Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough

Post COVID-19 Clinical Trial

Official title:

Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447039
• Other study ID #: AssiutU21-1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 30, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Post COVID-19

Intervention

Drug:
• Montelukast Sodium Tablets
intervention group received standard cough therapy+ Montelukast 10 mg/day for 14 days

Locations

Country	Name	City	State
Egypt	Aliae Mohamed-Hussein	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cough severity index	Scale from mild to severe	14 days
Primary	Cough severity visual analog	Severity from 0-10	14 days
Secondary	Side effects of drug	Nausea, vomiting, abdominal pain, restlessness, depression	14 days