Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial
MD, MS * [Professor] Samuel M Brown, MD Christina E Barkauskas, PhD [Professor] Birgit Grund, MS Shweta Sharma, PhD [Professor] Andrew N Phillips, Lindsay Leither, MD, MSc Ithan D Peltan, MD Michael Lanspa, MD Daniel L Gilstrap, MD Ahmad Mourad, Kathleen Lane, MD MPH Jeremy R Beitler, MD, MPH Alexis L Serra, RRT Ivan Garcia, MD [Professor] Eyad Almasri, MD Mohamed Fayed, MD Kinsley Hubel, Middleton, Barrios, Mathews, Goel Estelle S Harris, MD Elizabeth A Middleton, Macy A G Barrios, MD, MPH Kusum S Mathews, MD, MS Neha N Goel, MD Samuel Acquah, MD Jarrod Mosier, MD MPH Cameron Hypes, Elizabeth Salvagio Campbell, MD Akram Khan, MD [Professor] Catherine L Hough, MD Jennifer G Wilson, MD Joseph E Levitt, Levitt Abhijit Duggal, Siddharth Dugar, MD, MSCR [Professor] Andrew J Goodwin, MD, MSCR Charles Terry, MD [Professor] Peter Chen, MD Sam Torbati, MD Nithya Iyer, MD Uriel S Sandkovsky, MD Nicholas J Johnson, Matthay Bryce R H Robinson, MD [Professor] Michael A Matthay, Neil R Aggarwal, Ivor S Douglas, MD, MSc Jonathan D Casey, MD Manuel Hache-Marliere, J Georges Youssef, MD, MPH William Nkemdirim, MD [Professor] Brad Leshnower, MD Omar Awan, MD Sonal Pannu, MD Darragh Shane O'mahony, MD [Professor] Prasad Manian, MD MPH [Professor] J W Awori Hayanga, Glenn W Wortmann, Bruno M Tomazini, Robert F Miller, Jens-Ulrik Jensen, Daniel D Murray, Nina A Bickell, Jigna Zatakia, Sarah Burris, Elizabeth S Higgs, Ven Natarajan, Robin L Dewar, Adam Schechner, Nayon Kang, Alejandro Arenas-Pinto, Fleur Hudson, Adit A Ginde, Wesley H Self, Angela J Rogers, Cathryn F Oldmixon, Haley Morin, Adriana Sanchez, Amy C Weintrob, Alexandre Biasi Cavalcanti, Anne Davis-Karim, Nicole Engen, Eileen Denning, B Taylor Thompson, Annetine C Gelijns, Virginia Kan, Babiker, Higgs. Victoria J Davey, Lane, Neaton, Gelijns, Thompson, Kan, Davey, Babiker, Polizzotto, Brown, Ginde, Barkauskas. Investigation: Brown, Barkauskas, Grund, Sharma, Phillips, Leither, Peltan, Lanspa, Gilstrap, Mourad, Lane, Beitler, Serra, Garcia, Almasri, Fayed, Hubel Jens D Lundgren, Abdel G Babiker, James D Neaton, H Clifford Lane, John Tierney, Susan E Vogel, Laura A Mcnay, Kelly Cahill, Page Crew, Ratna Sardana, Sharo Segal Raim, Katy Shaw-Saliba, Negin Atri, Mark Miller, David Vallee, Lucy Chung, Yvette Delph, Stacey J Adam, Sarah Read, Ruxandra Draghia-Akli, Rachel Harrigan, Amy Carlsen, Anita Carter, Alain Duchene, Kate Eckroth, Alex Frase, Merrie Harrison, Sue Meger, Kien Quan, Siu Fun Quan, Cavan Reilly, Greg Thompson, Jamie Walski, Alan J Moskowitz, Emilia Bagiella, Ellen Moquete, Karen O'sullivan, Mary E Marks, Evan Accardi, Emily Kinzel, Gabriela Bedoya, Lopa Gupta, Jessica R Overbey, Maria L Padillia, Milerva Santos, Marc A Gillinov, Marissa A Miller, Wendy C Taddei-Peters, Kathleen Fenton, Peter K Smith, Andrew M Vekstein, Emily R Ko, Mashael S Al-Hegelan, Lauren M Mcgowan, Mary Motta, Shauna Howell, Francine Bent, Rachel Kalager, Emmanuel Chan, Heather L Aloor, S Michelle Griffin, Anna Covington, Beth