Not Authorised Therapeutic use (Phase IV) Patients with COVID-19 in the community, referred by their general practitioner, who are at higher risk of a complicated illness course.

Treatments of COVID-19 in primary care in the Netherlands

EU CTIS ID: 2022-500678-33-00

What this study is testing

1. To assess the effectiveness of treatments provided in primary care on time to recovery amongst patients with COVID-19 in the community who are at higher risk of a complicated illness course. 2. To embed the platform trial in Dutch primary care, creating a standing infrastructure for future nationwide trials in primary care for COVID-19, and other emerging diseases. Interventions to be studied: during a platform trial multiple interventions can be included. Interventions will be compared with care as usual.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Participant is willing and able to give informed consent for participation in the study; • Participant is willing to comply with all trial procedures; • A positive test for SARS-Co-V2 infection (can be PCR, LAMP, antigen or self-test) [10], which was taken fewer than 15 days ago, AND the participant is unwell with symptoms of COVID-19. These symptoms may include, but are not limited to, shortness of breath, general feeling of being unwell, muscle pain, diarrhoea, vomiting, fever and cough, and they must have had them for fewer than 15 days. • Patients aged ≥18-64 years with any of the following listed comorbidities (which makes them more vulnerable, and for which they receive or have received treatment): • Chronic disruptions and function loss of the airways and lungs, which are severe enough to be treated by a pulmonologist. • Chronic disorder of the heart function, which makes the patient eligible for the influenza vaccination. • Diabetes mellitus: poorly controlled diabetes or diabetes with secondary comorbidities. • Severe kidney dysfunction which requires dialysis or kidney transplantation. • Reduced immunity to infections due to auto-immune diseases, after organ or stemcel transplantation, hematological diseases, Asplenia, severe immune disorders present at birth or developed later in life, which require treatment or during and within 3 months of chemotherapy. • Untreated HIV-infection or an HIV infection with a CD4 higher than 200. • Severe liver disease in Child-Pugh classification B or C. • Morbid obesity (BMI>40). • Patients aged ≥65

You likely can't join if

  • Patients currently admitted to hospital • Almost recovered (generally much improved and symptoms now mild or almost absent) • Known hypersensitivity to montelukast • Concomitant use of montelukast

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.