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 COVID-19 in a reduced amount of time, avoiding the likelihood of hospitalization.
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. They can take more than six months to complete. Researchers monitor patients closely for harmful side effects. 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.
All studies within the CCRC will be based on science conducted by Fred Hutch faculty or generated by biotechnology & pharmaceutical companies. The studies will be implemented by Fred Hutch & University of Washington investigators with oversight by the Medical Director for the facility, Dr. Rachel Bender Ignacio.
Being in any clinical study may have some risks. There is a chance that the study medicine may cause side effects. There is also a chance that the medicine may not work, may not make you feel better, and/or may not stop you from getting sicker. The study teams will discuss the possible risks with possible participants prior to enrollment.
The benefits of the study medicine are not known, but there is a chance that it may work and you may feel better or stop from getting sicker. Even if you do not directly benefit from the study medicine, information learned from the study may help others who have COVID-19 and will help researchers understand more about treatment methods for COVID-19.
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.
If you still have questions after reading our FAQs, please contact us at firstname.lastname@example.org or call 206.667.7710.
If you have questions about COVID-19 symptoms or other pandemic-related questions, please visit the Centers for Disease Control and Prevention.
If you experience a medical emergency, call 911 and notify the operator if you think you might have COVID-19.