Platform randomised trial of treatments for COVID-19 in general practice

The primary objective of this study is to assess the **effectiveness** of treatments administered to patients with COVID-19 in the community, specifically focusing on those at higher risk of a complicated disease course. This evaluation is crucial as it aims to determine the impact of timely treatment on the recovery time of these patients, potentially reducing the severity and duration of the illness. The study is conducted in a primary care setting, which is significant for understanding the management of COVID-19 outside of hospital environments.

The clinical trial involves **patients with symptomatic COVID-19** who are at higher risk of a complicated illness course. The study population includes both male and female participants, aged 18 years and older, with a specific focus on those eligible for the annual influenza vaccine. Participants are required to have a positive COVID-19 test taken within the last 7 days and must be experiencing symptoms such as shortness of breath, muscle pain, or fever, among others. The trial does not target a vulnerable population specifically. The sponsor has not provided information regarding the total number of participants. Selection criteria include the ability to give informed consent and comply with trial procedures, as well as access to necessary technology for video calling. Lifestyle factors such as diet and physical activity are not specified as part of the selection process.

The clinical trial is designed to evaluate the **effectiveness** of treatments for patients with symptomatic **COVID-19** in the community who are at higher risk of a complicated illness course. This is a randomized, double-blind, controlled trial with an estimated duration from January 2, 2023, to December 29, 2023. The trial involves the administration of **Montelukast Sandoz 10 mg** film-coated tablets, taken orally, with a maximum daily dose of 10 mg and a total treatment period of up to 10 days. The primary endpoint is the time to recovery within 28 days from randomization, defined as the first instance a participant reports feeling fully recovered. Secondary endpoints include hospital admission, oxygen administration, and quality of life, among others.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as a positive COVID-19 test taken within the last 7 days and the presence of symptoms. Follow-up visits will be conducted to monitor progress and collect data on recovery and any adverse events. The end-of-study visit will assess the overall health status and any long-term symptoms. The expected length of participant involvement is approximately 28 days, with conditions for early termination including withdrawal of consent or non-compliance with trial procedures. Participants must be aged 18 years or older and eligible for the annual influenza vaccine. The trial is categorized as a phase IV study, indicating it is a low-intervention trial focused on post-marketing surveillance of the treatment's effectiveness and safety.

The clinical trial involves the administration of **Montelukast Sandoz 10 mg**, a **film-coated tablet** containing the active substance **montelukast**. This medication is chemically synthesized and is provided in the form of film-coated tablets for oral administration. The dosage regimen for the trial specifies a maximum daily dose of 10 mg, with a total maximum dose of 100 mg over the course of the treatment period. The treatment duration is set for a maximum of 10 days. Participants are required to take the medication orally, adhering to the prescribed dosage and schedule to ensure compliance and accurate assessment of the treatment's efficacy.

In this trial, **Montelukast Sandoz** is the experimental treatment being evaluated for its effectiveness in improving recovery time among patients with COVID-19 who are at higher risk of a complicated disease course. There are no non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, mentioned in the trial documentation. Compliance with the dosing schedule is monitored to ensure that participants adhere to the treatment protocol, which is crucial for the integrity of the trial results.

Efficacy in this clinical trial will be assessed primarily through the measurement of time to recovery from suspected COVID-19 infection within 28 days from randomization. This primary endpoint is defined as the first instance that a participant reports feeling recovered, which will be captured using a daily diary. Participants will record their response to the question, "Do you feel fully recovered today? (i.e., symptoms associated with illness are no longer a problem)" with a yes or no answer.

Secondary endpoints include a range of clinical outcomes and patient-reported measures. These encompass hospital admission, hospital assessment without admission, oxygen administration, Intensive Care Unit admission, duration of severe symptoms, sustained recovery, contacts with health services, consumption of antibiotics, quality of life, daily rating of how well the participant feels, safety, death, long-term symptoms, and post-COVID-19 functional status. These parameters will be systematically collected and analyzed to provide a comprehensive evaluation of the treatment's efficacy.