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Efficacy 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
Sheikh Zayed Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 Acute Respiratory Distress Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 27, 2021
Last Updated
July 27, 2021
Sponsor
Sheikh Zayed Medical College
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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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