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 1:1 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.
ABSTRACT
Objective: We explore the association between montelukast use and the risk of developing COVID-19 complications in people with confirmed or suspected COVID- 19. Material and/or methods: Study based on electronic health records from the SIDIAP database, which includes 5,835,000 people in Catalonia (80% of total population). In a cohort of people with confirmed or suspected COVID-19 (diagnosis registry, positive PCR and/or a serologic test or non-confirmed diagnosis or test along with a record of hospitalization, pneumonia and/or death related to COVID-19), we identified people on montelukast treatment (an active prescription or a prescription ending 90 days before the index date) (confirmed or suspected Covid register) from March to June 2020 (exposed group). The non-exposed to montelukast cohort was built by pairing cases in a 1:4 ratio based on gender and age at the time of infection. We obtained socioeconomic risk factors and active comorbidities in the two previous years, and concomitant drugs. The COVID-19-related severe events analysed were hospitalization, pneumonia, death or any of the previous outcomes. For each outcome, we fitted a conditional logistic regression model to estimate the odds ratio with its 95% confidence interval (OR;CI95%) associated with montelukast use. The study was approved by the Clinical Research Ethics Committee IDIAPJGol. Results: During the study period, there were 183 (6.67%) hospitalizations in the exposed group and 554 (6.09%) in the non-exposed group, 40 (1.46%) and 176 (1.93%) pneumonias, 85 (3.1%) and 429 (4.72%) deaths and 258 (9.40%) and 996 (10.95%) of any of the outcomes, respectively. The corresponding multivariable ORs were 0.92 (CI95% 0.70-1.21) for hospitalization, 0.67 (0.44-1.00) for pneumonia, 0.79 (0.60-1.031) for death and 0.79 (0.63-0.99) for any of the outcomes. Conclusions: The results suggest that montelukast use could decrease the risk of complications in people with COVID-19.