- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04467047
Safety and Feasibility of Allogenic MSC in the Treatment of COVID-19 (COVID19)
July 9, 2020 updated by: Hospital de Clinicas de Porto Alegre
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lucia Silla, MD, PhD
- Phone Number: 55 51 33598371
- Email: lsilla@hcpa.edu.br
Study Contact Backup
- Name: Annelise Pezzi, PhD
- Email: annepezzi@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Intravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion
|
Intravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 60 days
|
Assessment of Overall survival at 30 days post intervention
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes on inflammatory C-reactive protein
Time Frame: 60 days
|
To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)
|
60 days
|
Hospital stay
Time Frame: 60 days
|
days of the patients in hospital
|
60 days
|
Oxygenation index (PaO2/FiO2)
Time Frame: 60 days
|
Evaluation of functional respiratory changes: PaO2 / FiO2 ratio
|
60 days
|
Improvement in Liao's score (2020)
Time Frame: 60 days
|
Improvement in Liao's score (2020)
|
60 days
|
Radiological improvement
Time Frame: 60 days
|
Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19
|
60 days
|
Time of COVID19 PCR negativity
Time Frame: 28 days
|
PCR testing to check PCR negativity
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lucia Silla, MD, PhD, Hospital de Clinicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 25, 2020
Primary Completion (Anticipated)
October 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
July 7, 2020
First Submitted That Met QC Criteria
July 9, 2020
First Posted (Actual)
July 10, 2020
Study Record Updates
Last Update Posted (Actual)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 9, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200148 (Amgen Study ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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