Treatments of COVID-19 in primary care in the Netherlands

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Maastricht University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Decision date (initial)

2022-07-28

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

ZonMw

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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.

Conditions and MedDRA coding

Patients with COVID-19 in the community, referred by their general practitioner, who are at higher risk of a complicated illness course.

Regulatory references

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is time to recovery from suspected COVID-19 infection within 28 days from randomisation, defined as the first instance that a participant reports feeling recovered. This will be measured by means of a daily diary, where the participant records the answer to the question 'Do you feel fully recovered today? (i.e. symptoms associated with illness are no longer a problem)' with either yes or no.

Secondary endpoints 1

1. Secondary outcomes include: hospital admission; hospital assessment without admission; oxygen administration; intensive care unit admission; duration of severe symptoms; sustained recovery; contacts with the health services; consumption of antibiotics; WHO Well-being Index; daily rating of how well participants feels; Safety; Death

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Maastricht University

Sponsor organisation

Maastricht University

Address

P.o.box 616

City

Maastricht

Postcode

6200

Country

Netherlands

Scientific contact point

Organisation

Maastricht University

Contact name

Mark Spigt

Public contact point

Organisation

Maastricht University

Contact name

Mark Spigt

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications