta Levkova: 206.667.6807 | email@example.com
If you speak Spanish, please call 206.667.7100 or 206.667.2237 and and let us know the language you prefer to speak. We will have an interpreter join the call to assist after a brief hold.