Back to resultsEfficacy of Nebulized Lidocaine, Salbutamol, and Beclomethasone Plus Salbutamol in the Covid-19 Patients With ARDS on Non-invasive Ventilation; Randomized Control Trial
Primary Purpose
COVID-19 Acute Respiratory Distress Syndrome
Status
Unknown status
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19 Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- Covid-19 positive
- Moderate to severe ARDS
Exclusion Criteria:
- patients with COPD or taking bronchodilators and steroids for chronic respiratory illnesses
Sites / Locations
- Sheikh zayed medical college & hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Lidocaine group
Salbutamol group
Beclomethasone plus salbutamol
Arm Description
Outcomes
Primary Outcome Measures
Cough suppression
it will be assessed by using cough severity score
Secondary Outcome Measures
correction of hypoxia
it will be assessed by PaO2
Full Information
NCT ID
NCT04979923
First Posted
July 27, 2021
Last Updated
July 27, 2021
Sponsor
Sheikh Zayed Medical College
1. Study Identification
Unique Protocol Identification Number
NCT04979923
Brief Title
Efficacy of Nebulized Lidocaine, Salbutamol, and Beclomethasone Plus Salbutamol in the Covid-19 Patients With ARDS on Non-invasive Ventilation; Randomized Control Trial
Official Title
Efficacy of Nebulized Lidocaine, Salbutamol, and Beclomethasone Plus Salbutamol in the Covid-19 Patients With ARDS on Non-invasive Ventilation; Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheikh Zayed Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The COVID-19, a pandemic as declare by WHO1, has a devastating impact on health and economic worldwide2. Literature suggests that acute respiratory distress syndrome (ARDS) develops over 20% of the infected individuals with Coivd-pneumonia3 along with other symptoms like fever followed by cough and dyspnea as well as chest pain in severe cases4. The current preventative strategies are non-specific10, and current interventions are predominantly supportive1. Recently, some studies have demonstrated anti-inflammatory actions for local anesthetics including lidocaine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine group
Arm Type
Experimental
Arm Title
Salbutamol group
Arm Type
Placebo Comparator
Arm Title
Beclomethasone plus salbutamol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine will be used for nebulization of the covid-19 patients and will be compared with other two drugs
Primary Outcome Measure Information:
Title
Cough suppression
Description
it will be assessed by using cough severity score
Time Frame
within five minutes of initiation of treatment it will be assessed
Secondary Outcome Measure Information:
Title
correction of hypoxia
Description
it will be assessed by PaO2
Time Frame
immediately before and after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Covid-19 positive
Moderate to severe ARDS
Exclusion Criteria:
patients with COPD or taking bronchodilators and steroids for chronic respiratory illnesses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sairah s sadaf, FCPS
Phone
0092 689230165
Ext
245
Email
sairahbabar@live.com
Facility Information:
Facility Name
Sheikh zayed medical college & hospital
City
Rahim Yar Khan
State/Province
Punjab
ZIP/Postal Code
64200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
alina a umar, MCPS
Phone
0092 689230165
Ext
245
Email
alinaumar1@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Nebulized Lidocaine, Salbutamol, and Beclomethasone Plus Salbutamol in the Covid-19 Patients With ARDS on Non-invasive Ventilation; Randomized Control Trial
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