Efficacy of Nebulized Lidocaine, Salbutamol, and Beclomethasone Plus Salbutamol in the Covid-19 Patients With ARDS on Non-invasive Ventilation; Randomized Control Trial

July 27, 2021 updated by: Sairah Sadaf, Sheikh Zayed Medical College
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

81

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Rahim Yar Khan, Punjab, Pakistan, 64200
        • Recruiting
        • Sheikh zayed medical college & hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Covid-19 positive
  • Moderate to severe ARDS

Exclusion Criteria:

  • patients with COPD or taking bronchodilators and steroids for chronic respiratory illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine group
Drug: Lidocaine
Lidocaine will be used for nebulization of the covid-19 patients and will be compared with other two drugs
Placebo Comparator: Salbutamol group
Drug: Lidocaine
Lidocaine will be used for nebulization of the covid-19 patients and will be compared with other two drugs
Active Comparator: Beclomethasone plus salbutamol
Drug: Lidocaine
Lidocaine will be used for nebulization of the covid-19 patients and will be compared with other two drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough suppression
Time Frame: within five minutes of initiation of treatment it will be assessed
it will be assessed by using cough severity score
within five minutes of initiation of treatment it will be assessed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correction of hypoxia
Time Frame: immediately before and after intervention
it will be assessed by PaO2
immediately before and after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Zayed Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 227/IRB/SZMC/SZH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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