Covid19NCT04714515
Montelukast - a Treatment Choice for COVID-19
An observational study of Covid19 and SARS-CoV-2 Infection, run by University of Sargodha at 2 sites in 2 countries.
Trial summary
The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the standard of care. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Covid19, SARS-CoV-2 Infection
- What is being tested?
- Montelukast, Hydroxychloroquine and Ivermectin
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Feb 2020to 20 Apr 2020
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, who were admitted to the hospitals with SARS-CoV-2 contacts (environmental exposure or close contact) or obvious COVID-19 symptoms and were diagnosed with COVID-19 using the PCR tests. Consent was obtained from all patients with a detailed history of any known co-morbidities.
Who may be able to join
- Patients with diagnosed COVID-19
- Patients who are not directly admitted to ICU
Who cannot join
- Patients, who were already on immunosuppressants
- Patients with age > 80
- Patient with any known allergies to montelukast
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
Shanghai
Pakistan1 site
Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan
Lahore, Punjab Province, 54600
About this study
Official title: Using Montelukast to Treat the Patients Infected With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the standard of care. The safety and efficacy of HCQ and ML will be assessed as individual therapy and in combination with each other and with the standard of care. Cytokine storm (Interleukin levels) also will be monitored throughout the study to assess treatment progression.
Read the detailed description
To date, no specific medication is available for COVID-19. Many FDA-approved drugs, including antivirals, antibacterials, and anti-inflammatory compositions are being tested with the intention of repurposing against COVID-19. In this study, investigators have evaluated the effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in an individual and combination therapy.
Investigators have performed an observational study of 100 hospitalized COVID-19 patients while assessing the safety and efficacy of HCQ, ML, and IV as individual therapy and in combination with each other. ECG, interleukin levels, LFTs, blood profiles were continuously monitored throughout the study.
The aim was to observe participants treated with ML and monitor the inflammatory markers to see whether they increase or decrease and whether an increase in survival rate is observed. The findings have shown that combinational therapy of ML with continuous observation of liver/kidney profiles and QTc prolongation can provide robust recovery with suppression of cytokines.
- Conditions
- Covid19, SARS-CoV-2 Infection
- Being tested
- Montelukast, Hydroxychloroquine, Ivermectin
- Keywords
- COVID-19, Montelukast
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
An FDA approved medicine to treat asthmatic patients
An FDA approved antiarthritis drug
IvermectinDrug
An FDA approved anti-parasitic medicine
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine and Montelukast | Group 1 was given Standard of care (SOC) + HCQ + Montelukast Receives: Drug: Montelukast; Drug: Hydroxychloroquine | |
| Montelukast | Group 2 was given Standard of care (SOC) + Montelukast Receives: Drug: Montelukast | |
| Hydroxychloroquine | Group 3 was given Standard of care (SOC) + HCQ Receives: Drug: Hydroxychloroquine | |
| Hydroxychloroquine, Montelukast and Invermectin | Group 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin Receives: Drug: Montelukast; Drug: Hydroxychloroquine; Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients admittance to ICU
Changes in the number of ICU visits of COVID-19 patients
Measured: 2 Week
Length of total stay at the hospital
Changes in the length of total stay of patients at the hospital
Measured: 2 weeks
Alleviating the symptoms of COVID-19
Monitoring the changes in disease severity with alleviation of the symptoms
Measured: 2 weeks
Secondary outcomes (1)
Interleukin levels
Monitoring the Interleukin levels with the progression of treatments
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start20 Feb 2020
- Primary completion30 Mar 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sargodha
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shaukat Khanum Memorial Cancer Hospital & Research Centre, Shanghai Jiao Tong University School of Medicine, Teesside University
- Responsible party
- Principal investigator, Muhammad Fayyaz ur Rehman, University of Sargodha
- Investigators
- Wei Zhang, MD, Principal investigator, Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, ChinaMuhammad Rehman Akram, MBBS, Principal investigator, Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714515
- Sponsor's protocol ID
- 01032020-7
- Status last verified
- Jan 2021
- First submitted
- 19 Sep 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Montelukast to Treat the Patients Infected With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- ClinicalTrials.gov ID
- NCT04714515
- Acronym / sponsor ID
- 01032020-7
- Conditions
- Covid19, SARS-CoV-2 Infection
- Keywords
- COVID-19, Montelukast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of SargodhaUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shaukat Khanum Memorial Cancer Hospital & Research Centre, Shanghai Jiao Tong University School of Medicine, Teesside University
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 19 Jan 2021 (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.
