Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial

Ruanne V Barnabas, Elizabeth R Brown, Anna Bershteyn, Helen C Stankiewicz Karita, Christine Johnston, Lorna E Thorpe, Angelica Kottkamp, Kathleen M Neuzil, Miriam K Laufer, Meagan Deming, Michael K Paasche-Orlow, Patricia J Kissinger, Alfred Luk, Kristopher Paolino, Raphael J Landovitz, Risa Hoffman, Torin T Schaafsma, Meighan L Krows, Katherine K Thomas, Susan Morrison, Harald S Haugen, Lara Kidoguchi, Mark Wener, Alexander L Greninger, Meei-Li Huang, Keith R Jerome, Anna Wald, Connie Celum, Helen Y Chu, Jared M Baeten, Hydroxychloroquine COVID-19 PEP Study Team, Peter Dull, Scott Miller, Thy Pham, Luisa Arroyave, Jonathan Berz, Pablo Buitron, Michael Camuso, Leticia Cardoso, Ricardo Cruz, Julien Dedier, Husam Dennaoui, Anna Goldman, Cheryl Greenstein, Lori Henault, Terrell Johnson, Sarah Kimball, Carlie Martinez, Erin Martinez, Crystal Ng, William Paarz, Qausarat Ogunneye, Lev Paasche‐Orlow, Margot Rogers, Kathleen Salerno, Michael Smithline, Carl Streed, Nisha Verma, Katherine Waite, Sybil Hosek, Christopher Balthazar, Anne Jarris, Leslie Anna Greene, Diana Buist, Sandra India Aldana, Marissa Alsaloum, Elle Anastasiou, Rodrigo Arce Cardozo, Beita Badiei, Kamilla Bakirova, Zulfiya Bakirova, Caroline Barnes, Sukhleen K Bedi, Dia B Beggs, Stefanie E Bendik, Meng Cao, Michelle Chang, Shirley Chen, Anna Cheng, Stella K Chong, Jane Coates, Sarah Conderino, Jacqueline Connery, Megan Connolly, Aira L Contreras, Matthew S Dreier, Emily Duan, Eveline Teresa Hidalgo, Maja Fadzan, Samantha N Fagan, Jamie Fried, Juan Gago, Nadia Gakou, Emily Gill, Akash Gujral, Xiaolei Hao, Christina Hughes, Robert T James, Sean Kim, Penina Krieger, Susan N Landon, Alice Li Juan Liang, Priscilla M Lopez, Lia Mamistvalova, Mark D Schwartz, Saydee McQuay, Wei William Miao, Sadia Mohaimin, Kaicy Gabriela Naranjo, Krissy Nguyen‐Stone, Ashley Peltekci, Andrea Peña, Katherine Perdomo, Mary Lou Pompeii, Lindsey Quintana, Amanda J Reynolds, Robert A Pitts, Andrea Rodriguez, Prabhu Sasankan, Sneha R Sharma, Amy Shire, Stela Sota, Ben R Spoer, Bethany Springer, Jay Stadelman, Christina B Wysota, Jackie Yang, Myriam Yepez, Danielle Cram, Stephen Eustace, Kathleen Mandziuk, Michael Massaro, Colleen Mullenix, Toze Reichard, Tiara Towner, Mark Abbott, Elizabeth Asiago‐Reddy, Kristen Baxter, Kate Caiello, Timothy Endy, Ivayla Geneva, Peter Greco, Elizabeth Harausz, Michelle Klick, Patrick Mehlek, Christopher Miller, Melissa Reale, Kianna Ripich, Andrea Shaw, Keely Terrillion, Stephen Thomas, Mueenah Anibaba, Evan Atkinson, Michelle Blyth, Mary Beth Campbell, Lillianna Carsch, Ashita Ganguly, Sarina Gupta, Heather Larkin, Jake Hall, John Huntwork, Margaret Huntwork, Mariel McConville, April McDougal, Florice Numbi, Cedrick Ntambwe, Michelle Palomares, Demetrius Plaxico, Hamada Rady, Maria Ribando, Sydney Sauter, Daniel Triggs, Neha Upadhyay, Norine Schmidt, Shannon Watson, Crystal Zheng, Rubi Arias, Azra J Bhimani, Cherie Blair, Catie Cambou, Meilani Cayabyab, Rafael Corona, Danielle Escobedo, Daisuke Furukawa, Amanda Gonzalez, Heather Karpf, Ryan Kofron, Karla Largaespada, Nancy Lopez, Hannah