COVID-19 Acute Respiratory Distress SyndromeCOMODULATENCT06311448
Personalized Targeted Immunomodulation in COVID-19 ARDS
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale: In COVID19 single-targeted immunomodulation, mostly via an IL-6 receptor blocker, was used by a one-size fits all non-targeted approach. In future pandemics the same might occur. However, for individual patients, this might not yield optimal treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Single target immunomodulation
- How many people
- 164 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Mar 2020to 1 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or older, admitted to the ICU due to COVID-induced moderate or severe ARDS as defined by the Berlin criteria, and requiring mechanical ventilation, were eligible for study participation.
Who may be able to join
- At least 18 years of age
- Admitted to ICU due to COVID induced moderate or severe ARDS
- Requiring mechanical ventilation
Who cannot join
- Refusing participation
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus Medical Centre
Rotterdam, South Holland, 3015 GD
About this study
Official title: Personalized Targeted Immunomodulation in Patients With ARDS Related to COVID19 and Future Pandemic Pathogens
Rationale: In COVID19 single-targeted immunomodulation, mostly via an IL-6 receptor blocker, was used by a one-size fits all non-targeted approach. In future pandemics the same might occur. However, for individual patients, this might not yield optimal treatment.
Objectives: This project aims to identify a way to individualize and target immunomodulation, using COVID19 as a testcase for the future.
Read more
- Identify immunological pathways which are associated with outcome in C-ARDS.
- Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDS(Tocilizumab, Anakinra, etc.).
- Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases.
Study type: Retrospective observational multicenter study in the Netherlands.
Study population: Adult patients (≥ 18 years) hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome (ARDS) (i.e., receiving invasive mechanical ventilation) will be included.
Intervention (if applicable): Not applicable (retrospective study design).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. The target population of this study is specific to hospitalized patients with COVID-19.
- Being tested
- Single target immunomodulation, Standard of care
- Keywords
- Immunomodulation, Tociluzimab, Biomarker, Complement inhibitors, IL-6 inhibitors, IL-1 inhibitors, JAK inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single target immunomodulationDrug
Single target immunomodulation compromise of drugs which very specifically target cytokines, chemokines or specific receptors, which are involved in the pathofysiology of COVID-19. For instance, tociluzimab (IL-6 receptor blocker), Anakinra (IL-1 receptor blocker), Eculizimab (Complement inhibitor C5), etc.
Standard of careDrug
Standard of care during COVID-19 pandemic including steroids.
| Study group | Role | What they receive |
|---|---|---|
| Treated with immunomodulation | Adult patients with COVID-19 ARDS admitted to ICU and requiring mechanical ventilation and receiving standard of care treatment (including steroids) and single-target immunomodulation, for example Toculizimab, Anakinra, etc. Receives: Drug: Single target immunomodulation | |
| Not treated with immunomodulation | Adult patients with COVID-19 ARDS admitted to ICU and requiring mechanical ventilation and receiving standard of care treatment (including steroids). Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality up to day 90
Measured: From date of ICU admission up to date of hospital discharge, assessed up to 90 days.
Change in SOFA score
Repeated measurements of SOFA scores during ICU admission will be performed on days 0, 1, 2, 7, 14, 21 and 28. SOFA scores will be compared between days and from the start to the end of ICU admission.
Measured: During the full course of ICU-admission. The length of ICU-stays varies per patient.
Ventilator free days
Number of ventilator free days
Measured: During the full course of ICU admission. The length of ICU-stays varies per patient.
Change in biomarker values
Repeated measurements of biomarkers during ICU admission will be performed on days 0, 1, 2, 7, 14, 21 and 28. Biomarker values will be compared between days and from the start to the end of ICU-admission.
Measured: During the full course of ICU admission. The length of ICU-stays varies per patient.
Costs of immmunomodulation
Costs of immunomodulation will be compared to the costs of dexamethason. Furthermore, we will explore whether patients who were treated with single target immunomodulation have shorter ICU length of stay and more ventilator free days, which also reduce the total costs.
