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O’Halloran, Jane A.; Ko, Emily R.; Anstrom, Kevin J.; Kedar, Eyal; McCarthy, Matthew W.; Panettieri, Reynold A.; Maillo, Martin; Nunez, Patricia Segura; Lachiewicz, Anne M.; Gonzalez, Cynthia; Smith, P. Brian; de Tai, Sabina Mendivil-Tuchia; Khan, Akram; Lora, Alfredo J. Mena; Salathe, Matthias; Capo, Gerardo; Gonzalez, Daniel Rodríguez; Patterson, Thomas F.; Palma, Christopher; Ariza, Horacio; Lima, Maria Patelli; Blamoun, John; Nannini, Esteban C.; Sprinz, Eduardo; [...]

Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia : A Randomized Clinical Trial : A Randomized Clinical Trial

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  • Medientyp: E-Artikel
  • Titel: Abatacept, Cenicriviroc, or Infliximab for Treatment of Adults Hospitalized With COVID-19 Pneumonia : A Randomized Clinical Trial : A Randomized Clinical Trial
  • Beteiligte: O’Halloran, Jane A.; Ko, Emily R.; Anstrom, Kevin J.; Kedar, Eyal; McCarthy, Matthew W.; Panettieri, Reynold A.; Maillo, Martin; Nunez, Patricia Segura; Lachiewicz, Anne M.; Gonzalez, Cynthia; Smith, P. Brian; de Tai, Sabina Mendivil-Tuchia; Khan, Akram; Lora, Alfredo J. Mena; Salathe, Matthias; Capo, Gerardo; Gonzalez, Daniel Rodríguez; Patterson, Thomas F.; Palma, Christopher; Ariza, Horacio; Lima, Maria Patelli; Blamoun, John; Nannini, Esteban C.; Sprinz, Eduardo; [...]
  • Erschienen: American Medical Association (AMA), 2023
  • Erschienen in: JAMA
  • Sprache: Englisch
  • DOI: 10.1001/jama.2023.11043
  • ISSN: 0098-7484
  • Schlagwörter: General Medicine
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <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> = .09), cenicriviroc (RRR, 1.01 [95% CI, 0.86-1.18]; <jats:italic>P</jats:italic> = .94), or infliximab (RRR, 1.12 [95% CI, 0.99-1.28]; <jats:italic>P</jats:italic> = .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>