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 Project study protocol

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; p. 19
• Main Authors: Mera-Cordero, Francisco, Bonet-Monne, Sara, Almeda-Ortega, Jesús, García-Sangenís, Ana, Cunillera-Puèrtolas, Oriol, Contreras-Martos, Sara, Alvarez-Muñoz, Gemma, Monfà, Ramon, Balanzo-Joué, Marina, Morros, Rosa, Salvador-Gonzalez, Betlem
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 06.01.2022; BioMed Central; BMC
• Subjects: Acetates; Asthma; Chronic obstructive pulmonary disease; Clinical trials; Coronaviruses; COVID-19; COVID-19 - complications; Cyclopropanes; Cytokines; Dosage and administration; Double-Blind Method; Double-blind studies; Dyspnea; Evaluation; Health aspects; Hospitals; Humans; Immune system; Infections; Inflammation; Long COVID; Medical research; Montelukast; Mortality; Olfaction disorders; Oxygen Saturation; Patient admissions; Quality of Life; Quinolines; Randomized controlled trial; Randomized Controlled Trials as Topic; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Study Protocol; Sulfides; Taste disorders; Testing; Treatment Outcome; Viral infections; Spain; COVID-19; SARS-CoV-2; Dyspnea; Health status; Montelukast; Long COVID; Primary care; Randomized controlled trial; Quality of life
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05951-w

The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 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. To evaluate the efficacy of 10 mg oral montelukast every 24 h 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. 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 the 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 the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min 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; and (g) side effects of montelukast. 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 NCT04695704 . Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.