Abstract
Introduction: High pro-inflammatory cytokine IL-6 levels correlate with lymphocyte exhaustion and cases of severe Covid-19. We hypothesized that the anti-IL6 receptor antibody T combined with the immune-activating anti–PD-1 antibody P might interrupt the hyperinflammation and restore the cellular immunocompetence.
Objective: The efficacy and safety of T+P was assessed in high-risk, hospitalized pts with Covid-19 pneumonia who were not yet on mechanical ventilation.
Methods: COPERNICO was a randomized, controlled, open-label, phase 2 trial involving pts with SARS-CoV-2 infection, lymphocyte ≤0,8x106/mL, SpO2≤ 92%, and ≥1 of the following signs: increased ferritin, IL-6, D-dimer, C-reactive protein, lactate dehydrogenase, or erythrocyte sedimentation rate; or no clinical improvement within 48 hours after T-based regimen. Pts were randomly assigned (2:1 ratio) to receive T (8 mg/kg) + P (200 mg) or standard of care (SOC). The primary endpoint was the hospitalization period from randomization to hospital discharge. We assume a 10% α and 20% β errors (24 pts). An interim analysis was planned with 12 pts enrolled.
Results: With 12 pts randomized (7 pts to T+P, 5 pts to SOC), median age was 66.4 years,75% were male. Median time to hospital discharge was 10 days (D) in the T+P group and 47.5 D in the SOC group (HR, 4.9; P=0.03), meeting the primary endpoint at interim analysis. Death occurred in 1 (14.3%) patient of the T+P group on day 57 due to myositis and 2 (40%) pts of the SOC group during the first 24 D due to Covid-19 pneumonia (HR, 0.24; P=0.2).
Conclusions: In high-risk, hospitalized pts with Covid-19 pneumonia, T+P reduced the hospitalization period, supporting further clinical investigation.
Footnotes
Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, OA1266.
This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2021