The current study aimed to make a therapeutic comparison and effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in COVID-19 patients in addition to the standard of care. The safety and efficacy of HCQ and ML will be assessed as individual therapy and in combination with each other and with the standard of care. Cytokine storm (Interleukin levels) also will be monitored throughout the study to assess treatment progression.
Detailed description
To date, no specific medication is available for COVID-19. Many FDA-approved drugs, including antivirals, antibacterials, and anti-inflammatory compositions are being tested with the intention of repurposing against COVID-19. In this study, investigators have evaluated the effectiveness of Hydroxychloroquine (HCQ) and Montelukast (ML) in an individual and combination therapy.
Investigators have performed an observational study of 100 hospitalized COVID-19 patients while assessing the safety and efficacy of HCQ, ML, and IV as individual therapy and in combination with each other. ECG, interleukin levels, LFTs, blood profiles were continuously monitored throughout the study.
The aim was to observe participants treated with ML and monitor the inflammatory markers to see whether they increase or decrease and whether an increase in survival rate is observed. The findings have shown that combinational therapy of ML with continuous observation of liver/kidney profiles and QTc prolongation can provide robust recovery with suppression of cytokines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine and Montelukast | – | Drug: Montelukast, Drug: HydroxychloroquineGroup 1 was given Standard of care (SOC) + HCQ + Montelukast |
| Montelukast | – | Drug: MontelukastGroup 2 was given Standard of care (SOC) + Montelukast |
| Hydroxychloroquine | – | Drug: HydroxychloroquineGroup 3 was given Standard of care (SOC) + HCQ |
| Hydroxychloroquine, Montelukast and Invermectin | – | Drug: Montelukast, Drug: Hydroxychloroquine, Drug: IvermectinGroup 4 was given Standard of care (SOC) + Montelukast + HCQ and Ivermectin |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, who were admitted to the hospitals with SARS-CoV-2 contacts (environmental exposure or close contact) or obvious COVID-19 symptoms and were diagnosed with COVID-19 using the PCR tests. Consent was obtained from all patients with a detailed history of any known co-morbidities.
Key inclusion criteria (2 listed)
- Patients with diagnosed COVID-19
- Patients who are not directly admitted to ICU
Key exclusion criteria (3 listed)
- Patients, who were already on immunosuppressants
- Patients with age > 80
- Patient with any known allergies to montelukast
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 |
|---|---|---|
| MontelukastAn FDA approved medicine to treat asthmatic patients | Drug | Hydroxychloroquine and Montelukast, Hydroxychloroquine, Montelukast and Invermectin, Montelukast |
| HydroxychloroquineAn FDA approved antiarthritis drug | Drug | Hydroxychloroquine, Hydroxychloroquine and Montelukast, Hydroxychloroquine, Montelukast and Invermectin |
| IvermectinAn FDA approved anti-parasitic medicine | Drug | Hydroxychloroquine, Montelukast and Invermectin |
Primary outcome
Patients admittance to ICU
Time frame: 2 Week
Changes in the number of ICU visits of COVID-19 patients
Length of total stay at the hospital
Time frame: 2 weeks
Changes in the length of total stay of patients at the hospital
Alleviating the symptoms of COVID-19
Time frame: 2 weeks
Monitoring the changes in disease severity with alleviation of the symptoms
1 secondary outcome
Interleukin levels
Time frame: 1 Week
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 19 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Wei Zhang, MD principal investigator
Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
Muhammad Rehman Akram, MBBS principal investigator
Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and SARS-CoV-2 Infection, run by University of Sargodha at 2 sites in 2 countries.
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 2 inclusion and 3 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 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Pakistan. 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?
Patients admittance to ICU (time frame: 2 Week). The study lists 3 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 19 Jan 2021.