NCT04979923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

July 27, 2021

Last Update Submit

July 27, 2021

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • Cough suppression

    it will be assessed by using cough severity score

    within five minutes of initiation of treatment it will be assessed

Secondary Outcomes (1)

  • correction of hypoxia

    immediately before and after intervention

Study Arms (3)

Lidocaine group

EXPERIMENTAL
Drug: Lidocaine

Salbutamol group

PLACEBO COMPARATOR
Drug: Lidocaine

Beclomethasone plus salbutamol

ACTIVE COMPARATOR
Drug: Lidocaine

Interventions

LidocaineDRUG

Lidocaine will be used for nebulization of the covid-19 patients and will be compared with other two drugs

Beclomethasone plus salbutamolLidocaine groupSalbutamol group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Covid-19 positive
  • Moderate to severe ARDS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh zayed medical college & hospital

Rahim Yar Khan, Punjab Province, 64200, Pakistan

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

sairah s sadaf, FCPS

CONTACT

0092 689230165sairahbabar@live.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 27, 2021

First Posted

July 28, 2021

Study Start

July 1, 2021

Primary Completion

July 31, 2021

Study Completion

August 1, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations

PA(1)