Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia
Jane A O’halloran, MD, PhD Emily R Ko, PhD Kevin J Anstrom, MD Eyal Kedar, MD Matthew W Mccarthy, MD Reynold A Panettieri Jr, MD Martin Maillo, Patricia Segura Nunez, MD Anne M Lachiewicz, MS Cynthia Gonzalez, P Brian Smith, Sabina Mendivil-Tuchia De Tai, MD Akram Khan, Alfredo J Mena Lora, MD Matthias Salathe, MD Gerardo Capo, Daniel Rodríguez Gonzalez, MD Thomas F Patterson, MD, ScM Christopher Palma, MD Horacio Ariza, MD; Maria Patelli Lima, MD John Blamoun, MD Esteban C Nannini, MD Eduardo Sprinz, MD Analia Mykietiuk, MSc, MD; Radica Alicic, MD Adriana M Rauseo, MBBS, MPH Cameron R Wolfe, Britta Witting, MD Jennifer P Wang, MD Luis Parra-Rodriguez, MD, MHSc Tatyana Der, BS Kate Willsey, MS Jun Wen, MS Adam Silverstein, Sean M O’brien, PhD Hussein R Al-Khalidi, MD Michael A Maldonado, Richard Melsheimer, PhD William G Ferguson, MS Steven E Mcnulty, MPH Pearl Zakroysky, PhD Susan Halabi, MD, MPH, PhD Daniel K Benjamin Jr, PhD Sandra Butler, DDS Jane C Atkinson, PhD Stacey J Adam, MD, MPH Soju Chang, PhD; Lisa Lavange, PhD Michael Proschan, MD Samuel A Bozzette, PhD William G Powderly, Mahendra Patel, Arun Sanyal, Jason Green, Huimin Wu, Benjamin Linas, Philip Grant, Vivek Iyer, Otto Yang, Bindu Balani, Sam Parnia, Ryan Dare, Caryn G Morse, Estelle S Harris, Glenn Wortmann, Nicholas Hill, Shama Patel, Julia Garcia-Diaz, Suman Thapamager, Megan Devine, Christine M Bojanowski, Barry Meisenberg, Gailen Marshall, Dima Dandachi, Arick Sabin, Anthony Breemo, Suman Sinha, Christopher Goss, Rebecca Reece, Arlette Aouad, Seth Glassman, Peter Morris, Bela Patel, Fatimah Bello, Juliana Cardozo Fernandes, Oscar Carbajal, Lorena Ravera, Mozar Castro, Miguel Villegas-Chiroque, Fernando Oscar Riera, Adrian Camacho, Claudio Stadnik, Jorge Gave, Rodrigo Biondi, Ronal Gamarra Velarde, Jose Cerbino Neto, Juan Ditondo, Marcelo H Losso, Mariano Dolz, Alexandra O’sullivan, Brian Gavin, Maria Beumont-Mauviel, Huyen Ca, Rose Beci, Daniel Molina, Sandhya Rao, Thomas Stock, William Erhardt, Sarah Read, Jessica Springer, Rachel Presti, Ryley Thompson, Kimberly Gray, Cathy Henry, Alem Haile, Michael Klebert, Lisa Kessels, Kathryn Vehe, Kristopher Bakos, Teresa Spitz, Sara Hubert, Raghd Alyatim, Brittany Schneider, Chapelle Ayres, Andrej Spec, Laura Blair, Anita Afghanzada, Natalie Schodl, Lana Wahid, John J Engemann, Gloria Pinero, Beth Mclendon-Arvik, Lynn Whitt, Jenny Shroba, Elizabeth Salsgiver, Candace Alleyne, Anna Gwak, Nicholas Pickell, Jack Spagnoletti, Samson Goh, Katharine Robb, Michael Cenname, Catherine Small, Markus Plate, Rodrigo Burgos, Brenna Lindsey, Fischer Herald, Stephanie Echeverria, Dorendra Lewis, Mahesh Patel, Charles D Bengtson, Andreas Schmid, Kimberly Lovell, Carly Lovelett, Daniel Soule, Daniel Jaremczuk, Jennie Flanagan, Cameron Murray, Kylie Sands, Kyle Flint, Sara Mohaddes, Caryn Harrington, Kylie Broughal, David Sogoian, Karen Cox, Heta Javeri, Philip O Ponce, Danielle O Dixon, Jason E Bowling, Jan E Patterson, Barbara S Taylor, Ruth C Serrano, Kaylin Sallee, Robin Tragus, Gabriel Catano, Irma Scholler, Rose Ann Barajas, Armando Garcia, Bridgette Soileau, Patricia