Mansky, Rachel Martin‐Blais, Antonia Petreuse, Christina Shin, Tran T Tran, Ameila Weldon, Gabriela Were, Vaidehi Agrawal, Melissa Billington, Megan Birkhold, Colleen Boyce, Marianne Cloeren, Carlo Foppinao Palacios, DeAnna Friedman‐Klabanoff, Alyson Kwon, Hanna LeBuhn, Esther Liu, Meredith Lu, Melissa McDiarmid, Melissa Myers, Faith Pa'ahana‐Brown, Marian Poley, Biraj Shrestha, Gentry Wilkerson, Nathan Alidina, Samuel Arnold, Marie Bauer, Jennifer Baugh, Cara Bayer, Medhavi Bole, Elizabeth Brandstetter, Alyssa Braun, Clare E Brown, Maxwell Brown, Michelle Bulterys, Jared Castor, Maianna Dematteis, Ivy Doan, Mark Drummond, Erika Feutz, Sean Galagan, Daphne Hamilton, Kirsten Hauge, Elsa Hay, Florian Hladik, Xuanlin Hou, Doug Houston, Madelaine Humphreys, Abir Hussein, Matthew Ikuma, Rodal Issema, Rachel Johnson, Mary Kirk, Jack Knauer, Steven R Kuntz, Savannah Lawton, Rebecca Letterer, Elina Lingappa, Jairam R Lingappa, Caroline H Liou, Katie Lund, Toni Maddox, Anya Mathur, Mari Metter, Lindsey McClellan, Deidra Montoya, Jessica C Moreno, Gregory C Morlin, Urvashi Pandey, Gregory Pepper, Alicia Pettit, Thepthara Pholsena, Griffin Popp, Jeff Purcell, Justice Quame‐Amaglo, Reigran Sampoleo, Elliott Sanger, Matthew Seymour, Alexander Shercliffe, Shabir Somani, Jenell C Stewart, Selorm Tamakole, Jina M Taub, Zoe Thuesmunn, Amena Tungara, Ethan Valinetz, Dana L Varon, Viany Vazquez, Bao‐Chau Vo, Valentine Wanga, Chloe D Waters, Yulun Wei, Meagan Welsh, Katie Wicklander, Brian R Wood, Grant Young, Zohdi Young, Lucy Zhao, Azaad Zimmermann, Deborah J Brown, Nathaniel Davenport, Omar Gambito, Ruanne V Barnabas, Elizabeth R Brown, Anna Bershteyn, Helen C Stankiewicz Karita, Christine Johnston, Lorna E Thorpe, Angelica Kottkamp, Kathleen M Neuzil, Miriam K Laufer, Meagan Deming, Michael K Paasche-Orlow, Patricia J Kissinger, Alfred Luk, Kristopher Paolino, Raphael J Landovitz, Risa Hoffman, Torin T Schaafsma, Meighan L Krows, Katherine K Thomas, Susan Morrison, Harald S Haugen, Lara Kidoguchi, Mark Wener, Alexander L Greninger, Meei-Li Huang, Keith R Jerome, Anna Wald, Connie Celum, Helen Y Chu, Jared M Baeten, Hydroxychloroquine COVID-19 PEP Study Team, Peter Dull, Scott Miller, Thy Pham, Luisa Arroyave, Jonathan Berz, Pablo Buitron, Michael Camuso, Leticia Cardoso, Ricardo Cruz, Julien Dedier, Husam Dennaoui, Anna Goldman, Cheryl Greenstein, Lori Henault, Terrell Johnson, Sarah Kimball, Carlie Martinez, Erin Martinez, Crystal Ng, William Paarz, Qausarat Ogunneye, Lev Paasche‐Orlow, Margot Rogers, Kathleen Salerno, Michael Smithline, Carl Streed, Nisha Verma, Katherine Waite, Sybil Hosek, Christopher Balthazar, Anne Jarris, Leslie Anna Greene, Diana Buist, Sandra India Aldana, Marissa Alsaloum, Elle Anastasiou, Rodrigo Arce Cardozo, Beita Badiei, Kamilla Bakirova, Zulfiya Bakirova, Caroline Barnes, Sukhleen K Bedi, Dia B Beggs, Stefanie E Bendik, Meng Cao, Michelle Chang, Shirley Chen, Anna Cheng, Stella K Chong, Jane Coates, Sarah Conderino, Jacqueline Connery, Megan Connolly, Aira L Contreras, Matthew S Dreier, Emily Duan, Eveline Teresa Hidalgo, Maja Fadzan, Samantha N Fagan, Jamie Fried, Juan Gago, Nadia Gakou, Emily