Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19

作者：Thomas G. Stewart, Paulina A. Rebolledo, Ahmad Mourad, Christopher J. Lindsell, David R. Boulware, Matthew W. McCarthy, Florence Thicklin, Idania T. Garcia del Sol, Carolyn T. Bramante, Leslie Lenert, Stephen C. Lim, John Williamson, Orlando Quintero, Jake Scott, Tiffany Schwasinger‐Schmidt, Adit A. Ginde, Mario Castro, Dushyantha Jayaweera, Mark Sulkowski, Nina Gentile, Kathleen M. McTigue, G. Michael Felker, Allison DeLong, Rhonda Wilder, Russell L. Rothman, Sean P. Collins, Sarah E. Dunsmore, Stacey J. Adam, George J. Hanna, Elizabeth Shenkman, Adrian F. Hernandez, Susanna Naggie, Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and Investigators, Ryan Fraser, Mark F. Ward, Jennifer Jackman, M. Patricia McAdams, Julia Vail, Kayla Korzekwinski, Martina Oyelakin, Julie Chopp, Desmon Randle, Samantha Dockery, Rodney H. Adkins, Mathew Crow, Erin Nowell, Kadie Wells, Alicia Herbert, Allegra Stone, Heather Heavlin, Linley Brown, Tina Harding, Amanda Harrington, Meaghan Beauchaine, Kelly Lindblom, Andrea Burns, David Aamodt, Jess Collins, Sheri Dixon, Yue Gao, John Graves, James Grindstaff, Frank E. Harrell, Jessica Lai, Vicky Liao, Itzel Lopez, Elizabeth Manis, Kalley Mankowski, Jessica Marlin, Alyssa Merkel, Sam Nwosu, Savannah Obregon, Dirk Orozco, Nelson Prato, Max Rohde, Jana Shirey-Rice, Krista Vermillion, Jacob Smith, Hsi‐nien Tan, Meghan Vance, Maria Weir, William Vincent, Raina Vincent, Ray Bianchi, Jen Premas, Diana Cordero-Loperena, E. M. Rivera, Madhu Gupta, Greg Karawan, Joseph Arena, Sonaly DeAlmeida, Soroush Ramin, Jaya Nataraj, Julien Dedier, Ana María Ramírez, Katherine Waite, Jason F. Okulicz, Joseph E Marcus, Alexis Southwell, Genice Jacques, Cedar Sexton, David Miller, Ginger Brounce, Constance George-Adebayo, Adeolu Adebayo, J. Zapatero, Julie Clément, Theresa Ronan, Ashley Woods, Christopher Gallegos, Tamara Flys, Olivia Sloan, Anthony Olofintuyi, Joshua Samraj, Jackelyn Samraj, Alma Vasbinder, Amaya Averett, Alex Slandzicki, Aaron P. Milstone, Jessica Wallan, Lindsey Robbs, Claudia Vogel, Sebastian Munoz, David Kavtaradze, Casandra Watson, David Singleton, Marcus Sevier, Maria Rivon, Arnold Del Pilar, Amber Spangler, Sohail Rao, Luis Cantu, Arvind Krishna, Heidi Daugherty, Brandi Kerr, Kathy Evans, Robert Spees, Mailyn Marta, Rowena J Dolor, Lorraine Vergara, Jackie Jordan, Valencia Burruss, Terri Hurst, Igho Ofotokun, Paulina A. Rebolledo, Cecilia Zhang, Veronica E. Smith, Rajesh Prabhu, Krystal Klicka, Amber Lightfeather, Vickie James, Marcella Rogers, Pradeep Parihar, De'Ambra Torress, Chukwuemeka Oragwu, Ngozi Oguego, Rajesh Pillai, Mustafa Juma, Ahab Gabriel, Emad Ghaly, Marian Michal, Michelle Vasquez, Angela Mamon, Michelle Sheets, Gammal Hassanien, Samah Ismail, Yehia Samir, Andrew Meltzer, Soroush Shahamatdar, Ryan Heidish, Scott Brehaut, Angelina Roche, Manisha Mehta, Nicole Koppinger, Jose Baez, Ivone Pagan, Dallal Abdelsayed, Mina Aziz, Philip A. Robinson, Grace Lozinski, Julie Nguyen, Alvin Griffin, Michael J. Morris, Nicole Love, Bonnie Mattox, Raykel Martin, Victoria Pardue, Teddy Rowland, Juan Ruiz-Unger, Lionel Reyes, Yadira Zamora, Navila Bacallao, John J. Cienki, Jonathan B. Cohen, Ying Yuan, Jenny Li, Jeremy Szeto, Mark Sulkowski, Lauren Stelmash, Idania Garcia del Sol, Ledular Morales Castillo, A. Villalba Gutiérrez, Sabrina Prieto, Arch Amon, Andrew R. La Barbera, Andrew Bugajski, Walter Wills, Kellcee Jacklin, Deryl Lamb, Amron Harper, Elmer Stout, Katherine Weeks, Merischia Griffin, Nancy Pyram-Bernard, Arlen Quintero, Eftim Adhami, Giovanni Carrillo, Josette Maria, Diksha Paudel, Oksana Raymond, Jeffrey Summers, Tammy Turner, Ebony Panaccione, Elizabeth Szwast, Ahsan Abdulghani, Pravin Vasoya, Conrad Miller, Hawa Wiley, Austin Chan, Saadia Khizer, Nirav Shah, Oluwadamilola A. Adeyemi, Wei Ning Chi, July Chen, Melissa Morton-Jost, Julie Castex, Phillip Feliciano, Jacqueline Olivo, Maria Maldonado, Anthony G. Vecchiarelli, Diana Gaytan-Alvarez, Vijaya Cherukuri, Santia Lima, Radica Z. Alicic, Allison Lambert, Carissa Urbat, Joni Baxter, Ann Cooper, Dawn Linn, Laura Fisher, Vijay K. Patel, Yuti Patel, Roshan Talati, Priti Patel, Leonard Ellison, Angee Roman, Jeffrey Harrison, James N. Moy, Dina Naquiallah, Binod Shah, Upinder Singh, Yasmin Jazayeri, Andrew O’Donnell, Orlando Quintero, Divya Pathak, Anita Gupta, N Chandrasekar, Clifford Curtis, Briana White, Martha Dockery, Maya M Hicks, Tabitha Fortt, Anisa Fortt, Ingrid Jones-Ince, Alix McKee, Jason Wilson, Brenda Farlow, Nina Gentile, Casey Grady, Randall Richwine, Tearani Williams, Penny Pazier, Edward A. Michelson, Susan Watts, Diluma Kariyawasam, Leann Rodriguez, Jose Luis Monteserin Garcia, Ismarys Manresa, Angel A. Achong, Mari C. Garcia, Sangeeta Khetpal, Faith Posey, Arvind Mahadevan, Martin Gnoni, Carla VandeWeerd, Erica Sappington, Mitchell Roberts, Jennifer Wang, Melissa Adams, Xinyi Ding, Mark D'Andrea, Stephen C. Lim, Wayne Swink, Emily Bozant, Margaret V. Powers‐Fletcher, Delia Miller, Sylvere Mukunzi, Brittney Manning, Carmen Isache, Jennifer Bowman, Angelique Callaghan-Brown, Debra L. Martin, Ashley Ast, Brent Duran, Ashlie Cornejo, Allie Archer, Dushyantha Jayaweera, Maria Almanzar, Vanessa Motel, Neeta Bhat, Daniela Parra-Tanoux, Matthew F Pullen, Paula Campora, Matthew K. Robinson, Michelle Seithel, Akira Sekikawa, Emily Klawson, Jonathan Arnold, Luis Ostrosky‐Zeichner, Virginia Umana, Laura Nielsen, Carolyn Z. Grimes, Thomas F. Patterson, Robin Tragus, Bridgette Soileau, Patrick Jackson, Carolina Hallowell, Heather M. Haughey, Bhavna Vaidya-Tank, Cameron Gould, Parul Goyal, Sue Sommers, Haley Pangburn, Carly Jones, John Williamson, Rica Abbott, Hannah M. Seagle, Mathias DeComarmond, Nicholas Pickell, Unwana Umana, Candace Alleyne, Eddie Armas, Ramon O. Perez Landabur, Michelle De La Cruz, Martha Ballmajo · 发表于：JAMA · 年份：2023 · DOI：10.1001/jama.2023.23363 · 被引用次数：31 · 研究领域：Pharmacological Receptor Mechanisms and Effects、Long-Term Effects of COVID-19、COVID-19 and Mental Health

Importance: The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain. Objective: To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19. Design, Setting, and Participants: The ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for mild to moderate COVID-19. Between August 25, 2022, and January 20, 2023, a total of 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were 30 years or older with confirmed SARS-CoV-2 infection and at least 2 acute COVID-19 symptoms for 7 days or less. Interventions: Participants were randomized to receive fluvoxamine, 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days (n = 601), or placebo (n = 607). Main Outcomes and Measures: The primary outcome was time to sustained recovery (defined as at least 3 consecutive days without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a composite of hospitalization, urgent care visit, emergency department visit, or death; COVID-19 clinical progression scale score; and difference in mean time unwell. Follow-up occurred through day 28. Results: Among 1208 participants who were randomized and received the study drug, the median (IQR) age was 50 (40-60) years, 65.8% were women, 45.5% identified as Hispanic/Latino, and 76.8% reporte...