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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06233357
Acronym
CasiTocCOVID
Enrollment
95
Registered
2024-01-31
Start date
2021-08-01
Completion date
2023-12-31
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

COVID-19, critically ill, ICU, casirivimab imdevimab, tocilizumab, interleukin 6, C-reactive protein, ferritin, procalcitonin, mortality

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.

Interventions

DRUGtreated 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

Sponsors

University of Ulm
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of COVID-19 * CoV-2 delta-variant * critically ill patients * ICU

Exclusion criteria

* tuberculosis * active hepatitis * HIV

Design outcomes

Primary

MeasureTime frameDescription
Mortality rates in the 4 groups28-day mortalityNumber of survivors and nonsurvivors

Secondary

MeasureTime frameDescription
Interleukin 6 serum concentrations in 4 groups30-daysRoutine blood analysis over time
Ferritin serum concentrations in 4 groups30-daysRoutine blood analysis over time
Leukocyte count in 4 groups30-daysRoutine blood analysis
C-reactive protein in 4 groups30-daysRoutine blood analysis over time
Procalcitonin serum concentrations in 4 groups30-daysRoutine blood analysis over time

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026