Heard, Manuel Camilo Endo Carvajal, Rukevwe Ehwarieme, Divya Chandramohan, Alejandro Cabo, Abdelhameed Nawwar, Caroline M Quill, Nayeem Choudhury, Ashley Arrington, Isaiah Holyfield, Abby Smith, Glenda Brown, Kyle Varner, Joni Baxter, Tracy Roundy, Mary Co, Mireya Wessolossky, Juan Perez-Velazquez, Jennifer Holter-Chakrabarty, Brittany Karfonta, Juvaria Anjum, Jai Marathe, Myriam Castagne, Daniel Mompoint, Ryan Schroeder, Mallika Rao, Johnathan Nguyen, Jake Plewa, Sue Donlinger, Marylynn Breslin, Susan Dodson, Mitch Jenkins, John Williamson, Elizabeth A Middleton, Mai Tavadze, Romai Sebhatu, Jessica Pierobon, Nate Miller, John Lee, Pratik Doshi, Andrew Dentino, Jessica Martin, Erik Hinojosa, Pablo Torres, Ricardo Sanchez, Gladys Murga, Silvana De La Gala, Jhon Chaiña, Jorge Ramos, Jenny Malca, Kathia Castillo, Johana Calderon Galvez, Maria Lyda Icochea Perez, Claudia Carolina Becerra Nunez, Sandra Betteta Riondato, Sandra Delgado Málaga, Cecilia Barreda Sánchez, Sylvia Sánchez Morales, Myriam Yaringano Palacios, Dora Galarza Cuba, Ivan Hermenegildo, Mayra Falla Benites, Stefania Neyra, Josefina Hernández, Victoria García, Katherine Palacios, Miluska Matos, Fiorella Zuloeta, Fiorella Del Carpio, Gloria Chacaltana
JAMA, doi:10.1001/jama.2023.11043
IMPORTANCE Immune dysregulation contributes to poorer outcomes in COVID-19. OBJECTIVE To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-masked, placebo-controlled clinical trial using a master protocol to investigate immunomodulators added to standard care for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within 14 days and evidence of pulmonary involvement underwent randomization between October 2020 and December 2021. INTERVENTIONS Single infusion of abatacept (10 mg/kg; maximum dose, 1000 mg) or infliximab (5 mg/kg) or a 28-day oral course of cenicriviroc (300-mg loading dose followed by 150 mg twice per day).
MAIN OUTCOMES AND MEASURES The primary outcome was time to recovery by day 28 evaluated using an 8-point ordinal scale (higher scores indicate better health). Recovery was defined as the first day the participant scored at least 6 on the ordinal scale.
RESULTS Of the 1971 participants randomized across the 3 substudies, the mean (SD) age was 54.8 (14.6) years and 1218 (61.8%) were men. The primary end point of time to recovery from COVID-19 pneumonia was not significantly different for abatacept (recovery rate ratio [RRR], 1.12 [95% CI, 0.98-1.28]; P = .09), cenicriviroc (RRR, 1.01 [95% CI, 0.86-1.18]; P = .94), or infliximab (RRR, 1.12 [95% CI, 0.99-1.28]; P = .08) compared with placebo. All-cause 28-day mortality was 11.0% for abatacept vs 15.1% for placebo (odds ratio [OR], 0.62 [95% CI, 0.41-0.94]), 13.8% for cenicriviroc vs 11.9% for placebo (OR, 1.18 [95% CI 0.72-1.94]), and 10.1% for infliximab vs 14.5% for placebo (OR, 0.59 [95% CI, 0.39-0.90]). Safety outcomes were comparable between active treatment and placebo, including secondary infections, in all 3 substudies. CONCLUSIONS AND RELEVANCE Time to recovery from COVID-19 pneumonia among hospitalized participants was not significantly different for abatacept, cenicriviroc, or infliximab vs placebo.
