COVID-19Phase 1COVID19NCT04467047
Safety and Feasibility of Allogenic MSC in the Treatment of COVID-19
A Phase 1 study testing Mesenchymal Stromal Cells infusion in people with COVID-19 and Sars-CoV2, run by Hospital de Clinicas de Porto Alegre.
Trial summary
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Mesenchymal Stromal Cells infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2020to 30 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR)
- The patient or legal donor agrees to participate in the study and signs the informed consent.
- Patients with orange or red criteria according to the score proposed by Liao et al (2020)
Who cannot join
- Patient with pregnancy, are planning to become pregnant or breastfeeding
- Patients with malignant blood-borne diseases such as HIV or syphilis
- Not consenting for clinical trial
- Patients with other than orange or red criteria according to the score proposed by Liao et al (2020)
Trial locations and contacts
No sites are listed yet.
Annelise Pezzi, PhD contact
About this study
Official title: Safety and Feasibility of Allogenic Mesenchymal Stromal Cells in the Treatment of COVID-19
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm. Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
Read the detailed description
Coronavirus-19 Disease (COVID-19), caused by the Sars-Cov-2 virus, which occurs as a growing pandemic in early 2020 and currently represents an emergency state worldwide. Several reports have shown that the first step in the pathogenesis of Sars-Cov-2 is the recognition of the angiotensin I converting enzyme (ACE2) receptor by the virus. This ACE2 receptor is widely distributed on the surface of human cells, especially as type II alveolar cells and capillary endothelium, however bone marrow, lymph nodes, thymus and spleen are known as immune cells, such as T and lymphocytes. B and macrophages, are negatives to ACE2. These results suggest that immunotherapy can be used to treat infected patients. However, an immunomodulatory capacity cannot be so strong, if just one or two major immunological factors used, as the virus can cause a "cytokine storm", such as IL-2, IL-6, IL-7, GSCF, IP10 , MCP1, MIP1A and TNFα, followed by edema, gas exchange dysfunction, acute respiratory distress syndrome, cardiac injury and secondary infection that can lead to death. Therefore, avoiding a "cytokine storm" may be the key to treating patients infected with Sars-Cov-2. Mesenchymal stem cells (MSCs), due to their potential for immunomodulatory activity, can have beneficial effects in preventing or attenuating the cytokine storm. Because MSCs have been widely used in cell therapy, from basic research to clinical trials. Safety and efficacy have been clearly documented in several clinical trials, especially in immune-mediated inflammatory diseases, such as graft versus host disease (GVHD). The objective of the study is to verify the safety and feasibility of using allogeneic bone marrow mesenchymal stem cells in patients with SARS-CoV-2.
- Being tested
- Mesenchymal Stromal Cells infusion
- Keywords
- Mesenchymal Stromal Cells, COVID-19, Sars-CoV2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal Cells infusionBiological
Intravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion Receives: Biological: Mesenchymal Stromal Cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Assessment of Overall survival at 30 days post intervention
Measured: 60 days
Secondary outcomes (6)
Changes on inflammatory C-reactive protein
To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)
Measured: 60 days
Hospital stay
days of the patients in hospital
Measured: 60 days
Oxygenation index (PaO2/FiO2)
Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
Measured: 60 days
Improvement in Liao's score (2020)
Improvement in Liao's score (2020)
Measured: 60 days
Radiological improvement
Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19
Measured: 60 days
Time of COVID19 PCR negativity
PCR testing to check PCR negativity
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start25 Jul 2020 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
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.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucia Silla, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467047
- Sponsor's protocol ID
- 20200148
- Acronym
- COVID19
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 10 Jul 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 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Allogenic Mesenchymal Stromal Cells in the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04467047
- Acronym / sponsor ID
- COVID19 / 20200148
- Keywords
- Mesenchymal Stromal Cells, COVID-19, Sars-CoV2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 25 Jul 2020 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 10 Jul 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.
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe cases, it was found that aberrant pathogenic T cells and inflammatory monocytes are rapidly activated and then producing a large number of cytokines and inducing an inflammatory storm. Mesenchymal stem cells (MSCs) have been shown to possess a comprehensive powerful immunomodulatory function. This study aims to investigate the safety and efficacy of intravenous infusion of mesenchymal stem cells in severe patients with COVID-19.
Detailed description
Coronavirus-19 Disease (COVID-19), caused by the Sars-Cov-2 virus, which occurs as a growing pandemic in early 2020 and currently represents an emergency state worldwide. Several reports have shown that the first step in the pathogenesis of Sars-Cov-2 is the recognition of the angiotensin I converting enzyme (ACE2) receptor by the virus. This ACE2 receptor is widely distributed on the surface of human cells, especially as type II alveolar cells and capillary endothelium, however bone marrow, lymph nodes, thymus and spleen are known as immune cells, such as T and lymphocytes. B and macrophages, are negatives to ACE2. These results suggest that immunotherapy can be used to treat infected patients. However, an immunomodulatory capacity cannot be so strong, if just one or two major immunological factors used, as the virus can cause a "cytokine storm", such as IL-2, IL-6, IL-7, GSCF, IP10 , MCP1, MIP1A and TNFα, followed by edema, gas exchange dysfunction, acute respiratory distress syndrome, cardiac injury and secondary infection that can lead to death. Therefore, avoiding a "cytokine storm" may be the key to treating patients infected with Sars-Cov-2. Mesenchymal stem cells (MSCs), due to their potential for immunomodulatory activity, can have beneficial effects in preventing or attenuating the cytokine storm. Because MSCs have been widely used in cell therapy, from basic research to clinical trials. Safety and efficacy have been clearly documented in several clinical trials, especially in immune-mediated inflammatory diseases, such as graft versus host disease (GVHD). The objective of the study is to verify the safety and feasibility of using allogeneic bone marrow mesenchymal stem cells in patients with SARS-CoV-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: Mesenchymal Stromal Cells infusionIntravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR)
- The patient or legal donor agrees to participate in the study and signs the informed consent.
- Patients with orange or red criteria according to the score proposed by Liao et al (2020)
Key exclusion criteria (4 listed)
- Patient with pregnancy, are planning to become pregnant or breastfeeding
- Patients with malignant blood-borne diseases such as HIV or syphilis
- Not consenting for clinical trial
- Patients with other than orange or red criteria according to the score proposed by Liao et al (2020)
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 Cells infusionIntravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion | Biological | Intervention |
Primary outcome
Overall survival
Time frame: 60 days
Assessment of Overall survival at 30 days post intervention
6 secondary outcomes
Changes on inflammatory C-reactive protein
Time frame: 60 days
Hospital stay
Time frame: 60 days
Oxygenation index (PaO2/FiO2)
Time frame: 60 days
Improvement in Liao's score (2020)
Time frame: 60 days
Radiological improvement
Time frame: 60 days
Time of COVID19 PCR negativity
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
Annelise Pezzi, PhD contact
Lucia Silla, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stromal Cells infusion in people with COVID-19 and Sars-CoV2, run by Hospital de Clinicas de Porto Alegre.
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 4 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 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Lucia Silla, MD, PhD (55 51 33598371, lsilla@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 60 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 10 Jul 2020.