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| Column | Value |
|---|---|
| Trial registration number | IRCT20200217046526N2 |
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Full text link
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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First author
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Contact
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
shahverdi@royaninstitute.org |
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Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2020-04-13 |
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Recruitment status
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Completed |
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Study design
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Open label |
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Center
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Treatment |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Confirmation of 2019-nCoV infection by RT-PCR Diagnosis of ARDS according to the Berlin definition of ARDS Requiring supplemental oxygen, OR Pneumonia that is judged by chest radiograph or CT PaO2/oxygen absorption concentration (FiO2) ≤ 300MMHG Pulmonary imaging shows that the focused progress > 50% in 24-48 hours Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU <48 hours SOFA score between 2-3 point |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Severe allergies or allergies after 1st injection to stem cell preparations and their components Patients with a malignant tumor, other serious systemic diseases, and psychosis Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus Patients with previous history of pulmonary embolism Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections) Liver or kidney SOFA score of more than 3 points; combined with other organ failure (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30) Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia Continuous use of immunosuppressive agents or organ transplants in the past 6 months In vitro life support (ECMO, ECCO2R, RRT) Pregnant or lactating women Uncontrolled underling disease |
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Number of arms
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
3 |
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Funding
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Iranian academic center for education culture and research |
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
65 |
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Countries
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Iran |
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Type of patients
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Mild/moderate disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
60 |
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primary outcome
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Adverse events assesment Blood oxygen saturation |
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Notes
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
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Phase
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Phase 2/Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
[{"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": 1773, "treatment_name": "Mesenchymal stem cell-derived extracellular vesicles (msc-evs)", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |