Trial registration number
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IRCT20200723048178N3 |
Full text link
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/57938
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First author
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Ahmed Farhan
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Contact
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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drfarhan992@gmail.com
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Registration date
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2021-08-13
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Recruitment status
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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single-center
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Study aim
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Provide written informed consent
Subjects age > 18 years at the time of signing the Informed Consent Form.
Male or Female
Must have a clinical diagnosis of COVID-19, with at least one clinical symptom (e.g., fever ≥38°C, fatigue, cough) and a positive result by the reverse-transcription polymerase chain reaction (RT-PCR) testing or equivalent.
Individuals with severe COVID-19 symptoms according to Berlin Criteria
Hospitalized patients and on Mechanical Ventilation
Patients requiring FiO2 of 0.5 or more and a PEEP of 5 mmHg or more
Ability to provide informed consent or an authorized representative can sign the informed consent
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Exclusion criteria
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Pregnant females
Patients with HIV infection.
Patients with active tuberculosis or a history of treatment for pulmonary tuberculosis
Patients with a CrCl of less than 30 ml/minute
Patients with heart disease and an ejection fraction of 30% or less
Patients with advanced liver disease
Patients allergic to methylprednisolone
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Number of arms
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Pakistan Institute of Medical Sciences, Islamabad
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Inclusion age min
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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60
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Countries
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Not reported
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Type of patients
Last imported at : Sept. 13, 2021, 12:30 p.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 : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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6: Severe disease at enrollment
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Total sample size
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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60
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primary outcome
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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In-hospital mortality
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Notes
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Not reported
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Arms
Last imported at : Sept. 13, 2021, 12:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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