Study on Montelukast for COVID-19 Patients at Higher Risk of Complications in the Community

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What is this study about?

This clinical trial is focused on studying treatments for COVID-19 in patients who are at a higher risk of experiencing severe illness. The trial will explore the effectiveness of different treatments provided in primary care settings. One of the treatments being studied is a medication called Montelukast, which is taken as a film-coated tablet. This medication is commonly used to manage asthma and allergies by reducing inflammation in the airways.

The purpose of the study is to determine how well these treatments help patients recover from COVID-19. Participants in the study will be randomly assigned to receive either the treatment or usual care, which may include a placebo. The study will track the time it takes for participants to feel fully recovered from their symptoms, as well as other health outcomes such as hospital visits and overall well-being.

Throughout the study, participants will be asked to keep a daily diary to record their recovery progress. This will help researchers understand how the treatments impact recovery time and overall health. The trial aims to create a framework for future studies in primary care settings, not only for COVID-19 but also for other emerging diseases.

1 joining the study

Upon joining the study, you will be asked to provide informed consent. This means you agree to participate and understand the procedures involved.

You will need to confirm a positive test for SARS-CoV-2 infection, which is the virus that causes COVID-19. This test should have been taken fewer than 15 days ago, and you should be experiencing symptoms of COVID-19.

2 initial assessment

An initial assessment will be conducted to ensure you meet the criteria for the study. This includes being between 18-64 years old with certain health conditions or being 65 years or older.

Your symptoms and medical history will be reviewed to determine your eligibility.

3 treatment phase

If eligible, you will receive a treatment, which may include montelukast. This is a film-coated tablet taken orally.

The dosage is 10 mg, and it is taken once daily. The duration of administration will be specified by the study team.

4 daily diary

You will be asked to keep a daily diary to record your recovery progress. Each day, you will answer the question: ‘Do you feel fully recovered today?’ with a yes or no.

This diary helps track your recovery over a period of 28 days from the start of the treatment.

5 follow-up and monitoring

Throughout the study, your health will be monitored. This includes checking for any hospital admissions, oxygen administration, or other medical interventions.

Your overall well-being will be assessed using the WHO Well-being Index and other measures.

6 completion of the study

At the end of the study period, your participation will conclude. You will have a final assessment to review your health status and any outcomes related to the study.

The study aims to understand the effectiveness of treatments in reducing the time to recovery from COVID-19.

Who Can Join the Study?

The participant must be willing and able to give informed consent to join the study. This means they understand the study and agree to take part.
The participant must be willing to follow all the procedures of the trial.
The participant must have a positive test for SARS-CoV-2 infection (this is the virus that causes COVID-19). The test can be PCR, LAMP, antigen, or a self-test.
The positive test must have been taken fewer than 15 days ago.
The participant must be feeling unwell with symptoms of COVID-19, such as shortness of breath, general feeling of being unwell, muscle pain, diarrhea, vomiting, fever, or cough. These symptoms must have started fewer than 15 days ago.
Participants aged 18-64 years must have one of the following conditions that make them more vulnerable:
- Severe chronic problems with the airways and lungs, requiring treatment by a lung specialist.
- Chronic heart problems that make the participant eligible for the flu vaccine.
- Diabetes mellitus that is poorly controlled or has other related health issues.
- Severe kidney problems requiring dialysis or a kidney transplant.
- Reduced ability to fight infections due to autoimmune diseases, organ or stem cell transplants, blood diseases, lack of a spleen, severe immune disorders, or recent chemotherapy.
- Untreated HIV infection or an HIV infection with a CD4 count higher than 200.
- Severe liver disease classified as Child-Pugh B or C.
- Morbid obesity (a body mass index, BMI, greater than 40).
Participants aged 65 years or older can join the study without needing to have any of the above conditions.

Who Cannot Join the Study?

Patients who do not have COVID-19.
Patients who are not referred by their general practitioner (family doctor).
Patients who are not at a higher risk of a complicated illness course (meaning their illness is not expected to become severe).
Patients who are not part of the age groups specified for the study.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population (groups that may need special protection or care).

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ulnthhbpgzol Mwdlwljqlf	Maastricht	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.10.2022

Trial locations

Investigated drugs:

Montelukast

PLATFORM-COVID study is a clinical trial that aims to evaluate the effectiveness of different treatments for COVID-19 in patients who are at higher risk of severe illness. The trial is conducted in general practice settings, meaning it takes place in local healthcare facilities rather than hospitals. The goal is to find out which treatments help patients recover faster from COVID-19. The study also aims to create a system that can be used for future research on COVID-19 and other new diseases in the community.

Unfortunately, the specific medications or therapies being tested in this trial are not listed in the provided data. If you have more information or specific names of the treatments being studied, I can help describe them further.

COVID-19 – COVID-19 is a respiratory illness caused by the coronavirus SARS-CoV-2. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The disease can start with mild symptoms such as fever, cough, and fatigue, but it may progress to more severe conditions like difficulty breathing and pneumonia. In some cases, it can lead to complications affecting other organs, including the heart and kidneys. The progression of symptoms can vary widely among individuals, with some experiencing mild illness and others developing severe symptoms. Recovery times also differ, with some people recovering quickly and others experiencing prolonged symptoms.

Trial ID:

2022-500678-33-00

Protocol code:

NL79504.068.21

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Montelukast for COVID-19 Patients at Higher Risk of Complications in the Community

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?