Researchers at the University of Maryland School of Medicine (UMSOM) have begun testing the effectiveness of hydroxychloroquine as a therapy to prevent infection and symptoms in individuals who have been exposed to COVID-19-positive individuals. The trial is significant because it focuses on preventing COVID-19 and does not involve individuals who are ill with infection but rather healthy individuals who have been exposed.
The research is part of a national study being conducted across the COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation (BMGF), Wellcome, and Mastercard, with funding from an array of public and philanthropic donors, to speed up the response to the COVID-19 pandemic by funding the identification, assessment, development, and scale-up of treatments.
Principal investigators for the COVID-19 Post-Exposure Prophylaxis (PEP) trial — which is being conducted remotely among volunteers throughout the Baltimore-Washington area — are Kathleen Neuzil, MD, MPH, the Myron M. Levine Professor in Vaccinology, professor of medicine and pediatrics, and director of the Center for Vaccine Development and Global Health (CVD), and Miriam Laufer, MD, MPH, professor of pediatrics and associate director of the CVD’s Malaria Research Program.
Neuzil and Laufer are infectious disease specialists with extensive experience in vaccine and infectious disease research. Laufer is a hydroxychloroquine expert, having spent years researching the therapy’s effectiveness in children, pregnant women, and people living with HIV, as well as the epidemiology of drug-resistant malaria.
“We know that many COVID-19-positive individuals have mild or no symptoms but are still very contagious. If we can prevent infection or symptoms in individuals who have been exposed to them, we can significantly alter the course of this pandemic,” Neuzil said.
“Our goal is to reach adult family and household members who live with someone who has recently been diagnosed with COVID-19,” Laufer said. “To be able to really see how to best protect these exposed individuals, we need to enroll as many people as we can into this study. We want to work with testing sites, public health facilities, medical practices, long-term care facilities, and hospitals to identify anyone who might be eligible. Most COVID-19 infection is transmitted within households, so we are working to protect the health of the individuals in the family and limit the broader spread of COVID-19 infection. This could serve as a critical preventative treatment.”
The research is critical as more than three-quarters of COVID-19 transmissions occur through close contact within households. The study is being conducted remotely through online video calls and by answering questions via email. Individuals who qualify for the randomized study will take hydroxychloroquine or a placebo daily for 14 days. Volunteers who participate in the study will be asked to take the medication, complete an online survey to assess their symptoms, and collect a sample by swabbing the inside of their nose every day for 14 days. On Day 28, a final swab will be collected and a survey completed.
“This research at the University of Maryland School of Medicine is critically important in understanding how we can prevent serious illness from COVID-19. Importantly, a preventative therapy would protect first responders and front-line workers in health facilities and elsewhere. If we can prevent COVID-19 infection, we can help reduce infection and mortality among our most vulnerable individuals,” said Dean E. Albert Reece, MD, PhD, MBA, who also is executive vice president for medical affairs, University of Maryland, Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor, UMSOM.
This research is part of a larger national study led by the University of Washington. This study is a randomized, multi-center study, enrolling nationwide up to 2,000 men and women who meet the eligibility criteria. For more information, visit www.covid19pepstudy.org.
“Our goal is to stop transmission of COVID-19 in the community,” said the multi-site study’s principal investigator, Ruanne Barnabas, MBChB, DPhil, associate professor of global health, University of Washington. “We currently don’t know if hydroxychloroquine works, but through this study we will learn in as short a time frame as possible whether hydroxychloroquine can prevent transmission in people exposed to the virus.”