COVID-19 TREATMENT STUDY

Frequently Asked Questions

Questions about this study

I don’t feel well and am worried I have coronavirus. Can the COVID-19 Treatment Study help me?

If you do not feel well contact your healthcare provider. The COVID-19 Treatment Study only enrolls participants who have had a laboratory-confirmed positive SARS-CoV-2 test in the last 72 hours and is not a replacement for clinical care.

I submitted my study application a while ago. Will I get a response?

All applications are carefully reviewed, and only those participants who may be eligible for the study will receive a response. If you have not received a response to your application within two days of submission, this indicates that your application has not fit with the current study needs and availability.

What about hydroxychloroquine and hydroxychloroquine/azithromycin? Wasn’t this study looking at those medications?

This study is designed to look at multiple different medications. Our first study medications were hydroxychloroquine and hydroxychloroquine + azithromycin. On July 27, 2020 we stopped enrolling participants into this study. This initial study had been designed to see if these medications prevented viral pneumonia, hospitalization and death. Fortunately, we had very few instances of these complications of COVID-19 in our study. However, this made it difficult for us to answer the question as designed. In addition, many well conducted randomized clinical trials were recently published that showed that HCQ and HCQ/azithromycin did not appear to change the course of infection in people with early or mild/moderate disease. For these reasons we stopped investigating these study medications. We are continuing to analyze the data from the many participants who enrolled in this study, and we will learn a lot from everyone’s participation.

Why are you using LPV/r to treat COVID-19?

Lopinavir/ritonavir (LPV/r) is a very widely prescribed antiviral medication with a well-known safety profile. LPV/r has activity against coronaviruses in the laboratory and in animal models. Studies of LPV/r in hospitalized patients with COVID-19 have not been effective, but we think that giving the medications earlier when patients are still well enough to be at home may be more effective to treat the virus.

Questions about safety

Is this study safe?

The Data and Safety Monitoring Board (DSMB) is an independent group of clinical research experts and patient advocates who monitor the progress of a clinical trial and review safety and effectiveness data while the trial is ongoing. The DSMB will monitor the study and it continues to ensure it is safe. More.

How do you monitor participant safety?

Safety is a key concern for this study. To ensure safety of all study participants, we monitor oxygen levels in the blood to help determine if viral pneumonia is developing. This can help determine when participants may need to seek care.

Other questions

I saw that the drug remdesivir can be used for coronavirus/COVID-19 treatment. Why aren’t you testing remdesivir in your study?

Remdesivir is an investigational broad-spectrum antiviral that is administered via daily infusion and is used to treat patients with severe COVID-19 who are admitted to the hospital. This study aims to test medications that can be administered orally at home.

Where can I find information on other related COVID-19 studies at the University of Washington?

Other research studies conducted by the University of Washington are currently looking for participants:
• The COVID-19 and Pets Study (CAPS) aims to learn more about the role animals play in the coronavirus outbreak. The study is enrolling residents of King County, Washington, who have a positive test result for COVID-19 within the last two weeks (either themselves or a member of their household), and have an animal in their household (dogs, cats, ferrets, hamsters). To learn more or enroll, click here.