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

COVID-19 Clinical Trial

— CasiTocCOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06233357
• Other study ID #: University Ulm
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 31, 2023
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• tuberculosis
• active hepatitis
• HIV

Related Conditions & MeSH terms

• COVID-19
• Critical Illness
• Critically Ill
• Outcome, Fatal
• Tocilizumab

Intervention

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

Locations

Country	Name	City	State
Germany	Clinic of Anesthesiology	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rates in the 4 groups	Number of survivors and nonsurvivors	28-day mortality
Secondary	Leukocyte count in 4 groups	Routine blood analysis	30-days
Secondary	C-reactive protein in 4 groups	Routine blood analysis over time	30-days
Secondary	Interleukin 6 serum concentrations in 4 groups	Routine blood analysis over time	30-days
Secondary	Ferritin serum concentrations in 4 groups	Routine blood analysis over time	30-days
Secondary	Procalcitonin serum concentrations in 4 groups	Routine blood analysis over time	30-days