Covid19Phase 1NCT04525378
MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome
A Phase 1 study testing Mesenchymal stromal cell-based therapy in people with Covid19 and ARDS, Human, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, ARDS, Human
- What is being tested?
- Mesenchymal stromal cell-based therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2020to 31 Oct 2020
- Phase
- Phase 1
- 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
- Clinical diagnosis of COVID-19 confirmed by RT-PCR;
- Thorax CT image suggestive of viral pneumonia;
- Respiratory failure (SaO2 <93% with O2 at 5L / min)
- Tracheal intubation (first 48 h);
Who cannot join
- Pregnancy or breastfeeding;
- Patients with a history of cancer, chemotherapy in the past 2 years;
- Life expectancy less than 6 months or in exclusive palliative care;
- Severe liver failure, with Child-Pugh score> 12;
- High probability of death in the following 48 h;
- Previous renal failure: patients who were already on dialysis or patients with RFG <30ml / min / 1.73 m2;
- Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital São Rafael
Salvador, Estado de Bahia, 41253-190
Andre Gobatto, MD PHD
About this study
Official title: Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study
Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.
- Conditions
- Covid19, ARDS, Human
- Being tested
- Mesenchymal stromal cell-based therapy
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stromal cell-based therapyOther
Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients will receive standard care. |
| MSC - low dose (2.5x10ˆ7) | Experimental | Patients will receive standard care plus cell therapy. Receives: Other: Mesenchymal stromal cell-based therapy |
| MSC - intermediate dose (5x10ˆ7) | Experimental | Patients will receive standard care plus cell therapy. Receives: Other: Mesenchymal stromal cell-based therapy |
| MSC - high dose (10x10ˆ7) | Experimental | Patients will receive standard care plus cell therapy. Receives: Other: Mesenchymal stromal cell-based therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahospital mortality
Measured: 28 days
Secondary outcomes (6)
Length of stay in the ICU and Hospital
Measured: 28 days
Days without mechanical ventilation in 28 days
Measured: 28 days
PaO2 / FiO2 ratio
Measured: Day 1, Day 2 and Day 7 after cell infusion
Incidence of secondary infections
Measured: 28 days
Incidence of adverse events
Measured: 28 days
Quantification of inflammatory response markers
Exploratory evaluation of changes from baseline (percentage) in serum levels of CRP, LDH, Ferritin levels, a panel of cytokines, chemokines immune cell populations by flow cytometry
Measured: Day 1, Day 3 and Day 7 after cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Jul 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525378
- Sponsor's protocol ID
- PCL02/2020
- Status last verified
- Aug 2020
- First submitted
- 31 Jul 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT04525378
- Acronym / sponsor ID
- PCL02/2020
- Conditions
- Covid19, ARDS, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 25 Aug 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.
Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients will receive standard care. |
| MSC - low dose (2.5x10ˆ7) | Experimental | Other: Mesenchymal stromal cell-based therapyPatients will receive standard care plus cell therapy. |
| MSC - intermediate dose (5x10ˆ7) | Experimental | Other: Mesenchymal stromal cell-based therapyPatients will receive standard care plus cell therapy. |
| MSC - high dose (10x10ˆ7) | Experimental | Other: Mesenchymal stromal cell-based therapyPatients will receive standard care plus cell therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of COVID-19 confirmed by RT-PCR;
- Thorax CT image suggestive of viral pneumonia;
- Respiratory failure (SaO2 <93% with O2 at 5L / min)
- Tracheal intubation (first 48 h);
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding;
- Patients with a history of cancer, chemotherapy in the past 2 years;
- Life expectancy less than 6 months or in exclusive palliative care;
- Severe liver failure, with Child-Pugh score> 12;
- High probability of death in the following 48 h;
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 |
|---|---|---|
| Mesenchymal stromal cell-based therapyIntravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose) | Other | MSC - high dose (10x10ˆ7), MSC - intermediate dose (5x10ˆ7), MSC - low dose (2.5x10ˆ7) |
Primary outcome
Intrahospital mortality
Time frame: 28 days
6 secondary outcomes
Length of stay in the ICU and Hospital
Time frame: 28 days
Days without mechanical ventilation in 28 days
Time frame: 28 days
PaO2 / FiO2 ratio
Time frame: Day 1, Day 2 and Day 7 after cell infusion
Incidence of secondary infections
Time frame: 28 days
Incidence of adverse events
Time frame: 28 days
Quantification of inflammatory response markers
Time frame: Day 1, Day 3 and Day 7 after cell infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal stromal cell-based therapy in people with Covid19 and ARDS, Human, run by D'Or Institute for Research and Education at 1 site in Brazil.
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 7 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 26 Aug 2020. 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 Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Bruno SF Souza, MD PHD (+557132816455, bruno.souza@hsr.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahospital mortality (time frame: 28 days). 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 26 Aug 2020.