Back to resultsValue of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough
Primary Purpose
Post COVID-19
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Montelukast Sodium Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Post COVID-19 focused on measuring Montelukast, cough, cough severity
Eligibility Criteria
Inclusion Criteria:
- Patients with Post COVID-19 persistent cough after 4 weeks of acute attack
Exclusion Criteria:
- Any contraindication to Montelukast, respiratory, cardiac disease, pregnancy, breastfeeding and use of angiotensin converting enzyme inhibitors.
Sites / Locations
- Aliae Mohamed-Hussein
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Montelukast treated
Standard treatment
Arm Description
Outcomes
Primary Outcome Measures
cough severity index
Scale from mild to severe
Cough severity visual analog
Severity from 0-10
Secondary Outcome Measures
Side effects of drug
Nausea, vomiting, abdominal pain, restlessness, depression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05447039
Brief Title
Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough
Official Title
Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough: A Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
As of September 2020, the COVID-19 pandemic has affected millions of people in 196 countries and left hundreds of thousands dead. After recovery it was found that up to 32% of cases had 1 or 2 symptoms, 55% had 3 or more Post-COVID-19 symptoms, and persistent Post COVID-19 cough was recorded in 29.3% of cases in one study.
A recent study identified Montelukast, among the top-scoring clinically-oriented drugs likely to inhibit SARS-CoV-2 main protease. Besides its known effect that is reported to improve cough and prevent exercise-induced bronchoconstriction in asthma, many trials assessed Montelukast in the treatment of post-infectious cough and found variable effects.
Despite that the exact mechanism is not yet identified, Barré and colleagues proposed several properties of Cyst LT1 receptor antagonists that are potentially beneficial in COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post COVID-19
Keywords
Montelukast, cough, cough severity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Montelukast treated
Arm Type
Active Comparator
Arm Title
Standard treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Montelukast Sodium Tablets
Other Intervention Name(s)
Montelukast
Intervention Description
intervention group received standard cough therapy+ Montelukast 10 mg/day for 14 days
Primary Outcome Measure Information:
Title
cough severity index
Description
Scale from mild to severe
Time Frame
14 days
Title
Cough severity visual analog
Description
Severity from 0-10
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Side effects of drug
Description
Nausea, vomiting, abdominal pain, restlessness, depression
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Post COVID-19 persistent cough after 4 weeks of acute attack
Exclusion Criteria:
Any contraindication to Montelukast, respiratory, cardiac disease, pregnancy, breastfeeding and use of angiotensin converting enzyme inhibitors.
Facility Information:
Facility Name
Aliae Mohamed-Hussein
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
upon reasonable request
Learn more about this trial
Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough
We'll reach out to this number within 24 hrs