Details

Autor(en) / Beteiligte

• Carvelli, Julien
• Meziani, Ferhat
• Dellamonica, Jean
• Cordier, Pierre-Yves
• Allardet-Servent, Jerome
• Fraisse, Megan
• Velly, Lionel
• Barbar, Saber Davide
• Lehingue, Samuel
• Guervilly, Christophe
• Desgrouas, Maxime
• Camou, Fabrice
• Piperoglou, Christelle
• Vely, Frederic
• Demaria, Olivier
• Karakunnel, Joyson
• Fares, Joanna
• Batista, Luciana
• Rotolo, Federico
• Viotti, Julien
• Boyer-Chammard, Agnes
• Lacombe, Karine
• Le Dault, Erwan
• Carles, Michel
• Schleinitz, Nicolas
• Vivier, Eric

Titel

Avdoralimab (Anti-C5aR1 mAb) Versus Placebo in Patients With Severe COVID-19: Results From a Randomized Controlled Trial (FOR COVID Elimination [FORCE])

Ist Teil von

• Critical care medicine, 2022-12, Vol.50 (12), p.1788-1798

Ort / Verlag

United States

Erscheinungsjahr

2022

Quelle

MEDLINE

Beschreibungen/Notizen

• Severe COVID-19 is associated with exaggerated complement activation. We assessed the efficacy and safety of avdoralimab (an anti-C5aR1 mAb) in severe COVID-19. FOR COVID Elimination (FORCE) was a double-blind, placebo-controlled study. Twelve clinical sites in France (ICU and general hospitals). Patients receiving greater than or equal to 5 L oxygen/min to maintain Sp o2 greater than 93% (World Health Organization scale ≥ 5). Patients received conventional oxygen therapy or high-flow oxygen (HFO)/noninvasive ventilation (NIV) in cohort 1; HFO, NIV, or invasive mechanical ventilation (IMV) in cohort 2; and IMV in cohort 3. Patients were randomly assigned, in a 1:1 ratio, to receive avdoralimab or placebo. The primary outcome was clinical status on the World Health Organization ordinal scale at days 14 and 28 for cohorts 1 and 3, and the number of ventilator-free days at day 28 (VFD28) for cohort 2. We randomized 207 patients: 99 in cohort 1, 49 in cohort 2, and 59 in cohort 3. During hospitalization, 95% of patients received glucocorticoids. Avdoralimab did not improve World Health Organization clinical scale score on days 14 and 28 (between-group difference on day 28 of -0.26 (95% CI, -1.2 to 0.7; p = 0.7) in cohort 1 and -0.28 (95% CI, -1.8 to 1.2; p = 0.6) in cohort 3). Avdoralimab did not improve VFD28 in cohort 2 (between-group difference of -6.3 (95% CI, -13.2 to 0.7; p = 0.96) or secondary outcomes in any cohort. No subgroup of interest was identified. In this randomized trial in hospitalized patients with severe COVID-19 pneumonia, avdoralimab did not significantly improve clinical status at days 14 and 28 (funded by Innate Pharma, ClinicalTrials.gov number, NCT04371367).