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Completed

NCT Number: NCT06233357

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Critical Illness Critically Ill Disease Attributes Infections Interleukin 6 Lung Diseases Nidovirales Infections Outcome, Fatal Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Tocilizumab Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic of Anesthesiology

Ulm, 89070, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • tuberculosis
  • active hepatitis
  • HIV

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Mortality rates in the 4 groups

    Time frame: 28-day mortality

    Number of survivors and nonsurvivors

Secondary outcomes

  1. Leukocyte count in 4 groups

    Time frame: 30-days

    Routine blood analysis

  2. C-reactive protein in 4 groups

    Time frame: 30-days

    Routine blood analysis over time

  3. Interleukin 6 serum concentrations in 4 groups

    Time frame: 30-days

    Routine blood analysis over time

  4. Ferritin serum concentrations in 4 groups

    Time frame: 30-days

    Routine blood analysis over time

  5. Procalcitonin serum concentrations in 4 groups

    Time frame: 30-days

    Routine blood analysis over time

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study title

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

Acronym: CasiTocCOVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 31, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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