Course of Inflammation and Infection Markers in Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
Overview
- Phase
- Not Applicable
- Intervention
- treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
- Conditions
- COVID-19
- Sponsor
- University of Ulm
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Mortality rates in the 4 groups
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Manfred Weiss
Principal Investigator
University of Ulm
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of COVID-19
- •CoV-2 delta-variant
- •critically ill patients
Exclusion Criteria
- •tuberculosis
- •active hepatitis
Arms & Interventions
C, treated with casirivimab / imdevimab
Active comparator
Intervention: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
T, Treated with Tocilizumab
Active comparator
Intervention: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
C + T, treated with casirivimab / imdevimab and tocilizumab
Active comparator
Intervention: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
Outcomes
Primary Outcomes
Mortality rates in the 4 groups
Time Frame: 28-day mortality
Number of survivors and nonsurvivors
Secondary Outcomes
- C-reactive protein in 4 groups(30-days)
- Ferritin serum concentrations in 4 groups(30-days)
- Leukocyte count in 4 groups(30-days)
- Interleukin 6 serum concentrations in 4 groups(30-days)
- Procalcitonin serum concentrations in 4 groups(30-days)