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Implementation of a fully remote randomized clinical trial with cardiac monitoring

2021; Nature Portfolio; Volume: 1; Issue: 1 Linguagem: Inglês

10.1038/s43856-021-00052-w

2730-664X

Jacob J. Mayfield, Neal A. Chatterjee, Peter A. Noseworthy, Jeanne E. Poole, Michael J. Ackerman, Jenell Stewart, Patricia Kissinger, John Dwyer, Sybil Hosek, Temitope Oyedele, Michael K. Paasche‐Orlow, Kristopher Paolino, Paul A. Friedman, Chloe Waters, Jessica Moreno, Hannah Leingang, Kate B. Heller, Susan Morrison, Meighan Krows, Ruanne V. Barnabas, Jared M. Baeten, Christine Johnston, Medhavi Bole, Alyssa Braun, Helen Y. Chu, Mark W. Drummond, Kirsten Hauge, Madelaine Humphreys, Abir Hussein, Christine Johnston, Steve Kuntz, Anya Mathur, Lindsey McClellan, Jessica Moreno, Thepthara Pholsena, Matthew Seymour, Helen C. Stankiewicz Karita, Jenell Stewart, Jina M Taub, Zoe Thuesmunn, Ethan Valinetz, Dana Varon, Anna Wald, Brian Wood, Maianna Dematteis, Katie Wicklander, Rebecca Letterer, Jeanne E. Poole, Arun Raghav Mahankali Sridhar, Jeff Purcell, Mary Ellen Kirk, Chloe Waters, Jared M. Baeten, Ruanne V. Barnabas, Jennifer Baugh, Clare Brown, Connie Celum, Daphne Hamilton, Harald S. Haugen, Rachel Johnson, Jack Knauer, Caroline H. Liou, Susan Morrison, Justice Quame‐Amaglo, Azaad, Randy M. Stalter, Jenell Stewart, Katherine K. Thomas, Vianey Vázquez, Grant E. Young, Yasaman Zia, Azaad Zimmermann, Meei‐Li Huang, Alexander L. Greninger, Keith R. Jerome, Mark H. Wener, Deborah J. Brown, Nathaniel Davenport, Omar Gambito, Luisa Arroyave, Agata Bereznicka, Jonathan P. B. Berz, P Buitrón, Michael Camuso, Leticia Cardoso, Ricardo Cruz, Julien Dedier, Husam Dennaoui, Anna L. Goldman, Lori Henault, Terrell K. Johnson, Sarah Koberna, Carlie Martinez, Erin Martinez, Crystal Ng, Michael K. Paasche‐Orlow, Margot Rogers, Kathleen Salerno, Carl G. Streed, Ve Truong, Nisha Verma, Katherine Waite, Steven Zalewski, Elizabeth R. Brown, Tracy Qi Dong, Joshua T. Schiffer, C.H. Balthazar, Kelly Bojan, Hamid Bouiri, Marisol Consignado, Kortez Davis, Sadhana Dharmapuri, M. Ceballos González, Sybil Hosek, Rachel Jackson, Meenakshi Malhotra, Antionette McFadden-Smith, Raymond McPherson, Ryan Muench, Ixchell Oritz-Estes, Temitope Oyedele, Dorothy Rego, Zoe Ellen Sanders, Alisa Seo-Lee, Karen H Simpson, Michael J. Ackerman, Zachi I. Attia, Peter A. Noseworthy, Stefanie Bendik, Anna Bershteyn, Robert Pitts, Peter Greco, Michelle Klick, Kristopher Paolino, Mueenah Anibaba, Evan Atkinson, Mary Beth Campbell, Gérard Gomes, Jacob A. Hall, John Huntwork, Margaret Huntwork, Patricia Kissinger, Heather Larkin, Cedrick Ntambwe, Florice K Numbi, Michelle Paloomares, Norine Schmidt, Hamada Rady, Maria Ribando, Daniel Triggs, Neha Upadhyay, Crystal Zheng, Arun Raghav Mahankali Sridhar,

COVID-19 Clinical Research Studies

Abstract Background The coronavirus disease 2019 (COVID-19) pandemic has challenged researchers performing clinical trials to develop innovative approaches to mitigate infectious risk while maintaining rigorous safety monitoring. Methods In this report we describe the implementation of a novel exclusively remote randomized clinical trial (ClinicalTrials.gov NCT04354428) of hydroxychloroquine and azithromycin for the treatment of the SARS-CoV-2–mediated COVID-19 disease which included cardiovascular safety monitoring. All study activities were conducted remotely. Self-collected vital signs (temperature, respiratory rate, heart rate, and oxygen saturation) and electrocardiographic (ECG) measurements were transmitted digitally to investigators while mid-nasal swabs for SARS-CoV-2 testing were shipped. ECG collection relied on a consumer device (KardiaMobile 6L, AliveCor Inc.) that recorded and transmitted six-lead ECGs via participants’ internet-enabled devices to a central core laboratory, which measured and reported QTc intervals that were then used to monitor safety. Results Two hundred and thirty-one participants uploaded 3245 ECGs. Mean daily adherence to the ECG protocol was 85.2% and was similar to the survey and mid-nasal swab elements of the study. Adherence rates did not differ by age or sex assigned at birth and were high across all reported race and ethnicities. QTc prolongation meeting criteria for an adverse event occurred in 28 (12.1%) participants, with 2 occurring in the placebo group, 19 in the hydroxychloroquine group, and 7 in the hydroxychloroquine + azithromycin group. Conclusions Our report demonstrates that digital health technologies can be leveraged to conduct rigorous, safe, and entirely remote clinical trials.