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testing for PEP trial

Upstate seeks healthy people exposed to COVID-19 to participate in national study

Upstate Medical University is seeking healthy, symptom-free people who have had direct exposure to COVID-19 for a national study to test a drug to treat the disease.

Upstate’s Institute for Global Health and Translational Studies is one of seven sites nationwide participating in this COVID-19 post-exposure prophylaxis study. Good candidates for the study are likely living with someone who has tested positive for the disease but have not shown any symptoms themselves. Upstate is working to enroll 500 local participants, said Michelle Klick, LPN, CCRP, clinical research manager at the Institute for Global Health and Translational Studies.

Here’s how the study will work:

Potential participants must be 18 years old or older and must have had close personal contact with someone diagnosed with COVID-19. In many cases that means living with someone with COVID-19. Participants may also be healthcare workers if he or she was exposed for at least 10 minutes and was not wearing personal protective equipment. For the study to be effective, the participant must begin taking the medication within four days of exposure, Klick explained.

Interested parties may call Upstate at 315-464-9869 or email [email protected] to enroll. An Upstate staff person will conduct an over the phone interview to determine eligibility. Good candidates will then proceed to a 30-minute telemedicine conference with a doctor. That conversation will include discussion of potential side effects and what conditions might prevent a person from participating, Klick said.

Upon official enrollment, Upstate will deliver a box of supplies to the person’s home. The box includes medication, nasal swabs and directions.

The PEP study is a double-blind meaning participants will be taking either hydroxychloroquine (HCQ) or vitamin C. Neither the participant nor the Upstate study team will know what is given. Participants must take one dose every day for 14 days. Participants must also conduct a daily mid-nasal swab and fill out a brief, daily health questionnaire. Upstate will pick up the nasal swabs from the participant every five days and will monitor questionnaire responses should any health issues arise, Klick said.

Participants must conduct one more nasal swab and complete a final questionnaire again on the 28th day before their work is complete. Participants are compensated $100 after successfully completing the first 14 days and then again after the 28th day for a total of $200.   

Upstate has been screening and enrolling patients into the study for several weeks. Only this week did they also begin enrolling people who have tested positive for COVID-19. Those participants will not take medication but will conduct a nasal swab and fill out a questionnaire. 

The overall purpose of the study is to determine the effectiveness of hydroxychloroquine (HCQ), an anti-malarial drug that is being studied to see if it helps prevent or lessen symptoms of COVID-19. Kristopher Paolino, MD, is director of clinical research for the Institute for Global Health and Translational Medicine. He is also principal investigator for the study, which began at the University of Washington with support from the Bill & Melinda Gates Foundation.

“The purpose of this study is to better define what potential benefits there may be in using hydroxychloroquine as early in the disease process as possible following exposure,” Paolino said. “We hope to aid in collecting meaningful data to show whether or not taking this medication as early as possible could provide people with protection against developing COVID disease, or potentially shorten their illness duration if they are already COVID positive.”

Klick and her staff have been contacting family members of COVID-19 patients treated at Upstate to encourage them to participate in the study. The Institute for Global Health is also sharing information about the study with testing sites throughout Central New York in the hope of attracting additional participants. There is no limit to the number of participants allowed per household, she said. Upstate is relying on the community to help spread the word and encourage participation in order to better understand how this drug might help future patients.

“We do all kinds of research here related to infectious disease and global health. I feel like all the work our team does is very meaningful but this is more so because this is so real right now,” Klick said. “I’ve been a research coordinator for over 20 years and this feels like very meaningful work.”