Trial registration number
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CTRI/2020/11/029170 |
Full text link
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49412
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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 Praveen Talawar
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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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praveenrt64@gmail.com
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Registration date
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-11-17
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Recruitment status
Last imported at : Dec. 16, 2020, 10:47 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 : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Dec. 16, 2020, 10:47 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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Patients with PCR documented Covid -19 infection with respiratory distress(presence of hypoxia with Spo2 <93% or radiographic evidence of pneumonia,any single organ failure,sepsis)requiring supplemental oxygenation or non-invasive mechanical ventilation.
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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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1.Refusal to participate in the study <br/ >2.Known allergy to lignocaine <br/ >3.Patient requiring invasive mechanical ventilation/Septic shock
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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 : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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AIIMS Rishikesh
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Inclusion age min
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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80
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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 : Dec. 16, 2020, 10:47 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 : Dec. 16, 2020, 10:47 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 : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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60
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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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1.Oxygenation improvement as measured by Spo2 and ABG <br/ >2.Duration of supplemental oxygen requirement <br/ >3.Decrease in the need for invasive mechanical ventilation.Timepoint: Patient is improved or getting worse to receive mechanical ventilation or death. <br/ >Monitored on daily basis while on receiving study intervention <br/ >till the study period <br/ > <br/ >the study ends after patient improvement or worsens to mechanical ventilation
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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 (3.0)
differs from found arms (4.0)
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Phase
Last imported at : Dec. 16, 2020, 10:47 a.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": 733, "treatment_name": "Lidocaine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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