The coronavirus disease-2019 (COVID-19) pandemic continues to affect the globe. After eighteen months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown and evidence-based, effective treatments for this condition remain unavailable. Objectives
To evaluate the efficacy of 10 mg oral montelukast every 24 hours versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving: exercise capacity; COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia); oxygen desaturation during exertion; functional status; and mortality.
Methods and analysis
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 more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow up will finish 56 days after start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting 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) Mortality; f) Sick leave duration in days g) Side effects of montelukast.
Ethics and dissemination
This study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals.
ClinicalTrials.gov Identifier: NCT04695704 first posted on January, 5, 2021. EudraCT number 2021-000605-24). Prospectively registered.