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

U

University of Ulm

Status

Completed

Conditions

COVID-19
Interleukin 6
Tocilizumab
Critically Ill
Outcome, Fatal

Treatments

Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)

Study type

Observational

Funder types

Other

Identifiers

NCT06233357
University Ulm

Details and patient eligibility

About

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.

Full 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.

Enrollment

95 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • tuberculosis
  • active hepatitis
  • HIV

Trial design

95 participants in 4 patient groups

N, no casirivimab / imdevimab or tocilizumab
Description:
No intervention
C, treated with casirivimab / imdevimab
Description:
Active comparator
Treatment:
Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
T, Treated with Tocilizumab
Description:
Active comparator
Treatment:
Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
C + T, treated with casirivimab / imdevimab and tocilizumab
Description:
Active comparator
Treatment:
Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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