Gill, Akash Gujral, Xiaolei Hao, Christina Hughes, Robert T James, Sean Kim, Penina Krieger, Susan N Landon, Alice Li Juan Liang, Priscilla M Lopez, Lia Mamistvalova, Mark D Schwartz, Saydee McQuay, Wei William Miao, Sadia Mohaimin, Kaicy Gabriela Naranjo, Krissy Nguyen‐Stone, Ashley Peltekci, Andrea Peña, Katherine Perdomo, Mary Lou Pompeii, Lindsey Quintana, Amanda J Reynolds, Robert A Pitts, Andrea Rodriguez, Prabhu Sasankan, Sneha R Sharma, Amy Shire, Stela Sota, Ben R Spoer, Bethany Springer, Jay Stadelman, Christina B Wysota, Jackie Yang, Myriam Yepez, Danielle Cram, Stephen Eustace, Kathleen Mandziuk, Michael Massaro, Colleen Mullenix, Toze Reichard, Tiara Towner, Mark Abbott, Elizabeth Asiago‐Reddy, Kristen Baxter, Kate Caiello, Timothy Endy, Ivayla Geneva, Peter Greco, Elizabeth Harausz, Michelle Klick, Patrick Mehlek, Christopher Miller, Melissa Reale, Kianna Ripich, Andrea Shaw, Keely Terrillion, Stephen Thomas, Mueenah Anibaba, Evan Atkinson, Michelle Blyth, Mary Beth Campbell, Lillianna Carsch, Ashita Ganguly, Sarina Gupta, Heather Larkin, Jake Hall, John Huntwork, Margaret Huntwork, Mariel McConville, April McDougal, Florice Numbi, Cedrick Ntambwe, Michelle Palomares, Demetrius Plaxico, Hamada Rady, Maria Ribando, Sydney Sauter, Daniel Triggs, Neha Upadhyay, Norine Schmidt, Shannon Watson, Crystal Zheng, Rubi Arias, Azra J Bhimani, Cherie Blair, Catie Cambou, Meilani Cayabyab, Rafael Corona, Danielle Escobedo, Daisuke Furukawa, Amanda Gonzalez, Heather Karpf, Ryan Kofron, Karla Largaespada, Nancy Lopez, Hannah Mansky, Rachel Martin‐Blais, Antonia Petreuse, Christina Shin, Tran T Tran, Ameila Weldon, Gabriela Were, Vaidehi Agrawal, Melissa Billington, Megan Birkhold, Colleen Boyce, Marianne Cloeren, Carlo Foppinao Palacios, DeAnna Friedman‐Klabanoff, Alyson Kwon, Hanna LeBuhn, Esther Liu, Meredith Lu, Melissa McDiarmid, Melissa Myers, Faith Pa'ahana‐Brown, Marian Poley, Biraj Shrestha, Gentry Wilkerson, Nathan Alidina, Samuel Arnold, Marie Bauer, Jennifer Baugh, Cara Bayer, Medhavi Bole, Elizabeth Brandstetter, Alyssa Braun, Clare E Brown, Maxwell Brown, Michelle Bulterys, Jared Castor, Maianna Dematteis, Ivy Doan, Mark Drummond, Erika Feutz, Sean Galagan, Daphne Hamilton, Kirsten Hauge, Elsa Hay, Florian Hladik, Xuanlin Hou, Doug Houston, Madelaine Humphreys, Abir Hussein, Matthew Ikuma, Rodal Issema, Rachel Johnson, Mary Kirk, Jack Knauer, Steven R Kuntz, Savannah Lawton, Rebecca Letterer, Elina Lingappa, Jairam R Lingappa, Caroline H Liou, Katie Lund, Toni Maddox, Anya Mathur, Mari Metter, Lindsey McClellan, Deidra Montoya, Jessica C Moreno, Gregory C Morlin, Urvashi Pandey, Gregory Pepper, Alicia Pettit, Thepthara Pholsena, Griffin Popp, Jeff Purcell, Justice Quame‐Amaglo, Reigran Sampoleo, Elliott Sanger, Matthew Seymour, Alexander Shercliffe, Shabir Somani, Jenell C Stewart, Selorm Tamakole, Jina M Taub, Zoe Thuesmunn, Amena Tungara, Ethan Valinetz, Dana L Varon, Viany Vazquez, Bao‐Chau Vo, Valentine Wanga, Chloe D Waters, Yulun Wei, Meagan Welsh, Katie Wicklander, Brian R Wood, Grant Young, Zohdi Young, Lucy Zhao, Azaad Zimmermann, Deborah J Brown, Nathaniel Davenport, Omar Gambito

