Fundació Lluita Contra Les Infeccions, Badalona, Spain
Sofía Sábato, Susana Benet, Beatriz Mothe, Roger Paredes, José Moltó, Roger Paredes, Beatriz Mothe, José Moltó, Susana Benet & Sofia Sabato
Department of Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Spain
Sofía Sábato, Susana Benet, Beatriz Mothe, Roger Paredes, José Moltó, Roger Paredes, Beatriz Mothe, José Moltó, Susana Benet & Sofia Sabato
Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Stanford University, Stanford, CA, USA
Angela J. Rogers & Angela J. Rogers
Division of Biostatistics and Health Data Science, University of Minnesota, Minneapolis, MN, USA
Thomas A. Murray, Melissa Skeans, Cavan Reilly, James D. Neaton, Adam A. C. Burns, Amy Carlsen, Anita Carter, Eileen Denning, Alain DuChene, Kate Eckroth, Nicole Engen, Alex Frase, Greg Grandits, Merrie Harrison, Payton Kaiser, Sue Meger, Shweta Sharma Mistry, Thomas Murray, Kien Quan, Siu Fun Quan, Cavan Reilly, Melissa Skeans, Greg Thompson, Jamie Walski & Deborah Wentworth
IrsiCaixa, Badalona, Spain
Beatriz Mothe, Roger Paredes, Roger Paredes & Beatriz Mothe
CIBERINFEC, Instituto de Salud Carlos III, Madrid, Spain
Beatriz Mothe, José Moltó, Beatriz Mothe & José Moltó
Department of Infectious Diseases and Immunity, University of Vic – Central University of Catalonia (UVic-UCC), Barcelona, Spain
Beatriz Mothe & Beatriz Mothe
Division of Infectious Diseases, Department of Medicine, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA
Ahmad Mourad & Ahmad Mourad
Strengthening Institutional Capacity for Research Administration (SICRA), Lira, Uganda
Francis Kiweewa, Mary Grace Nalubega, Nicholus Sebudde, Francis Kiweewa, Francis Kiweewa, Nicholus Sebudde, Mary Grace Nalubega, Doreen Ebong, Harrient Tino & Francis Kiweewa
Lira Regional Referral Hospital, Lira, Uganda
Francis Kiweewa, Nicholus Sebudde, Francis Kiweewa, Francis Kiweewa, Nicholus Sebudde & Francis Kiweewa
UT Southwestern Medical Center, Dallas, TX, USA
Dena Kamel, Mamta K. Jain & Mamta Jain
MRC/UVRI & LSHTM Uganda Research Unit, Entebbe, Uganda
Joseph Lutaakome, Jonathan Kitonsa, Joseph Lutaakome, Jonathan Kitonsa, Moses Kibirige, Gloria Lubega, Margaret Nalaaki, Deus Wangi, Roger Kisuule & Joseph Lutaakome
Department of Medicine, Houston Methodist Hospital, Houston, TX, USA
Eleftherios Mylonakis & Eleftherios Mylonakis
Department of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland
Dominique L. Braun & Dominique L. Braun
The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA
Timothy Hatlen, Timothy Hatlen, Betty Anderson, Mario Guerrero, Dannae Martin, Ramiro Correa, Avon Vargas, Gabe Hartnell & Cynthia Temblador
Makerere University Lung Institute, Makerere University, Kampala, Uganda
Ivan Kimuli, Ivan Kimuli & Ivan Kimuli
Joint Clinical Research Centre, Lubowa, Uganda
Cissy Kitko, Henry Mugerwa, Cissy Kityo, Henry Mugerwa & Henry Mugerwa
Tampa General Hospital, University of South Florida, Tampa, FL, USA
Kami Kim & Kami Kim
Department of Medicine, Department of Veterans Affairs Medical Center, University of California, San Francisco, San Francisco, CA, USA
Phyllis C. Tien, Phyllis Tien & Heather Freasier
NIAID, NIH, FNL (Frederick National Laboratory), Frederick, ML, USA
Jeroen Highbarger & Jeroen Highbarger
Laboratory of Human Retrovirology and Immunoinformatics, Frederick National Laboratory for Cancer Research, Frederick, MD, USA
Ashley L. McCormack & Ashley McCormack
Infectious Diseases Section, VA Medical Center, Washington, DC, USA
Adriana Sanchez, Adriana Sanchez & Adriana Sánchez
Department of Infectious Diseases, CHIP Center of Excellence for Health, Immunity, and Infections, Rigshospitalet, Copenhagen, Denmark