Mclendon-Arvik, Barbara Bussadori, Mary Miller-Bell, Cathy Sampey, Vincent Gaver, Beth A Hollister, Dana M Giangiacomo, Alena Pauley, Aashay Patel, Chris Classon, Madison Frazier, Robyn Osborne, Debbi H Conlon, Marybeth Joshi, Robert L Gottlieb, Michael Mack, Mezgebe Berhe, Clinton Haley, Emma Dishner, Christopher Bettacchi, Kevin Golden, Erin Duhaime, Madison Ryan, Catherine Tallmadge, Lorie Estrada, Felecia Jones, Samantha Villa, Samantha Wang, Raven Robert, Tanquinisha Coleman, Laura Clariday, Rebecca Baker, Mariana Hurutado-Rodriguez, Nazia Iram, Michelle Fresnedo, Allyson Davis, Kiara Leonard, Noelia Ramierez, Jon Thammavong, Krizia Duque, Emma Turner, Tammy Fisher, Matthay Dianna Robinson, Desirae Ransom, Nicholas Maldonado, Erica Lusk, Aaron Killian, Adriana Palacios, Edilia Solis, Janet Jerrow, Matthew Watts, Heather Whitacre, Elizabeth Cothran, William Bender, Jeffrey Miller, Katherine Nugent, Woodrow Farrington, Kim T Baio, Mary K Mcbride, Michele Fielding, Sonya Mathewson, Kristina Porte, Elizabeth Haley, Susan Rogers, Derrick Tyler, Emerson Perin, Briana Costello, Alexander Postalian, Rizwan Sohail, Punit Hinsu, Carolyn Watson, Casey Kappenman, James Chen, Kim Walker, Melyssa Fink, Gabrielle Phillip, Kim Mahon, Lydia Sturgis, Patrick Maher, Linda Rogers, Nicole Ng, Jason Marshall, Adel Bassily-Marcus, Ivy Cohen, Shamini Ramoo, Aryan Malhotra, Jonathan Kessler, Rebekah Goetz, Vinay Badhwar, Jeremiah Hayanga, Lisa Giblin Sutton, Roger Williams, Elizabeth Berry Bartolo, Dmitry Walker, Robin Bunner, Chad Glaze, Tanja Aucremanne, James Bishop, Macey Kelley, Autumn Peterson, Erica Sauerborn, Robin Reckart, Brittany Miller, Aaron Mittel, Anita Darmanian
The Lancet Respiratory Medicine, doi:10.1016/s2213-2600(23)00147-9
Background: Aviptadil (vasoactive intestinal peptide) is a lung-protective neuropeptide and remdesivir is a nucleotide prodrug of an adenosine analog, both of which may improve outcomes for COVID-19 patients with acute hypoxemic respiratory failure. Methods: Daily 12-hour infusions of aviptadil or placebo for three successive days and daily infusions of remdesivir or placebo for up to 10 successive days were studied using a master protocol for adults hospitalized for COVID-19 with acute hypoxemic respiratory failure. Participants could be randomized to both study treatments in a 2×2 factorial design or to just one of the agents. For both treatment comparisons, the primary outcome, assessed at Day 90, was a 6-category ordinal outcome ranging from return to home with liberation from supplemental oxygen (recovery) for ≥77 days to death. Mortality through Day 90 was a key secondary outcome. The independent data and safety monitoring board recommended stopping the aviptadil trial on
Supplementary Material Refer to Web version on PubMed Central for supplementary material. Lancet Respir Med. Author manuscript; available in PMC 2024 September 01.
Author Manuscript
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DOI record:
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