v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | IRCT20200417047113N1 |
|
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) |
S.shojaei@megenetherapy.com |
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Registration date
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
2020-04-24 |
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Recruitment status
Last imported at : Dec. 20, 2020, 1 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) |
Blind label |
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Center
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
single-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) |
All COVID-19 patients confirmed by CT scan with possitive RT-PCR |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Pregnancy or breastfeeding Known HIV, HBV or HCV infection Patients with malignant tumor, other serious systemic diseases and psychosis Diabetic patients Patients who are participating in other clinical trials |
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Number of arms
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
7 |
|
Funding
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Middle East Gene Therapy corporation |
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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) |
Moderate disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
3: 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) |
70 |
|
primary outcome
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
Fever Number of breathes per minute Pulmonary volume Pulmonary capacity Airway resistance Lung elasticity Chest pressure Cough Skin disorders |
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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 1/Phase 2 |
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Arms
Last imported at : Oct. 26, 2020, 8:37 a.m. Source : Iranian Registry of Clinical Trials (IRCT) |
[{"arm_notes": "0.1 * 107 NK cells per kilogram of patient weight.", "treatment_id": 867, "treatment_name": "Natural killer cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "0.5 * 107 NK cells per kilogram of patient weight", "treatment_id": 867, "treatment_name": "Natural killer cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "1 * 107 NK cells per kilogram of patient weight", "treatment_id": 867, "treatment_name": "Natural killer cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "1.5 * 107 NK cells per kilogram of patient weight", "treatment_id": 867, "treatment_name": "Natural killer cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "2 * 107 NK cells per kilogram of patient weight", "treatment_id": 867, "treatment_name": "Natural killer 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"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |