| Trial registration number
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CTRI/2020/12/029954 |
Full text link
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50385
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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 Nimisha Nimkar
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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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urmil4004@yahoo.co.in
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Registration date
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-12-21
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Recruitment status
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Jan. 15, 2021, 12:45 a.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 : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Center
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Jan. 15, 2021, 12:45 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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Pts tested positive for Covid19 and enrolled within 24hrs. <br/ >Pts willing to give consent to participate in study.
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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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Pts with k/h/o hypersensitivity to a surfactant. <br/ >Lactating or pregnant mother. <br/ >Pts requiring ICU care as per guidelines and invasive ventilation.
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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 : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Dr Nimisha Nimkar Investigator Investigated study
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Inclusion age min
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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90
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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 : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Moderate/severe disease at enrollment
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Severity scale
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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4: Moderate/severe disease at enrollment
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Total sample size
Last imported at : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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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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Rapid antigen status of Oropharyngeal and Nasopharyngeal swabs on Day 3 in each group.Timepoint: Rapid antigen status of Oropharyngeal and Nasopharyngeal swabs on Day 3 in each group.
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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 : Jan. 15, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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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": 1954, "treatment_name": "Surfactant saline", "treatment_type": "Nasal spray", "pharmacological_treatment": "Non 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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