Daniel D. Murray, Jens D. Lundgren, Jens D. Lundgren, Dorthe Raben, Daniel D. Murray, Tomas O. Jensen, Bitten Aagaard, Charlotte B. Nielsen, Katharina Krapp & Katja Lisa Kanne
MRC Clinical Trials Unit at UCL, University College London, London, UK
Abdel G. Babiker, Sarah L. Pett, Anna L. Goodman, Abdel G. Babiker, Sarah L. Pett, Fleur Hudson, Mahesh K. B. Parmar, Anna L. Goodman, Jonathan Badrock, Dipa Noor, Adam Gregory, Katharine Goodall, Nicola Harris & James Wyncoll
Office of Research and Development, US Department of Veterans Affairs, Washington, DC, USA
Victoria J. Davey & Victoria J. Davey
Division of Pulmonary, Critical Care, Allergy and Immunology, Department of Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA
D. Clark Files & D. Clark Files
Department of Population Health Science and Policy, Icahn School of Medicine, New York, NY, USA
Annetine C. Gelijns & Annetine Gelijns
Division of Clinical Research, NIAID, NIH, Bethesda, USA
Elizabeth S. Higgs & Elizabeth S. Higgs
VA Medical Center, George Washington University, Washington, DC, USA
Virginia L. Kan, Virginia Kan & Virginia Kan
Kirby Institute, University of New South Wales, Sydney, Australia
Gail V. Matthews, Mark Polizzotto, Sally Hough, Katherine Ognenovska, Catherine Carey, Christina C. Chang, Nila J. Dharan, Gail Matthews, Anthony Kelleher, Sophie Virachit, Sarah Davidson, Daniel J. Bice, Ruth Flynn & Gesalit Cabrera
National Institute of Allergy and Infectious Diseases, US National Institutes of Health, Bethesda, USA
H. Clifford Lane, H. Clifford Lane, Elizabeth S. Higgs, Susan E. Vogel, John Tierney, Mary C. Smolskis, Laura A. McNay, Sharon Segal Raim, Katy Shaw-Saliba, Mark Miller, David Vallee, Lucy Chung & Nayon Kang
Department of Infection at Guy’s and St Thomas’ NHS Foundation Trust, King’s College London, London, UK
Anna L. Goodman & Anna L. Goodman
Frederick National Laboratory for Cancer Research/Leidos Biomedical Research, Inc., Frederick, MD, USA
Robin L. Dewar, Ven Natarajan, Weizhong Chang, Brad T. Sherman, Adam W. Rupert, Helene Highbarger, Michael Baseler, Perrine Lallemand, M. Tauseef Rehman, Tom Imamichi, Sylvain Laverdure, Sharada Paudel, Kyndal Cook, Kendra Haupt, Lisheng Dai, M. Ayub Khan, Allison Hazen & Yunden Badralmaa
Foundation for the National Institutes of Health, Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) and Operation Warp Speed, North Bethesda, MD, USA
Stacey J. Adam
INSIGHT Community Advisory Board, New York, USA
Claire Rappoport
Cardiothoracic Surgical Trials Network (CTSN) ICC, Icahn School of Medicine at Mount Sinai, New York, NY, USA
Ellen Moquete, Karen O’Sullivan, Evan Accardi, Sarah Burris, Alan Moskowitz & Mary Beth Marks
Nashville ICC, Vanderbilt University Medical Center, Nashville, TN, USA
Wesley H. Self, Adit A. Ginde, Matthew W. Semler, Todd W. Rice, Crystal North, Samuel Brown, Angela Rogers, Cathryn Oldmixon & Margaret Hays
Veterans Affairs ICC, US Department of Veterans Affairs, Washington, DC, USA
Kousick Biswas, Tammy Bremer, Tara Burke, Brittany Koker, Anne Davis-Karim, David Pittman & Shikha S. Vasudeva
Washington ICC, Veterans Affairs Medical Center, Washington, DC, USA
Amy Weintrob, Laura Poplieski, Kimberley Viens & Melissa Turner
Duke University Hospital, Durham, NC, USA
Peter Smith, Thomas Holland & Mary Motta
The Miriam Hospital, Providence, Rhode Island, USA
Quynh-Lam Tran, Ralph D. Rogers, Fadi Shehadeh & Evangelia K. Mylona
Rhode Island Hospital, Providence, Rhode Island, USA
Ralph D. Rogers, Fadi Shehadeh, Evangelia K. Mylona & Matthew Kaczynski
CHRISTUS Spohn Shoreline Hospital, Corpus Christi, TX, USA
Srikanth Ramachandruni, Brenda Hernandez, Melissa Shadle & Polly Mock
Stanford University Hospital & Clinics, Stanford, USA
Rosemary Vojnik & Jennifer G. Wilson
