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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

3 criteria

  • 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.
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Investigated drugs

  • Ibuprofen

    Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used to reduce pain, inflammation and fever. In this clinical trial, its effectiveness is being investigated in the treatment of patients with COVID-19 to relieve symptoms and improve recovery time.

  • Azithromycin

    Azithromycin is an antibiotic used to treat various bacterial infections. In the context of this trial, its use in patients with COVID-19 is being evaluated to determine whether it can help prevent complications and speed up recovery.

  • Doxycycline

    Doxycycline is another type of antibiotic used to treat bacterial infections. In this study, its effectiveness is being tested in patients with COVID-19 to see whether it can reduce the severity of the disease and improve recovery time.

  • Colchicine

    Colchicine is a medication mainly used to treat gout and other inflammatory conditions. In this trial, its potential to reduce inflammation in patients with COVID-19 and improve their recovery is being investigated.

  • Budesonide

    Budesonide is a corticosteroid used to treat asthma and other respiratory diseases. In this study, its use in patients with COVID-19 is being evaluated to see whether it can help reduce respiratory symptoms and speed up recovery.

What is already known about the treatment

Montelukast – Montelukast is a well-known medicine taken by mouth as a film-coated tablet, usually once daily in the evening. It has been used for many years to prevent asthma attacks and to relieve allergic rhinitis, and in this trial it is being tested as a possible treatment for COVID-19 in patients at higher risk of complications. It works by blocking receptors for leukotrienes, natural substances that cause the airways to narrow, swell and produce mucus; blocking them reduces inflammation and keeps the airways open. It is classified as a leukotriene receptor antagonist.

Investigated diseases

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 detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501559-99-00Protocol codeNL79504.068.21Estimated enrolment682 patientsSponsorUniversiteit Maastricht

sourced from the EU Clinical Trials Register and site verification

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