| Trial registration number
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CTRI/2021/06/034327 |
Full text link
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56875
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First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Dr Ayesha Mariam
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Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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ayesha.mariam@yahoo.com
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Registration date
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-06-21
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Recruitment status
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Confirmed diagnosis of COVID 19 infection(COVID RT-PCR positive or HRCT suggestive of CORADS 4/5/6) <br/ >Mild disease presenting within the first 7 days of illness
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Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Children with moderate or severe COVID 19 infection at presentation. <br/ >Children with comorbidities on immunosuppressants or on steroids. <br/ >Parents or guardian not consenting to be part of the study.
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Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Apollo Hospitals
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Inclusion age min
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3
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Inclusion age max
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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16
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Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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India
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Type of patients
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mild disease at enrollment
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Severity scale
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1: Mild disease at enrollment
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Total sample size
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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150
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primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Effect on disease progression in children affected with COVID 19Timepoint: 14 days
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Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (2.0)
differs from found arms (3.0)
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Phase
Last imported at : Sept. 8, 2021, 1:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 242, "treatment_name": "Budesonide", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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