Wake Forest Baptist Health, Winston-Salem, NC, USA
Kevin W. Gibbs, Lori Flores & D. Rafael Palacios
Cedars Sinai Medical Center, Los Angeles, CA, USA
Peter Chen, Susan Jackson, Antonina Caudill, Brittany Mattison & Lea Dahlke
Minneapolis VA Medical Center, Minneapolis, MN, USA
Ken Kunisaki
Public Health Institute at Denver Health, Denver, CO, USA
Edward Gardner
Salem VAMC, Salem, VA, USA
Shikha Vasudeva, Stephanie Nagy-Agren, Tracy Ochalek, Ayesha Khan & Carolyn Gould
Washington DC VA Medical Center, Washington, DC, USA
Amy Weintrob, Laura Popielski, Kimberley Viens & Melissa Turner
MRC/UVRI and LSHTM Uganda Research Unit, Entebe, Uganda
Gloria Lubega, Moses Kibirige, Margaret Nalaaki, Deus Wangi & Phiona Nabagala
Gulu Regional Centre of Excellence, Referral Hospital, Gulu, Uganda
Robert Kidega, Daizy Faith Oryem, Emmanuel Ocung, Geoffery Amone, Florence Apio, Deborah Nyiraguhirwa, Priscilla Irene Alum & Carol Nantongo
Strengthening Institutional Capacity for Research Administration at Makerere University Lung Institute, Kampala, Uganda
Bruce Kirenga, Queen Mbabazi, Ivan Segawa & Angella Atukunda
Masaka Regional Referral Hospital, Masaka, Uganda
Naboth Tukamwesiga, Hadijah Naluyinda, Julian Nandhego & Phiona Nabaggala
St. Francis Hospital, Nsambya, Uganda
Evelyn Nabankema, Ivan Okoth, Oscar Mugerwa & Nabuuma Theresa
Spain Site Coordinator Center, Hospital Universitari Germans Trias I Pujol, Badalona, Spain
Maria Expósito, José Badillo, Ana Martínez & Elena Abad
Barcelona Institute for Global Health (ISGlobal), Hospital Clínic – Universitat de Barcelona, Barcelona, Spain
Antoni Trilla, Leire Balerdi, Almudena Legarda, Montserrat Roldan & José Muñoz
Hospital General Universitario Gregorio Marañón, Madrid, Spain
Eduardo Fernández-Cruz, Marisa Di Natale, Sergiu Padure, Jimena Gomez & Christina Ausín
Hospital Universitary Vall d’Hebron, Barcelona, Spain
Magda Campins, Eva del Amo, Xavier Martínez, Susana Otero & Blanca Borras
University Hospital Arnau de Vilanova, Lleida, Spain
Jose Luis Morales-Rull, Anna Maria Moreno Pena, Laia Martínez & Raquel Martí
University Hospital Zurich and Institute of Medical Virology, University of Zurich, Zurich, Switzerland
Huldrych F. Günthard, Emily West, Manuela Grüttner-Durmaz, Carmen Tallón de Lara & Antonio Amodeo
Institute of Human Virology-Nigeria (IHVN), Abuja, Nigeria
Nnakelu Eriobu, Vivian Kwaghe, Zaiyad Habib, Godwin Idoko & Blessing Uche
Tan Tock Seng Hospital, Singapore, Singapore
Barnaby E. Young, Po Ying Chia, Sean W. X. Ong, Shaiu Hui Diong & He Ping Yeo
S.S. drafted the manuscript as writing group lead. S.B., clinical trial execution, drafted the manuscript as writing group lead. A.J.R, clinical trial execution and writing group lead. T.A.M. and M.S., statistical analysis and prepare figures. B.M., R.P., A.M., F.K., D.K., M.K.J., J.L., M.G.N., N.S., E.M., D.L.B., T.H., I.K., C.K., H.M., J.K., K.K., P.C.T, clinical trial execution and revised the manuscript. J.H., A.L.M, laboratory analysis. A.S., D.D.M., protocol writing team, clinical trial execution and revised the manuscript. A.G.B., previous London INSIGHT ICC (International Coordinating Center) Lead, V.J.D., VA INSIGHT ICC Lead, D.C.F., PETAL lead, A.C.G, CTSN ICC lead, E.S.H, NIH DCR ICC lead, V.L.K., Washington INSIGHT ICC lead, G.V.M., SYD ICC lead, S.L.P, current London ICC lead, H.C.L, NIAID lead, C.R., SDMC lead, A.G., revised the manuscript, J.D.L., VATICO PI, INSIGHT Copenhagen ICC lead, protocol team and writing group. J.M., writing group lead, clinical trial execution. S.S. and S.B. contributed equally to this work and shared first authorship. J.D.L. and J.M. contributed equally to this work and share last authorship. All authors read and approved the final manuscript.