Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-speranza COVID-19 Project study protocol

ABSTRACT

Objective: To evaluate the efficacy of 10-mg oral montelukast every 24 h for 28 days versus placebo in improving health-related quality of life in patients with long COVID and mild to moderate respiratory symptoms measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity and oxygen desaturation;COVID-19 related symptoms (asthenia, headache, mental, brain fog, ageusia and anosmia);functional status;and mortality. Material and/or methods: Phase III, randomized, double-blind clinical trial. We will include 18 to 80 year old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting between 4 weeks and 12 months after the onset of infection. Participants will be randomly allocated in a 11 ratio to the experimental treatment with 10-mg/day montelukast or the placebo group, during a 28-day treatment. Follow-up will finish 56 days after starting of the treatment. The study will be carried out in primary healthcare centres in four health areas of Catalonia and Aragon, Spain, from 1 August 2021 to 1 March 2023. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test, assessed at 4 weeks after finishing of the treatment. Secondary outcomes: (a) Exercise capacity and oxygen saturation (1Min Sit-to-Stand test);(b) Post-COVID-19 Functional Status scale;(c) other symptoms asthenia, headache, mental confusion (brain fog), ageusia and anosmia (Likert scale);(d) use of healthcare resources;(e) sick leave duration in days;(f) side effects of montelukast;(g) mortality. Ethics and dissemination This study has been approved by the AEMPS and Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). EudraCT number 2021-000605-24. ClinicalTrials.gov Identifier NCT04695704.It is currently under peer-review process for publication. Results: Ongoing clinical trial. Conclusions: Ongoing clinical trial.