Role of the Funder/Sponsor: Janssen provided infliximab, Bristol Myers Squibb provided abatacept, and AbbVie provided cenicriviroc for use in this trial but did not provide any financial support. Gilead Sciences provided remdesivir for use in this trial but did not provide any financial support. Employees of Janssen and Gilead Sciences participated in discussions about protocol development and in weekly protocol team calls. The final trial protocol was developed by the protocol chair, Dr William Powderly, the IND sponsor Dr Daniel K. Benjamin Jr, and a protocol development committee including representatives from the National Center for Advancing Translational Sciences (NCATS). NCATS had a collaborative role in the trial design, management, interpretation of the data and the preparation of the manuscript along with the protocol chair, the study statisticians and the study writing group.
Group Information: The ACTIV-1 IM Study Group Members are provided in Supplement 3. William Checkley, MD, PhD (Johns Hopkins University, Baltimore, MD); and Beatriz Grinsztejn, MD (Instituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil), for their oversight; the community advisory board, Larisa Caicedo, Ashish Cowlagi, Anna Davis, Lincoln Larmond, Doug Lindsey, Bob Pearson, and the participants and their families for their altruism in participating in this trial; Elizabeth E.S. Cook for editorial support; and Christopher J. Lindsell for contributions to the..
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doi:10.2147/HMER.S230613{ 'indexed': {'date-parts': [[2024, 9, 23]], 'date-time': '2024-09-23T04:31:36Z', 'timestamp': 1727065896082},
'reference-count': 23,
'publisher': 'American Medical Association (AMA)',
'issue': '4',
'content-domain': {'domain': [], 'crossmark-restriction': False},
'published-print': {'date-parts': [[2023, 7, 25]]},
'abstract': '<jats:sec><jats:title>Importance</jats:title><jats:p>Immune dysregulation contributes to '
'poorer outcomes in '
'COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To '
'investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to '
'standard care for COVID-19 pneumonia.</jats:p></jats:sec><jats:sec><jats:title>Design, '
'Setting, and Participants</jats:title><jats:p>Randomized, double-masked, placebo-controlled '
'clinical trial using a master protocol to investigate immunomodulators added to standard care '
'for treatment of participants hospitalized with COVID-19 pneumonia. The results of 3 '
'substudies are reported from 95 hospitals at 85 clinical research sites in the US and Latin '
'America. Hospitalized patients 18 years or older with confirmed SARS-CoV-2 infection within '
'14 days and evidence of pulmonary involvement underwent randomization between October 2020 '
'and December '
'2021.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Single '
'infusion of abatacept (10 mg/kg; maximum dose, 1000 mg) or infliximab (5 mg/kg) or a 28-day '
'oral course of cenicriviroc (300-mg loading dose followed by 150 mg twice per '
'day).</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and '
'Measures</jats:title><jats:p>The primary outcome was time to recovery by day 28 evaluated '
'using an 8-point ordinal scale (higher scores indicate better health). Recovery was defined '
'as the first day the participant scored at least 6 on the ordinal '
'scale.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of the 1971 '
'participants randomized across the 3 substudies, the mean (SD) age was 54.8 (14.6) years and '
'1218 (61.8%) were men. The primary end point of time to recovery from COVID-19 pneumonia was '
'not significantly different for abatacept (recovery rate ratio [RRR], 1.12 [95% CI, '
'0.98-1.28]; <jats:italic>P</jats:italic>\u2009=\u2009.09), cenicriviroc (RRR, 1.01 [95% CI, '
'0.86-1.18]; <jats:italic>P</jats:italic>\u2009=\u2009.94), or infliximab (RRR, 1.12 [95% CI, '
'0.99-1.28]; <jats:italic>P</jats:italic>\u2009=\u2009.08) compared with placebo. All-cause '
'28-day mortality was 11.0% for abatacept vs 15.1% for placebo (odds ratio [OR], 0.62 [95% CI, '
'0.41-0.94]), 13.8% for cenicriviroc vs 11.9% for placebo (OR, 1.18 [95% CI 0.72-1.94]), and '
'10.1% for infliximab vs 14.5% for placebo (OR, 0.59 [95% CI, 0.39-0.90]). Safety outcomes '
'were comparable between active treatment and placebo, including secondary infections, in all '
'3 substudies.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and '
'Relevance</jats:title><jats:p>Time to recovery from COVID-19 pneumonia among hospitalized '
'participants was not significantly different for abatacept, cenicriviroc, or infliximab vs '
'placebo.</jats:p></jats:sec><jats:sec><jats:title>Trial '
'Registration</jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link '
'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" '
'xlink:href="https://classic.clinicaltrials.gov/ct2/show/NCT04593940">NCT04593940</jats:ext-link></jats:p></jats:sec>',
'DOI': '10.1001/jama.2023.11043',
'type': 'journal-article',
'created': {'date-parts': [[2023, 7, 10]], 'date-time': '2023-07-10T15:01:44Z', 'timestamp': 1689001304000},
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'source': 'Crossref',
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'title': 'Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 '
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'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Caryn G.',
'family': 'Morse',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Estelle S.',
'family': 'Harris',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Glenn',
'family': 'Wortmann',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Nicholas',
'family': 'Hill',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Shama',
'family': 'Patel',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Julia',
'family': 'Garcia-Diaz',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Suman',
'family': 'Thapamager',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Megan',
'family': 'Devine',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Christine M.',
