NCT05447039

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 3, 2022

Last Update Submit

July 5, 2022

Conditions

Post COVID-19

Keywords

Montelukastcoughcough severity

Outcome Measures

Primary Outcomes (2)

  • cough severity index

    Scale from mild to severe

    14 days

  • Cough severity visual analog

    Severity from 0-10

    14 days

Secondary Outcomes (1)

  • Side effects of drug

    14 days

Study Arms (2)

Montelukast treated

ACTIVE COMPARATOR
Drug: Montelukast Sodium Tablets

Standard treatment

NO INTERVENTION

Interventions

Montelukast Sodium TabletsDRUG

intervention group received standard cough therapy+ Montelukast 10 mg/day for 14 days

Also known as: Montelukast
Montelukast treated

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Post COVID-19 persistent cough after 4 weeks of acute attack

You may not qualify if:

  • Any contraindication to Montelukast, respiratory, cardiac disease, pregnancy, breastfeeding and use of angiotensin converting enzyme inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aliae Mohamed-Hussein

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Cough

Interventions

montelukast

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pulmonology

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 7, 2022

Study Start

September 1, 2020

Primary Completion

November 30, 2020

Study Completion

March 30, 2021

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations

EG(1)