Overview
Sponsor-declared trial summary
Patients with symptomatic COVID-19 in the community and in primary care, who are at higher risk of a complicated illness course.
To assess the effectiveness of treatments provided on time to recovery amongst patients with COVID-19 in the community who are at higher risk of a complicated course of disease.
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]
- Trial duration
- 25 May 2023 → 1 Nov 2023
- Decision date (initial)
- 2023-03-06
- 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
To assess the effectiveness of treatments provided on time to recovery amongst patients with COVID-19 in the community who are at higher risk of a complicated course of disease.
Conditions and MedDRA coding
Patients with symptomatic COVID-19 in the community and in primary care, who are at higher risk of a complicated illness course.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10084268 | COVID-19 | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Participant is willing and able to give informed consent for participation in the study.
- Participant is willing and able to comply with all trial procedures.
- Participant has an e-mail address, mobile phone and a laptop/computer/tablet that allows video calling.
- A positive test for COVID-19 (can be either RT-PCR, LAMP, antigen or self-test), which was taken fewer than 8 days ago (7 days or less).
- The participant experiences symptoms of COVID-19. These symptoms may include, but are not limited to, shortness of breath, general feeling of being unwell, muscle pain, sore throat, diarrhoea, vomiting, fever, running nose, sneezing and coughing, and they must have had them for 7 days or less.
- Patients aged ≥18-60 years who are eligible for the annual influenza vaccine.
- Patients aged ≥60 years
Exclusion criteria 5
- Currently admitted to hospital
- Almost recovered (generally much improved and symptoms now mild or almost absent)
- Intervention specific (Montelukast): Known hypersensitivity to montelukast
- Intervention specific (Montelukast): Concomitant use of montelukast
- Intervention specific (Montelukast): Using Fenytoine, Fenobarbital, Rifampicine, Carbamazepine or St John’s wort
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 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 14
- 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
- quality of life
- daily rating of how well participant feels
- safety
- death
- long term symptoms
- post-COVID-19 functional status
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Montelukast Sandoz 10 MG, Filmomhulde Tabletten
PRD768743 · Product
- Active substance
- Montelukast
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- R03DC03 — MONTELUKAST
- Marketing authorisation
- RVG 102885
- MA holder
- SANDOZ B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Maastricht University
- Sponsor organisation
- Maastricht University
- Address
- Minderbroedersberg 4-6
- City
- Maastricht
- Postcode
- 6211 LK
- 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
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 682 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2023-05-25 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-3316
- Halt date
- 2023-07-25
- Planned restart
- 2023-10-01
- Member states concerned
- Netherlands
- Publication date
- 2023-07-25
- Reason
- Feasibility (recruitment issues etc.), Sponsor decision, Reprioritisation of trial
- Explanation
- there a too less COVID-19 infections at the moment
- Follow-up measures
- there are no subjects included
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-05 | Netherlands | Acceptable 2023-03-06
|
2023-03-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-03-16 | Netherlands | Acceptable 2023-06-15
|
2023-06-15 |