| Trial registration number
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NCT04627233 |
Full text link
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT04627233
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First author
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Farzad Ashrafi
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Contact
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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farzad.ashrafi@sbmu.ac.ir
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Registration date
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2020-11-13
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Recruitment status
Last imported at : Nov. 7, 2022, noon
Source : ClinicalTrials.gov
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Unknown
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Study design
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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single-center
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Study aim
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Treatment
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Inclusion criteria
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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inclusion criteria:
- patients hospitalized with a positive sars-cov-2 pcr test and presenting with one or
more clear clinical symptoms of covid-19 disease
- no contraindication to hep-1
- obtained informed consent
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Exclusion criteria
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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- patients who had received any immuno-modulator therapy
- active or chronic kidney/ liver diseases,
- oncological diseases
- other viral infection including hiv and hepatitis.
- any allergic reaction or sensitivity to hep-1
- breast feeding or pregnancy
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Number of arms
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Shahid Beheshti University of Medical Sciences
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Inclusion age min
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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70
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Countries
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Iran;Islamic Republic of
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Type of patients
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Moderate/severe/critical disease at enrollment
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Severity scale
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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5: Moderate/severe/critical disease at enrollment
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Total sample size
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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20
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primary outcome
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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Duration of Hospitalization;Duration of artificial ventilation;Time to clinical improvement of disease symptoms
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Notes
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov
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Phase 1
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Arms
Last imported at : Nov. 14, 2020, 11:31 p.m.
Source : ClinicalTrials.gov
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[{"arm_notes": "", "treatment_id": 595, "treatment_name": "Human ezrin peptide 1 (hep1)", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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