Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
- Sponsor
- University of Ulm
- Study ID
- NCT06233357
- Status
- Completed
Conditions
- COVID-19
- Critically Ill
- Interleukin 6
- Outcome, Fatal
- Tocilizumab
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T) — DRUGIgG 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
Study Details
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.
Key Dates
- Start date
- Aug 1, 2021
- Status verified
- Jan 2024
- Primary completion
- Apr 28, 2022
- Completion
- Dec 31, 2023
Study Design
- Enrollment
- 95 participants (actual)
Arms
- Arm: N, no casirivimab / imdevimab or tocilizumabNo intervention
- Arm: C, treated with casirivimab / imdevimabActive comparator
- Arm: T, Treated with TocilizumabActive comparator
- Arm: C + T, treated with casirivimab / imdevimab and tocilizumabActive comparator
Primary Outcome Measure
Mortality rates in the 4 groups [ Time Frame: 28-day mortality ]
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