ARDSPhase 2NCT04377334
Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
A Phase 2 study testing MSC in people with ARDS and COVID-19, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- May 2022to Feb 2023
- Phase
- Phase 2
- 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
Who may be able to join
- COVID-19-positive subject
- Horowitz index ≤ 200
- Bilateral opacities on frontal chest radiograph, and
- requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
- no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
- Subject's Age ≥ 18 years
Who cannot join
- COVID-19-negative subject
- Subject's Age < 18 years
- More than 7 days since initiation of mechanical ventilation
- Patient, surrogate or physician not committed to full intensive care support.
- Positive Pregnancy test at the time of screening.
- Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen
Tübingen, 72076
Peter Rosenberger, MD
Peter Rosenberger, MD
About this study
Official title: Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS
To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- Being tested
- MSC
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCBiological
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells
| Study group | Role | What they receive |
|---|---|---|
| MSC Treatment | Experimental | Not described Receives: Biological: MSC |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung injury score
improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points
Measured: day 10
Secondary outcomes (10)
D-dimers
D-dimers blood levels
Measured: day 0, 1, 2, 3, 10 and 15
phenotype
distribution of phenotypes of immune cells
Measured: day 0, 1, 2, 3, 10 and 15
pro-resolving lipid mediators
Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage
Measured: day 0, 1, 2, 3, 10 and 15
cytokines
Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
Measured: day 0, 1, 2, 3, 10 and 15
chemokines
Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
Measured: day 0, 1, 2, 3, 10 and 15
Survival
Survival at 10 days and 28 days
Measured: day 10 and 28
extubation
Time to removal of endotracheal tube
Measured: day 28
lymphocyte subpopulations
lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10)
Measured: day 0, 3, 5 and 10
SARS-CoV-2-specific antibody titers
evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion.
Measured: day 0, 5 and 10
complement molecules (C5-C9)
evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion
Measured: day 0, 5 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study startMay 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rosenberger, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377334
- Sponsor's protocol ID
- RESCOVID
- Status last verified
- Jan 2022
- First submitted
- 16 Apr 2020
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS
- ClinicalTrials.gov ID
- NCT04377334
- Acronym / sponsor ID
- RESCOVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 6 May 2020 (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.
To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC Treatment | Experimental | Biological: MSC |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- COVID-19-positive subject
- Horowitz index ≤ 200
- Bilateral opacities on frontal chest radiograph, and
- requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
- no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
Key exclusion criteria (6 listed)
- COVID-19-negative subject
- Subject's Age < 18 years
- More than 7 days since initiation of mechanical ventilation
- Patient, surrogate or physician not committed to full intensive care support.
- Positive Pregnancy test at the time of screening.
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 |
|---|---|---|
| MSCinfusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells | Biological | MSC Treatment |
Primary outcome
lung injury score
Time frame: day 10
improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points
10 secondary outcomes
D-dimers
Time frame: day 0, 1, 2, 3, 10 and 15
phenotype
Time frame: day 0, 1, 2, 3, 10 and 15
pro-resolving lipid mediators
Time frame: day 0, 1, 2, 3, 10 and 15
cytokines
Time frame: day 0, 1, 2, 3, 10 and 15
chemokines
Time frame: day 0, 1, 2, 3, 10 and 15
Survival
Time frame: day 10 and 28
extubation
Time frame: day 28
lymphocyte subpopulations
Time frame: day 0, 3, 5 and 10
SARS-CoV-2-specific antibody titers
Time frame: day 0, 5 and 10
complement molecules (C5-C9)
Time frame: day 0, 5 and 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Peter Rosenberger, Prof. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MSC in people with ARDS and COVID-19, run by University Hospital Tuebingen 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Jan 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Rosenberger, Prof. (+49707129 ext. 86622, peter.rosenberger@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung injury score (time frame: day 10). 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 27 Jan 2022.