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

Trials

Ramon Monf๠ Ana García-Sangenís¹  Rosa Morros²  Sara Bonet-Monne³  Marina Balanzo-Joué³  Gemma Alvarez-Muñoz⁴  Jesús Almeda-Ortega⁵  Sara Contreras-Martos⁵  Betlem Salvador-Gonzalez⁶  Francisco Mera-Cordero⁷  Oriol Cunillera-Puèrtolas⁸ 

[1] Institut Universitari de Recerca en Atenció Primària Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain;Clinical Trials Research Unit (UICEC) IDIAPJGol – Platform SCReN, Barcelona, Spain;Institut Universitari de Recerca en Atenció Primària Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain;Clinical Trials Research Unit (UICEC) IDIAPJGol – Platform SCReN, Barcelona, Spain;Department of Pharmacology and Therapeutics, Universitat Autònoma de Barcelona, Bellaterra, Spain;Institut Universitari de Recerca en Atenció Primària Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain;Pharmacy Unit SAP Baix Llobregat Centre, Primary Care Management Costa Ponent, Catalan Institute of Health, Cornellà de Llobregat, Spain;Institut Universitari de Recerca en Atenció Primària Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain;Primary Care Covid Notification and Monitoring Unit UNSC Metropolitana SUD, Primary Care Management Costa de Ponent, Catalan Institute of Health, L’Hospitalet de Llobregat, Spain;Institut Universitari de Recerca en Atenció Primària Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain;Primary Care Research Support Unit (USR) Costa de Ponent, Primary Care Management Costa de Ponent, Catalan Institute of Health, Cornellà de Llobregat, Spain;Institut Universitari de Recerca en Atenció Primària Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain;Primary Care Research Support Unit (USR) Costa de Ponent, Primary Care Management Costa de Ponent, Catalan Institute of Health, Cornellà de Llobregat, Spain;Clinical Trials Research Unit (UICEC) IDIAPJGol – Platform SCReN, Barcelona, Spain;Primary Care EAP El Pla Sant Feliu de Llobregat, Primary Care Management Costa de Ponent, Catalan Institute of Health, L’Hospitalet de Llobregat, Spain;Institut Universitari de Recerca en Atenció Primària Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain;Primary Care Research Support Unit (USR) Costa Ponent, Institut Universitari de Recerca en Atenció Primària Jordi Gol i Gurina (IDIAPJGol), Cornellà de Llobregat, Spain;

关键词: Montelukast;    Dyspnea;    Randomized controlled trial;    COVID-19;    SARS-CoV-2;    Long COVID;    Primary care;    Quality of life;    Health status;   

DOI  :  10.1186/s13063-021-05951-w

来源: Springer

【 摘 要 】

BackgroundThe 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.ObjectivesTo 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.Methods and analysisPhase 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.Ethics and disseminationThis 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.Trial registrationClinicalTrials.govNCT04695704. Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.

【 授权许可】

CC BY