Post COVID-19NCT05447039
Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough
A study testing Montelukast Sodium Tablets in people with Post COVID-19, run by Assiut University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post COVID-19
- What is being tested?
- Montelukast Sodium Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Post COVID-19 persistent cough after 4 weeks of acute attack
Who cannot join
- Any contraindication to Montelukast, respiratory, cardiac disease, pregnancy, breastfeeding and use of angiotensin converting enzyme inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough: A Randomized Controlled Pilot Study
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.
- Conditions
- Post COVID-19
- Being tested
- Montelukast Sodium Tablets
- Keywords
- Montelukast, cough, cough severity
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast Sodium TabletsDrug
Also called Montelukast
intervention group received standard cough therapy+ Montelukast 10 mg/day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Montelukast treated | Active comparator | Not described Receives: Drug: Montelukast Sodium Tablets |
| Standard treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough severity index
Scale from mild to severe
Measured: 14 days
Cough severity visual analog
Severity from 0-10
Measured: 14 days
Secondary outcomes (1)
Side effects of drug
Nausea, vomiting, abdominal pain, restlessness, depression
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Sep 2020
- Primary completion30 Nov 2020
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447039
- Sponsor's protocol ID
- AssiutU21-1
- Status last verified
- Jul 2022
- First submitted
- 3 Jul 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Montelukast as a Potential Treatment of Post COVID-19 Persistent Cough: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05447039
- Acronym / sponsor ID
- AssiutU21-1
- Conditions
- Post COVID-19
- Keywords
- Montelukast, cough, cough severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast treated | Active comparator | Drug: Montelukast Sodium Tablets |
| Standard treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Post COVID-19 persistent cough after 4 weeks of acute attack
Key exclusion criteria (1 listed)
- Any contraindication to Montelukast, respiratory, cardiac disease, pregnancy, breastfeeding and use of angiotensin converting enzyme inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast Sodium TabletsAlso: Montelukastintervention group received standard cough therapy+ Montelukast 10 mg/day for 14 days | Drug | Montelukast treated |
Primary outcome
cough severity index
Time frame: 14 days
Scale from mild to severe
Cough severity visual analog
Time frame: 14 days
Severity from 0-10
1 secondary outcome
Side effects of drug
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: Undecided. upon reasonable request
Related trials for Post COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast Sodium Tablets in people with Post COVID-19, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cough severity index (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.