Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
CasiTocCOVID
Course of Inflammation and Infection Markers in Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
1 other identifier
observational
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFirst Submitted
Initial submission to the registry
January 22, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedFebruary 1, 2024
January 1, 2024
9 months
January 22, 2024
January 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality rates in the 4 groups
Number of survivors and nonsurvivors
28-day mortality
Secondary Outcomes (5)
Leukocyte count in 4 groups
30-days
C-reactive protein in 4 groups
30-days
Interleukin 6 serum concentrations in 4 groups
30-days
Ferritin serum concentrations in 4 groups
30-days
Procalcitonin serum concentrations in 4 groups
30-days
Study Arms (4)
N, no casirivimab / imdevimab or tocilizumab
No intervention
C, treated with casirivimab / imdevimab
Active comparator
T, Treated with Tocilizumab
Active comparator
C + T, treated with casirivimab / imdevimab and tocilizumab
Active comparator
Interventions
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
Eligibility Criteria
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. 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.
You may qualify if:
- Clinical diagnosis of COVID-19
- CoV-2 delta-variant
- critically ill patients
- ICU
You may not qualify if:
- tuberculosis
- active hepatitis
- HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic of Anesthesiology
Ulm, 89070, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred Weiss, MD
University of Ulm
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 22, 2024
First Posted
January 31, 2024
Study Start
August 1, 2021
Primary Completion
April 28, 2022
Study Completion
December 31, 2023
Last Updated
February 1, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share