COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04695704

Francisco M Mera Cordero, MD

franmcor@hotmail.com

2021-01-05

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: patients 18 to 80 years old with sars-cov-2 infection (positive crp <10 days from the onset of symptoms) treated in primary health care. persistent respiratory symptoms (more than 1 and <12 months of evolution) mild-moderate dyspnea: score at the beginning of the study according to the modified medical research council (mmrc) scale from 0 to 3 the patient must be competent to complement the follow-up evaluations. the patient agrees to participate in the study and take assigned medication during the 4 weeks. sign the informed consent

- severity criteria: fever> 38ºc, or o2 saturation <93%. - patients with sars-cov-2 pneumonia in the acute / subacute phase. - patients who have required hospital admission for sars-cov-2. - chronic obstructive pulmonary disease (copd), asthma, bronchiectasis, pulmonary fibrosis, obstructive sleep apnea syndrome (osas), chronic respiratory failure from any cause, home oxygen therapy. - use of montelukast or zafirlukast ≤ 30 days prior to inclusion - use of any dose of systemic corticosteroids ≤ 30 days prior to inclusion - use of gemfibrocil. - hypersensitivity to montelukast or to any of the excipients included (e.g. lactose. - any condition (including the inability to swallow pills) that, in the opinion of the researcher, would prevent the completion of taking the medication. - active malignancy, current or recent chemotherapy treatment (<6 months). - medical history of infection by the human immunodeficiency virus (hiv) or any serious immunocompromised state. - pregnancy, planning to get pregnant or patients of childbearing age not undergoing birth control methods. - breastfeeding mother. - any other condition for which, in the opinion of the principal investigator, it is considered that the subject does not fit the study.

2

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

18

80

Spain

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

284

COP Assessment Test Scale (CAT)

None

Phase 3

[{"arm_notes": "", "treatment_id": 816, "treatment_name": "Montelukast", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]