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

• Sponsor: Sheikh Zayed Medical College (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04979923
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 1
• Patients Per Site Per Month: 79.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Respiratory Distress Syndrome	Drug: Lidocaine	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Jul 31, 2021
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cough suppression [within five minutes of initiation of treatment it will be assessed]

   it will be assessed by using cough severity score

Secondary Outcome Measures

1. correction of hypoxia [immediately before and after intervention]

   it will be assessed by PaO2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Covid-19 positive

• Moderate to severe ARDS

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheikh zayed medical college & hospital	Rahim Yar Khan	Punjab	Pakistan	64200

Sponsors and Collaborators

• Sheikh Zayed Medical College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sairah Sadaf, Associate Professor, Sheikh Zayed Medical College
• ClinicalTrials.gov Identifier: NCT04979923
• Other Study ID Numbers: 227/IRB/SZMC/SZH
• First Posted: Jul 28, 2021
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lidocaine

Study Results

No Results Posted as of Jul 28, 2021