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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05433298 |
|
Full text link
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 10, 2023, 4 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : May 10, 2023, 4 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
2022-06-27 |
|
Recruitment status
Last imported at : May 10, 2023, 4 a.m. Source : ClinicalTrials.gov |
Withdrawn |
|
Study design
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
inclusion criteria: both sexes; aged 18 to 79 years old; hospitalized patients; radiological diagnosis of viral pneumonia; virological diagnosis of sars-cov-2 infection; with noninvasive ventilatory support; c-reactive protein and ferritin above the reference value considered normal; assent confirmed to participate in the study. |
|
Exclusion criteria
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
contraindications for use of corticosteroids; immunosuppressive, cytotoxic and antiviral treatment, experimental medications and chronic corticosteroid use; morbid obesity (bmi> 35); multiple organ dysfunction syndrome; pre-malignant neoplastic conditions with life expectancy lower than 1 year old; pre-existing chronic illnesses like chronic dialysis kidney disease, chronic liver disease, congestive heart failure class iv; pulmonary hypertension (who class iii/iv); pre-existing or current thromboembolic pathology; transplanted patients; pre-existing severe allergic reaction; history of hiv and tuberculosis; enrollment in another clinical trial; pregnancy or breastfeeding. |
|
Number of arms
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Paulo Brofman |
|
Inclusion age min
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
79 |
|
Countries
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Brazil |
|
Type of patients
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
|
Severity scale
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
|
Total sample size
Last imported at : May 10, 2023, 4 a.m. Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Safety of intravenously infused UCT-MSC suspension |
|
Notes
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 787, "treatment_name": "Mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |