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Trial - CTRI/2020/11/029170


Column Value
Trial registration number CTRI/2020/11/029170
Full text link
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Dr Praveen Talawar

Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

praveenrt64@gmail.com

Registration date
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-11-17

Recruitment status
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Blind label

Center
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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.

Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1.Refusal to participate in the study <br/ >2.Known allergy to lignocaine <br/ >3.Patient requiring invasive mechanical ventilation/Septic shock

Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

AIIMS Rishikesh

Inclusion age min
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

80

Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

India

Type of patients
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

60

primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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

Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (3.0) differs from found arms (4.0)

Phase
Last imported at : Dec. 16, 2020, 10:47 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"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"}]