| Trial registration number
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IRCT20190101042197N2 |
Full text link
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/55380
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First author
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Dr. Abbas Mohammadi Matin
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Contact
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Info@tarmimava.com
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Registration date
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-04-19
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Recruitment status
Last imported at : June 21, 2021, 1:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
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Allocation
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
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Masking
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
multi-center
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Study aim
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
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Inclusion criteria
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Acute respiratory distress Syndrome of moderate to severe type (PaO2/ FiO2 <200mmHg)
Age range between 18 to 65 years
Men and Women
No participation in another clinical trial during this study
Chest X-ray showed bilateral infiltration with pulmonary edema
Definitive infection with COVID-19 confirmed by PCR
Patients who have given themselves and their families a full explanation of the study process and have obtained informed written consent
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Exclusion criteria
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Cancer or malignant diseases
Pregnant women or planning to become pregnant
Symptoms or history of liver or kidney failure
History of lung surgery or Lung transplantation
Having an autoimmune disease
Infectious viral infection
Proven blood clotting disorders
Participate in other clinical trials simultaneously
Severe trauma occurred within 14 days before screening
They are undergoing hemodialysis or peritoneal dialysis
Bone marrow transplantation
Have a history of epilepsy, need continuous anticonvulsant therapy
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Number of arms
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Tarmim Ava Baran Knowledge Based Company
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Inclusion age min
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
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Inclusion age max
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
65
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Countries
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Severe disease at enrollment
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Severity scale
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
6: Severe disease at enrollment
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Total sample size
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
72
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primary outcome
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Adverse reaction and severe adverse reaction
Murray lung injury score
PaO2/FiO2
The number of days the survivor was out of ICU
Blood biochemistry (CRP)
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Notes
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 1/Phase 2
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Arms
Last imported at : April 20, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 788, "treatment_name": "Mesenchymal stem cells exosomes", "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"}]
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