'family': 'Bojanowski',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Barry',
'family': 'Meisenberg',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Gailen',
'family': 'Marshall',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Dima',
'family': 'Dandachi',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Arick',
'family': 'Sabin',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Anthony',
'family': 'Breemo',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Suman',
'family': 'Sinha',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Christopher',
'family': 'Goss',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Rebecca',
'family': 'Reece',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Arlette',
'family': 'Aouad',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Seth',
'family': 'Glassman',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Peter',
'family': 'Morris',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Bela',
'family': 'Patel',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Fatimah',
'family': 'Bello',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Juliana',
'family': 'Cardozo Fernandes',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Oscar',
'family': 'Carbajal',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Lorena',
'family': 'Ravera',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Mozar',
'family': 'Castro',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Miguel',
'family': 'Villegas-Chiroque',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Fernando',
'family': 'Oscar Riera',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Adrian',
'family': 'Camacho',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Claudio',
'family': 'Stadnik',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jorge',
'family': 'Gave',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Rodrigo',
'family': 'Biondi',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Ronal',
'family': 'Gamarra Velarde',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jose',
'family': 'Cerbino Neto',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Juan',
'family': 'Ditondo',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Marcelo H.',
'family': 'Losso',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Mariano',
'family': 'Dolz',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Alexandra',
'family': 'O’Sullivan',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Brian',
'family': 'Gavin',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Maria',
'family': 'Beumont-Mauviel',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Huyen',
'family': 'Ca',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Rose',
'family': 'Beci',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Daniel',
'family': 'Molina',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Sandhya',
'family': 'Rao',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Thomas',
'family': 'Stock',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'William',
'family': 'Erhardt',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Sarah',
'family': 'Read',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jessica',
'family': 'Springer',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Rachel',
'family': 'Presti',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Ryley',
'family': 'Thompson',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Kimberly',
'family': 'Gray',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Cathy',
'family': 'Henry',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Alem',
'family': 'Haile',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Michael',
'family': 'Klebert',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Lisa',
'family': 'Kessels',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Kathryn',
'family': 'Vehe',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Kristopher',
'family': 'Bakos',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Teresa',
'family': 'Spitz',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Sara',
'family': 'Hubert',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Raghd',
'family': 'Alyatim',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Brittany',
'family': 'Schneider',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Chapelle',
'family': 'Ayres',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Andrej',
'family': 'Spec',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Laura',
'family': 'Blair',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Anita',
'family': 'Afghanzada',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Natalie',
'family': 'Schodl',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Lana',
'family': 'Wahid',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'John J.',
'family': 'Engemann',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Gloria',
'family': 'Pinero',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Beth',
'family': 'McLendon-Arvik',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Lynn',
'family': 'Whitt',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jenny',
'family': 'Shroba',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Elizabeth',
'family': 'Salsgiver',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Candace',
'family': 'Alleyne',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Anna',
'family': 'Gwak',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Nicholas',
'family': 'Pickell',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jack',
'family': 'Spagnoletti',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Samson',
'family': 'Goh',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Katharine',
'family': 'Robb',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Michael',
'family': 'Cenname',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Catherine',
'family': 'Small',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Markus',
'family': 'Plate',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Rodrigo',
'family': 'Burgos',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Brenna',
'family': 'Lindsey',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Fischer',
'family': 'Herald',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Stephanie',
'family': 'Echeverria',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Dorendra',
'family': 'Lewis',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Mahesh',
'family': 'Patel',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Charles D.',
'family': 'Bengtson',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Andreas',
'family': 'Schmid',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Kimberly',
'family': 'Lovell',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Carly',
'family': 'Lovelett',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Daniel',
'family': 'Soule',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Daniel',
'family': 'Jaremczuk',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jennie',
'family': 'Flanagan',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Cameron',
'family': 'Murray',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Kylie',
'family': 'Sands',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Kyle',
'family': 'Flint',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Sara',
'family': 'Mohaddes',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Caryn',
'family': 'Harrington',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Kylie',
'family': 'Broughal',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'David',
'family': 'Sogoian',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Karen',
'family': 'Cox',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Heta',
'family': 'Javeri',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Philip O.',
'family': 'Ponce',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Danielle O.',
'family': 'Dixon',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jason E.',
'family': 'Bowling',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jan E.',
'family': 'Patterson',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Barbara S.',
'family': 'Taylor',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Ruth C.',
'family': 'Serrano',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Kaylin',
'family': 'Sallee',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Robin',
'family': 'Tragus',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Gabriel',
'family': 'Catano',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Irma',
'family': 'Scholler',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Rose Ann',
'family': 'Barajas',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Armando',
'family': 'Garcia',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Bridgette',
'family': 'Soileau',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Patricia',
'family': 'Heard',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Manuel',
'family': 'Camilo Endo Carvajal',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Rukevwe',
'family': 'Ehwarieme',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Divya',
'family': 'Chandramohan',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Alejandro',
'family': 'Cabo',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Abdelhameed',
'family': 'Nawwar',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Caroline M.',
'family': 'Quill',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Nayeem',
'family': 'Choudhury',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Ashley',
'family': 'Arrington',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Isaiah',
'family': 'Holyfield',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Abby',
'family': 'Smith',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Glenda',
'family': 'Brown',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Kyle',
'family': 'Varner',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Joni',
'family': 'Baxter',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Tracy',
'family': 'Roundy',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Mary',
'family': 'Co',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Mireya',
'family': 'Wessolossky',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Juan',
'family': 'Perez-Velazquez',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jennifer',
'family': 'Holter-Chakrabarty',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Brittany',
'family': 'Karfonta',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Juvaria',
'family': 'Anjum',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jai',
'family': 'Marathe',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Myriam',
'family': 'Castagne',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Daniel',
'family': 'Mompoint',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Ryan',
'family': 'Schroeder',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Mallika',
'family': 'Rao',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Johnathan',
'family': 'Nguyen',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jake',
'family': 'Plewa',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Sue',
'family': 'Donlinger',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Marylynn',
'family': 'Breslin',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Susan',
'family': 'Dodson',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Mitch',
'family': 'Jenkins',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'John',
'family': 'Williamson',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Elizabeth A.',
'family': 'Middleton',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Mai',
'family': 'Tavadze',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Romai',
'family': 'Sebhatu',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
{ 'given': 'Jessica',
'family': 'Pierobon',
'sequence': 'additional',
'affiliation': [{'name': 'for the ACTIV-1 IM Study Group Members'}]},
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