tetano
Editor, Senior Moderator
Int J Infect Dis
. 2022 Aug 17;S1201-9712(22)00475-1.
doi: 10.1016/j.ijid.2022.08.007. Online ahead of print.
Pembrolizumab in combination with tocilizumab in high-risk hospitalized COVID-19 patients (COPERNICO): A randomized proof-of-concept phase II study
Matilde Sánchez-Conde[SUP] 1 [/SUP], Pilar Vizcarra[SUP] 1 [/SUP], José Manuel Pérez-García[SUP] 2 [/SUP], María Gion[SUP] 3 [/SUP], María Pilar Martialay[SUP] 4 [/SUP], Javier Taboada[SUP] 5 [/SUP], Alberto Alonso-Fernández[SUP] 6 [/SUP], Miguel Sampayo-Cordero[SUP] 7 [/SUP], Andrea Malfettone[SUP] 7 [/SUP], Isabel Tena[SUP] 7 [/SUP], Sergio De La Torre[SUP] 8 [/SUP], Antonio Llombart-Cussac[SUP] 9 [/SUP], Javier Cortés[SUP] 10 [/SUP]
Affiliations
Abstract
Objectives: Severe 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 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.
Methods: Randomized, controlled, open-label, phase 2 trial in patients with severe SARS-CoV-2-infection to assess the hospitalization period to discharge.
Results: Twelve patients were randomized (P+TCZ+SOC, n=7; SOC, n=5). Nine (75%) were males, with a median age of 68 (41-79) years. The median time to discharge for 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.
Conclusions: The addition of P and TCZ to SOC reduced the hospitalization period, with higher and faster discharges without sequelae than SOC alone.
Keywords: COVID-19; Pembrolizumab; SARS-CoV-2-infection; tocilizumab.
. 2022 Aug 17;S1201-9712(22)00475-1.
doi: 10.1016/j.ijid.2022.08.007. Online ahead of print.
Pembrolizumab in combination with tocilizumab in high-risk hospitalized COVID-19 patients (COPERNICO): A randomized proof-of-concept phase II study
Matilde Sánchez-Conde[SUP] 1 [/SUP], Pilar Vizcarra[SUP] 1 [/SUP], José Manuel Pérez-García[SUP] 2 [/SUP], María Gion[SUP] 3 [/SUP], María Pilar Martialay[SUP] 4 [/SUP], Javier Taboada[SUP] 5 [/SUP], Alberto Alonso-Fernández[SUP] 6 [/SUP], Miguel Sampayo-Cordero[SUP] 7 [/SUP], Andrea Malfettone[SUP] 7 [/SUP], Isabel Tena[SUP] 7 [/SUP], Sergio De La Torre[SUP] 8 [/SUP], Antonio Llombart-Cussac[SUP] 9 [/SUP], Javier Cortés[SUP] 10 [/SUP]
Affiliations
- PMID: 35987472
- DOI: 10.1016/j.ijid.2022.08.007
Abstract
Objectives: Severe 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 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.
Methods: Randomized, controlled, open-label, phase 2 trial in patients with severe SARS-CoV-2-infection to assess the hospitalization period to discharge.
Results: Twelve patients were randomized (P+TCZ+SOC, n=7; SOC, n=5). Nine (75%) were males, with a median age of 68 (41-79) years. The median time to discharge for 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.
Conclusions: The addition of P and TCZ to SOC reduced the hospitalization period, with higher and faster discharges without sequelae than SOC alone.
Keywords: COVID-19; Pembrolizumab; SARS-CoV-2-infection; tocilizumab.