NCT06233357

Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application

Course of Inflammation and Infection Markers in Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 95 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated (ethics application nr. 129/22 of the ethics commssion of the university Ulm.

Detailed description

According to the recommendations, IgG seronegative SARSCoV2-Spike antibody (\< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP \> 75 mg/l or IL-6 \> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight. 28-day mortality and 30-day time course of leukocyte counts and serum concentrations of C-reactive protein (CRP), procalcitonin (PCT), interleukin 6 (IL-6) and ferritin in 4 patient groups, i. e., treated without (N) or with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T), were evaluated.

Conditions

• COVID-19
• Outcome, Fatal
• Tocilizumab
• Interleukin 6
• Critically Ill

Interventions

Type	Name	Description
DRUG	treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)	IgG seronegative SARSCoV2-Spike antibody (\< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP \> 75 mg/l or IL-6 \> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-04-28
• Completion: 2023-12-31
• First posted: 2024-01-31
• Last updated: 2024-02-01

Locations

1 site across 1 country: Germany