Intermountain researchers have launched several clinical trials related to COVID-19, including trials evaluating the effectiveness of the drug hydroxychloroquine in treating COVID-19. Here are some answers to common questions about our hydroxychloroquine clinical trials.
How does Intermountain provide access to hydroxychloroquine for patients who might need it? Prior to launching Intermountain’s hydroxychloroquine COVID-19 clinical trials, research and pharmacy leaders — in consultation with clinical leaders — established priorities to maintain access to hydroxychloroquine for patients with chronic conditions, such as lupus and rheumatoid arthritis, for which this treatment is well proven and FDA approved.
Intermountain’s prioritized access to hydroxychloroquine:
- Patients with chronic conditions including lupus and rheumatoid arthritis, for which the treatment is well proven and FDA approved
- Participants of the inpatient COVID-19 study assessing if the drug may save lives
- Participants of the outpatient COVID-19 study assessing if the drug reduces hospitalizations
“We haven’t had any supply issues with hydroxychloroquine and have been able to meet the needs of our patients with lupus and rheumatoid arthritis as well as supply the medication for the studies,” says Sabrina Cole, executive operations director of pharmacy services.
What is Intermountain’s approach to treatment for COVID-19, and specifically treatments publicized in the media? Best-practice supportive care remains the most important management approach for patients with severe COVID-19 who require hospitalization. Clinical trials enable the best environment for providing access to investigational treatments, including medications already FDA approved for non-COVID use and also being used “off label” for COVID-19 as is the case for hydroxychloroquine and other therapies.
“Clinical trials not only help us learn whether a treatment actually works, but also are designed to ensure participants are as safe as possible and their rights are carefully protected,” says Raj Srivastava, MD, Intermountain’s associate vice president of research. “Since the start of the pandemic, more than 50 percent of patients hospitalized with COVID-19 at Intermountain have received a treatment through a trial or expanded access program.”
What is the science behind why hydroxychloroquine might help? Therapeutic approaches to treating COVID-19 can be categorized as either virologic or immunologic. A virologic therapy focuses on how the coronavirus works, and in the case of hydroxychloroquine, the drug aims to keep the virus from entering the cell by changing the pH of the cell component called an endosome. Endosomes transport the virus across the cell membrane and into the cell.
Immunologic therapies focus on how the patient’s body responds to the virus. There’s evidence that the patient’s own immune overresponse is what harms some of the sickest patients with COVID-19.
What safety precautions are we taking for hydroxychloroquine trials?
- Patients are carefully screened to ensure they don’t have risk factors that may increase side-effects of hydroxychloroquine.
- Enrolled participants are monitored every day for any early indicators of side effects from the medications.
- Study physicians are available to address any concerns raised by the participants or research coordinators.
By following these procedures, study physicians and staff have been able to mitigate potential risks before they occur and ensure study medications are being prescribed in a safe way.
Intermountain has been aligned with FDA guidance since the beginning of the pandemic. Trial investigators received approval from the FDA to conduct these studies and remain confident they are designed to best protect the safety of participants.