Details

Autor(en) / Beteiligte

• O'Halloran, Jane A
• Ko, Emily R
• Anstrom, Kevin J
• Kedar, Eyal
• McCarthy, Matthew W
• Panettieri, Jr, 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
• Mykietiuk, Analia
• Alicic, Radica
• Rauseo, Adriana M
• Wolfe, Cameron R
• Witting, Britta
• Wang, Jennifer P
• Parra-Rodriguez, Luis
• Der, Tatyana
• Willsey, Kate
• Wen, Jun
• Silverstein, Adam
• O'Brien, Sean M
• Al-Khalidi, Hussein R
• Maldonado, Michael A
• Melsheimer, Richard
• Ferguson, William G
• McNulty, Steven E
• Zakroysky, Pearl
• Halabi, Susan
• Benjamin, Jr, Daniel K
• Butler, Sandra
• Atkinson, Jane C
• Adam, Stacey J
• Chang, Soju
• LaVange, Lisa
• Proschan, Michael
• Bozzette, Samuel A
• Powderly, William G

Titel

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

Ist Teil von

• JAMA : the journal of the American Medical Association, 2023-07, Vol.330 (4), p.328

Ort / Verlag

United States

Erscheinungsjahr

2023

Link zum Volltext

Beschreibungen/Notizen

• Immune dysregulation contributes to poorer outcomes in COVID-19. To investigate whether abatacept, cenicriviroc, or infliximab provides benefit when added to standard care for COVID-19 pneumonia. 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. 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). 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. 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. Time to recovery from COVID-19 pneumonia among hospitalized participants was not significantly different for abatacept, cenicriviroc, or infliximab vs placebo. ClinicalTrials.gov Identifier: NCT04593940.