Measured: During the full course of ICU admission. The length of ICU-stays varies per patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start2 Mar 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, Leiden University Medical Center, St. Antonius Hospital
- Responsible party
- Principal investigator, Henrik Endeman, Erasmus Medical Center
- Investigators
- H. Endeman, Dr., Principal investigator, Erasmus Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311448
- Sponsor's protocol ID
- 10094
- Acronym
- COMODULATE
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through a secure data transfer system and appropriate data transfer agreement. (The data set contains personal data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Targeted Immunomodulation in Patients With ARDS Related to COVID19 and Future Pandemic Pathogens
- ClinicalTrials.gov ID
- NCT06311448
- Acronym / sponsor ID
- COMODULATE / 10094
- Keywords
- Immunomodulation, Tociluzimab, Biomarker, Complement inhibitors, IL-6 inhibitors, IL-1 inhibitors, JAK inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Amsterdam UMC, Leiden University Medical Center, St. Antonius Hospital
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 15 Mar 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.
Rationale: In COVID19 single-targeted immunomodulation, mostly via an IL-6 receptor blocker, was used by a one-size fits all non-targeted approach. In future pandemics the same might occur. However, for individual patients, this might not yield optimal treatment.
Objectives: This project aims to identify a way to individualize and target immunomodulation, using COVID19 as a testcase for the future.
- Identify immunological pathways which are associated with outcome in C-ARDS.
- Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDS(Tocilizumab, Anakinra, etc.).
- Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases.
Study type: Retrospective observational multicenter study in the Netherlands.
Study population: Adult patients (≥ 18 years) hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome (ARDS) (i.e., receiving invasive mechanical ventilation) will be included.
Intervention (if applicable): Not applicable (retrospective study design).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. The target population of this study is specific to hospitalized patients with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated with immunomodulation | – | Drug: Single target immunomodulationAdult patients with COVID-19 ARDS admitted to ICU and requiring mechanical ventilation and receiving standard of care treatment (including steroids) and single-target immunomodulation, for example Toculizimab, Anakinra, etc. |
| Not treated with immunomodulation | – | Drug: Standard of careAdult patients with COVID-19 ARDS admitted to ICU and requiring mechanical ventilation and receiving standard of care treatment (including steroids). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older, admitted to the ICU due to COVID-induced moderate or severe ARDS as defined by the Berlin criteria, and requiring mechanical ventilation, were eligible for study participation.
Key inclusion criteria (3 listed)
- At least 18 years of age
- Admitted to ICU due to COVID induced moderate or severe ARDS
- Requiring mechanical ventilation
Key exclusion criteria (1 listed)
- Refusing participation
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 |
|---|---|---|
| Single target immunomodulationSingle target immunomodulation compromise of drugs which very specifically target cytokines, chemokines or specific receptors, which are involved in the pathofysiology of COVID-19. For instance, tociluzimab (IL-6 receptor blocker), Anakinra (IL-1 receptor blocker), Eculizimab (Complement inhibitor C5), etc. | Drug | Treated with immunomodulation |
| Standard of careStandard of care during COVID-19 pandemic including steroids. | Drug | Not treated with immunomodulation |
Primary outcome
Mortality up to day 90
Time frame: From date of ICU admission up to date of hospital discharge, assessed up to 90 days.
Change in SOFA score
Time frame: During the full course of ICU-admission. The length of ICU-stays varies per patient.
Repeated measurements of SOFA scores during ICU admission will be performed on days 0, 1, 2, 7, 14, 21 and 28. SOFA scores will be compared between days and from the start to the end of ICU admission.
Ventilator free days
Time frame: During the full course of ICU admission. The length of ICU-stays varies per patient.
Number of ventilator free days
Change in biomarker values
Time frame: During the full course of ICU admission. The length of ICU-stays varies per patient.
Repeated measurements of biomarkers during ICU admission will be performed on days 0, 1, 2, 7, 14, 21 and 28. Biomarker values will be compared between days and from the start to the end of ICU-admission.
Costs of immmunomodulation
Time frame: During the full course of ICU admission. The length of ICU-stays varies per patient.
Costs of immunomodulation will be compared to the costs of dexamethason. Furthermore, we will explore whether patients who were treated with single target immunomodulation have shorter ICU length of stay and more ventilator free days, which also reduce the total costs.
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 15 Mar 2024.
- Individual participant dataSharing planned: Yes. Data will be made available through a secure data transfer system and appropriate data transfer agreement. (The data set contains personal data.
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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.
H. Endeman, Dr. principal investigator
Erasmus Medical Centre
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 Acute Respiratory Distress Syndrome, run by Erasmus Medical Center at 1 site in Netherlands.
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 3 inclusion and 1 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 15 Mar 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 Netherlands. 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 up to day 90 (time frame: From date of ICU admission up to date of hospital discharge, assessed up to 90 days.). The study lists 5 primary outcomes in all. 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 15 Mar 2024.