Treatments of COVID-19 in primary care in the Netherlands

Phase 1

• Conditions: Patients with COVID-19 in the community, referred by their general practitioner, who are at higher risk of a complicated illness course.; MedDRA version: 23.0Level: LLTClassification code: 10084355Term: COVID-19 virus test positive Class: 10022891; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2022-500678-33-00
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified