Pembrolizumab in combination with tocilizumab in high-risk hospitalized COVID-19 patients (COPERNICO): A randomized proof-of-concept phase II study

Abstract IntroductionSevere coronavirus disease 2019 (COVID-19) is associated with immune dysregulation and hyperinflammation (lymphocyte exhaustion and elevated IL-6). Pembrolizumab (P; immune-activating anti-PD-1 antibody) plus tocilizumab (TCZ; anti-IL6 receptor antibody) might interrupt the hyperinflammation and restore the cellular immunocompetence. We assessed the efficacy and safety of P + TCZ + standard of care [SOC] in high-risk, hospitalized, COVID-19 pneumonia patients without mechanical ventilation.MethodsRandomized, controlled, open-label, phase 2 trial in patients with severe SARS-CoV-2-infection to assess the hospitalization period to discharge.ResultsTwelve patients were randomized (P + TCZ + SOC, n = 7; SOC, n = 5). Nine (75%) were males, with a median age of 68 (41–79) years. Median time to discharge with P + TCZ + SOC and SOC was 10 and 47.5 days (p = 0.03), with 0 (n = 1 patient had P–related grade 5 myositis) and 2 COVID-19-related deaths, respectively.ConclusionsThe addition of P and TCZ to SOC reduced the hospitalization period, with higher and faster discharges without sequelae than SOC alone.