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

January 31, 2024 updated by: Manfred Weiss, University of Ulm

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89070
        • Clinic of Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • tuberculosis
  • active hepatitis
  • HIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
N, no casirivimab / imdevimab or tocilizumab
No intervention
C, treated with casirivimab / imdevimab
Active comparator
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
Other Names:
  • casirivimab / imdevimab
  • tocilizumab
T, Treated with Tocilizumab
Active comparator
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
Other Names:
  • casirivimab / imdevimab
  • tocilizumab
C + T, treated with casirivimab / imdevimab and tocilizumab
Active comparator
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
Other Names:
  • casirivimab / imdevimab
  • tocilizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rates in the 4 groups
Time Frame: 28-day mortality
Number of survivors and nonsurvivors
28-day mortality

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leukocyte count in 4 groups
Time Frame: 30-days
Routine blood analysis
30-days
C-reactive protein in 4 groups
Time Frame: 30-days
Routine blood analysis over time
30-days
Interleukin 6 serum concentrations in 4 groups
Time Frame: 30-days
Routine blood analysis over time
30-days
Ferritin serum concentrations in 4 groups
Time Frame: 30-days
Routine blood analysis over time
30-days
Procalcitonin serum concentrations in 4 groups
Time Frame: 30-days
Routine blood analysis over time
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Manfred Weiss, MD, University of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

April 28, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University Ulm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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