COVID-19CasiTocCOVIDNCT06233357
Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
An observational study of COVID-19 and Outcome, Fatal, run by University of Ulm at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19, Outcome, Fatal, Tocilizumab
- What is being tested?
- treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
- Type of treatment
- Injection or infusion
- How many people
- 95 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of COVID-19
- CoV-2 delta-variant
- critically ill patients
- ICU
Who cannot join
- tuberculosis
- active hepatitis
- HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Outcome, Fatal, Tocilizumab, Interleukin 6, Critically Ill
- Being tested
- treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)
- Keywords
- COVID-19, critically ill, ICU, casirivimab imdevimab, tocilizumab, interleukin 6, C-reactive protein, ferritin, procalcitonin, mortality
- Medical subject headings
- COVID-19, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)Drug
Also called casirivimab / imdevimab, tocilizumab
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
| Study group | Role | What they receive |
|---|---|---|
| N, no casirivimab / imdevimab or tocilizumab | No intervention | |
| C, treated with casirivimab / imdevimab | Active comparator Receives: Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T) | |
| T, Treated with Tocilizumab | Active comparator Receives: 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 | Active comparator Receives: Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rates in the 4 groups
Number of survivors and nonsurvivors
Measured: 28-day mortality
Secondary outcomes (5)
Leukocyte count in 4 groups
Routine blood analysis
Measured: 30-days
C-reactive protein in 4 groups
Routine blood analysis over time
Measured: 30-days
Interleukin 6 serum concentrations in 4 groups
Routine blood analysis over time
Measured: 30-days
Ferritin serum concentrations in 4 groups
Routine blood analysis over time
Measured: 30-days
Procalcitonin serum concentrations in 4 groups
Routine blood analysis over time
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Aug 2021
- Primary completion28 Apr 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manfred Weiss, University of Ulm
- Investigators
- Manfred Weiss, MD, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233357
- Sponsor's protocol ID
- University Ulm
- Acronym
- CasiTocCOVID
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Course of Inflammation and Infection Markers in Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
- ClinicalTrials.gov ID
- NCT06233357
- Acronym / sponsor ID
- CasiTocCOVID / University Ulm
- Conditions
- COVID-19, Outcome, Fatal, Tocilizumab, Interleukin 6, Critically Ill
- Keywords
- COVID-19, critically ill, ICU, casirivimab imdevimab, tocilizumab, interleukin 6, C-reactive protein, ferritin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| N, no casirivimab / imdevimab or tocilizumab | – | –No intervention |
| C, treated with casirivimab / imdevimab | – | Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)Active comparator |
| T, Treated with Tocilizumab | – | Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)Active comparator |
| C + T, treated with casirivimab / imdevimab and tocilizumab | – | Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)Active comparator |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Clinical diagnosis of COVID-19
- CoV-2 delta-variant
- critically ill patients
- ICU
Key exclusion criteria (3 listed)
- tuberculosis
- active hepatitis
- HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)Also: casirivimab / imdevimab, tocilizumabIgG 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 | Drug | C + T, treated with casirivimab / imdevimab and tocilizumab, C, treated with casirivimab / imdevimab, T, Treated with Tocilizumab |
Primary outcome
Mortality rates in the 4 groups
Time frame: 28-day mortality
Number of survivors and nonsurvivors
5 secondary outcomes
Leukocyte count in 4 groups
Time frame: 30-days
C-reactive protein in 4 groups
Time frame: 30-days
Interleukin 6 serum concentrations in 4 groups
Time frame: 30-days
Ferritin serum concentrations in 4 groups
Time frame: 30-days
Procalcitonin serum concentrations in 4 groups
Time frame: 30-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Weiss, MD principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Outcome, Fatal, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rates in the 4 groups (time frame: 28-day mortality). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.