Trial to assess hydroxychloroquine for COVID-19 prevention during cancer treatment
A randomized phase 2 clinical trial will assess hydroxychloroquine for prevention of COVID-19 infection among patients undergoing radiation therapy for cancer.
“Patients may be at a higher risk for contracting COVID-19 during cancer treatment due to increased exposure,” Nancy Y. Lee, MD, FASTRO, vice chairman and radiation oncologist in the department of radiation oncology at Memorial Sloan Kettering Cancer Center, said in a press release. “There is an urgent need to identify effective risk-reduction strategies for these patients who require treatment for their cancer as we await effective therapeutic options. This trial will provide important insight into the potential role that hydroxychloroquine might play in addressing this critical need.”
Lee spoke with Healio about what prompted this research, the timeline for results and potential implications of the findings.
Question: What is the rationale for this study?
Answer: Patients who undergo daily radiation following a cancer diagnosis have a higher risk for COVID-19 infection due to higher exposure rates. Hydroxychloroquine is used for the prevention and treatment of certain types of malaria, as well as rheumatoid arthritis, lupus and porphyria cutanea tarda, and is being evaluated in a variety of settings for its potential to prevent and treat COVID-19.
Q: How will you conduct the study?
A: This phase 2, randomized, double-blind, placebo-controlled study will be conducted across multiple centers. We will enroll patients aged 18 years and older who are undergoing radiation therapy alone or in combination with chemotherapy. Participants will be randomly assigned 1:1 to prophylactic hydroxychloroquine or placebo, and we will compare the likelihood of symptomatic COVID-19 infection between the hydroxychloroquine and placebo groups. We will also compare the likelihood of severe COVID-19 infection between study groups and evaluate acute toxicities associated with administration of hydroxychloroquine during radiation or chemoradiation.
Q: What do you expect to find?
A: We hypothesize that hydroxychloroquine will decrease the risk for COVID-19 infection by half, as there are preclinical data that show this rationale to be sound and that hydroxychloroquine can decrease risk.
Q: When do you anticipate completion of the study and when might data be available?
A: Completion of the study depends upon patient enrollment, but we hope to complete the trial within the next 3 to 6 months and have a data readout shortly thereafter.
Q: What will the impact be, if proven effective?
A: The potential impact is that patients can take hydroxychloroquine and expect a lower risk for COVID-19 infection during radiation treatment for cancer. This is important, as patients who are positive for COVID-19 and are undergoing cancer therapy do not do as well as those without COVID-19.
Q: Is there anything else that you would like to mention?
A: We are excited to conduct this study because it makes sense mechanistically. If we wait until patients are very sick with COVID-19 infection, hydroxychloroquine will have no effect, which is what we see in the current published trials. – by Jennifer Southall
For more information:
Nancy Y. Lee, MD, FASTRO, can be reached at Memorial Sloan Kettering Cancer Center, 633 Third Ave., 2nd Floor, New York, NY 10017; email: firstname.lastname@example.org.
Disclosure: Lee reports no relevant financial disclosures.