Study on Montelukast for COVID-19 Patients at Higher Risk in Primary Care

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What is this study about?

This clinical trial is focused on studying treatments for COVID-19, a disease caused by the coronavirus that can lead to symptoms like shortness of breath, fever, and coughing. The trial is particularly interested in patients who are at a higher risk of experiencing severe illness. One of the treatments being tested is a medication called Montelukast, which is taken as a film-coated tablet. This medication is commonly used to manage allergies and asthma, and researchers are exploring its potential benefits for treating COVID-19.

The purpose of the study is to evaluate how effective these treatments are in helping patients recover more quickly from COVID-19. Participants in the study will be monitored over a period of time to see how their symptoms change and how long it takes for them to feel fully recovered. The study will also look at other important factors, such as whether patients need to be admitted to the hospital or require additional medical care.

Throughout the study, participants will be asked to keep a daily diary to record their recovery progress. This will help researchers understand the impact of the treatments on the patients’ health and quality of life. The study aims to provide valuable insights into how to better manage COVID-19 in the community, especially for those who are more vulnerable to severe outcomes.

1 joining the study

Upon joining the study, ensure that you have provided informed consent for participation. This means you understand the study and agree to take part.

Verify that you have a positive test for COVID-19 taken within the last 7 days and are experiencing symptoms such as shortness of breath, fever, or cough.

2 initial assessment

Participate in an initial assessment to confirm eligibility. This includes confirming your age and that you are eligible for the annual influenza vaccine if you are between 18-60 years old, or that you are aged 60 years or older.

3 medication administration

If eligible, you will be provided with Montelukast Sandoz 10 mg film-coated tablets. This medication is taken orally.

Follow the prescribed dosage and frequency as instructed by the study team. Ensure to take the medication as directed for the duration specified.

4 daily diary

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

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

5 monitoring and follow-up

Throughout the study, your health will be monitored. This includes tracking any hospital visits, oxygen administration, or changes in symptoms.

Regularly report any new symptoms or changes in your condition to the study team.

6 completion of study

At the end of the study period, a final assessment will be conducted to evaluate your recovery and any long-term symptoms.

Your participation will contribute to understanding the effectiveness of treatments for COVID-19 in primary care settings.

Who Can Join the Study?

The participant is willing and able to give informed consent for participation in the study. Informed consent means you understand the study and agree to take part.
The participant is willing and able to follow all the trial procedures.
The participant has an email address, mobile phone, and a device like a laptop, computer, or tablet that allows video calling.
The participant has a positive test for COVID-19. This test can be RT-PCR, LAMP, antigen, or a self-test, and it must have been taken fewer than 8 days ago (7 days or less).
The participant is experiencing symptoms of COVID-19. These symptoms may include shortness of breath, feeling unwell, muscle pain, sore throat, diarrhea, vomiting, fever, runny nose, sneezing, and coughing. The symptoms must have started 7 days ago or less.
The participant is aged between 18 and 60 years and is eligible for the annual flu vaccine.
The participant is aged 60 years or older.

Who Cannot Join the Study?

Patients who do not have symptomatic COVID-19. This means you must have symptoms of COVID-19 to participate.
Patients who are not at a higher risk of a complicated illness course. This means if you are not considered at higher risk for severe illness from COVID-19, you cannot participate.
Patients who are not in the community or primary care settings. This means you must be receiving care outside of a hospital setting.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Uexcjnadgkkb Matramfdae	Maastricht	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	02.01.2023

Trial locations

Investigated drugs:

Montelukast

Platform randomised trial of treatments for COVID-19 in general practice

Medication A is a treatment being tested to see if it can help people recover faster from COVID-19. It is given to patients who are at a higher risk of having a more severe illness. The goal is to find out if this medication can make the symptoms go away quicker and help patients feel better sooner.

Medication B is another treatment option in the trial. It is also aimed at helping patients with COVID-19 recover more quickly. This medication is being tested to see if it can reduce the time it takes for patients to get back to their normal health and activities.

Therapy C is a type of treatment that is not a medication but is being tested to see if it can help improve recovery times for COVID-19 patients. This therapy is designed to support the body’s natural healing process and help patients feel better faster.

Investigated diseases:

COVID-19

COVID-19 – COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. 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. Some individuals may experience gastrointestinal symptoms or loss of taste and smell. The progression of the disease varies, with some people recovering quickly while others may develop long-term symptoms. In severe cases, it can lead to complications requiring hospitalization and intensive care.

Trial ID:

2022-501559-99-00

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 in Primary Care

What is this study about?

Who Can Join the Study?

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