Abstract

Background: Effective prevention against coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is currently limited to nonpharmaceutical strategies. Laboratory and observational data suggested that hydroxychloroquine had biological activity against SARS-CoV-2, potentially permitting its use for prevention.

Objective: To test hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection.

Design: Household-randomized, double-blind, controlled trial of hydroxychloroquine postexposure prophylaxis. (ClinicalTrials.gov: NCT04328961).

Setting: National U.S. multicenter study.

Participants: Close contacts recently exposed (<96 hours) to persons with diagnosed SARS-CoV-2 infection.

Intervention: Hydroxychloroquine (400 mg/d for 3 days followed by 200 mg/d for 11 days) or ascorbic acid (500 mg/d followed by 250 mg/d) as a placebo-equivalent control.

Measurements: Participants self-collected mid-turbinate swabs daily (days 1 to 14) for SARS-CoV-2 polymerase chain reaction (PCR) testing. The primary outcome was PCR-confirmed incident SARS-CoV-2 infection among persons who were SARS-CoV-2 negative at enrollment.

Results: Between March and August 2020, 671 households were randomly assigned: 337 (407 participants) to the hydroxychloroquine group and 334 (422 participants) to the control group. Retention at day 14 was 91%, and 10 724 of 11 606 (92%) expected swabs were tested. Among the 689 (89%) participants who were SARS-CoV-2 negative at baseline, there was no difference between the hydroxychloroquine and control groups in SARS-CoV-2 acquisition by day 14 (53 versus 45 events; adjusted hazard ratio, 1.10 [95% CI, 0.73 to 1.66]; P > 0.20). The frequency of participants experiencing adverse events was higher in the hydroxychloroquine group than the control group (66 [16.2%] versus 46 [10.9%], respectively; P = 0.026).

Limitation: The delay between exposure, and then baseline testing and the first dose of hydroxychloroquine or ascorbic acid, was a median of 2 days.

Conclusion: This rigorous randomized controlled trial among persons with recent exposure excluded a clinically meaningful effect of hydroxychloroquine as postexposure prophylaxis to prevent SARS-CoV-2 infection.

Primary funding source: Bill & Melinda Gates Foundation.

Conflict of interest statement

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M20-6519.

Figures

Visual Abstract.. Postexposure Hydroxychloroquine Prophylaxis to Prevent…
Visual Abstract.. Postexposure Hydroxychloroquine Prophylaxis to Prevent SARS-CoV-2 Infection
Clinical trials have ruled out a role of hydroxychloroquine in the treatment of COVID-19, but it has been hypothesized that hydroxychloroquine's activity against SARS-CoV-2 in the laboratory suggests a role in prevention. This randomized controlled trial tests hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection.
Figure 1.. Study flow diagram.
Figure 1.. Study flow diagram.
HCQ = hydroxychloroquine; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
Figure 2.. Cumulative incidence of SARS-CoV-2.
Figure 2.. Cumulative incidence of SARS-CoV-2.
HCQ = hydroxychloroquine; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.

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Source: PubMed

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