| Trial registration number
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CTRI/2020/09/028088 |
Full text link
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47829
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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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Vivek Chauhan
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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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drvivekshimla@yahoo.com
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Registration date
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-09-28
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Recruitment status
Last imported at : Nov. 6, 2020, 11:45 p.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 : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Nov. 6, 2020, 11:45 p.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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Diagnosis of SARS-CoV-2 admitted in our tertiary care hospital in Shimla with an oxygen saturation of <90% on room air
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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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o Patients unwilling to provide consent for the drug regimen. <br/ >o Patients who die within 48 hours of admission in our hospital. <br/ >o Patients having GFR < 30 or Severe Asthma or Severe COPD <br/ >
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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 : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Vivek Chauhan
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Inclusion age min
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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99
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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 : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Severe/critical disease at enrollment
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Severity scale
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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7: Severe/critical disease at enrollment
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Total sample size
Last imported at : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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34
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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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Primary Outcome: Change in the marker of Adult Multi-system Inflammatory Syndrome i.e. C-reactive Protein <br/ >Secondary Outcomes: Change in other markers of AMIS (Ferritin; D-dimer); Need for Ventilation (invasive or non-invasive); Mortality; Duration of Hospital Stay; Change in CT severity score at 1 month. <br/ >Timepoint: 4 month
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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 : Nov. 6, 2020, 11:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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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": 1468, "treatment_name": "Aspirin+colchicine+montelukast", "treatment_type": "Coagulation modifiers+metabolic agents+respiratory agents", "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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