Rush University Medical Center has opened enrollment for a new clinical trial investigating whether the drug hydroxychloroquine is better than a placebo in preventing COVID-19 infection in healthy people working in health care settings.
The Healthcare Worker Exposure Response & Outcomes of Hydroxychloroquine (HERO-HCQ) Trial will enroll 15,000 people from the HERO Registry, an online community of thousands of people working in health care, which supports this and future trials.
The study will randomize participants to receive either one month of hydroxychloroquine or one month of a placebo to examine whether the drug is effective in preventing COVID-19.
"The HERO Registry provides a virtual community of health care workers that can help us better understand their health outcomes and experiences, and prioritize unmet health care worker needs," said Dr. Yoona Rhee, assistant professor of infectious diseases and the primary investigator of the study at Rush University Medical Center.
The HERO-HCQ is the first trial to be offered from this registry.
There is a lot of interest in testing this drug as a preventive agent for COVID-19, because it appeared to block SARS-CoV-2 (the virus that causes COVID-19) from entering cells in lab studies."
Susanna Naggie, Associate Professor, Department of Medicine, Duke University School of Medicine
Naggie is also the principal investigator for the HERO-HCQ Trial.
"But like all medications, there are potential risks as well as benefits. Before we can make recommendations on using hydroxychloroquine to prevent COVID-19, we need solid evidence, and the HERO-HCQ trial will help provide this data to guide decision-making."
Researchers at Rush plan to recruit at least 375 people into the study. All people working in health care settings who provide care, supplies, or services to patients at Rush University Medical Center and Rush Oak Park Hospital -- such as nurses, therapists, physicians, emergency responders, food service workers, environmental services workers, interpreters and transporters -- are invited to first join the HERO Registry to determine their interest in the HERO-HCQ Trial.
To participate in the study, when they sign up for the registry health care workers must answer "yes" to a question determining interest in being contacted about participation in a randomized clinical trial of hydroxychloroquine.
"Health care workers remain at risk of infection with the COVID-19 virus."
"High-quality studies of health care workers are imperative to understand whether preventive therapy can help reduce their risk of developing COVID-19," Rhee said.
"The HERO-HCQ trial seeks to answer that question -- whether hydroxychloroquine can help prevent these health care workers from acquiring COVID-19."
Hydroxychloroquine is an oral prescription medication approved by the US Food and Drug Administration for the treatment of malaria and autoimmune diseases such as lupus and arthritis.
Study participants will receive nasal swab tests for COVID-19 and blood tests to detect the presence of COVID-19 virus antibodies at the beginning of the study and after four weeks.
Researchers also will collect information about participants' health and ask them to fill out quality-of-life surveys.
Unlike typical studies that take months to collect and analyze data, researchers will analyze data from the study every two weeks.
"As soon as we have evidence of the effectiveness of the drug, the lead investigators will conclude the trial and make a recommendation based on whether it proves to be a beneficial preventative therapy," Rhee said.
Researchers at the Duke Clinical Research Institute designed and are coordinating the HERO-HCQ Trial. The study is being conducted through clinical research sites in PCORnet, the Patient-Centered Outcomes Research Institute, which is providing up to $50 million in funding.