E-speranza-COVID19 Project

This study aims to demonstrate efficacy of Montelukast for patients with persistent COVID-19 to help them improve their quality of life

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Key Words: COVID-19; SARS-CoV-2; Montelukast; Clinical Trial; Primary Care; Dyspnea; Long-COVID

What is persistent COVID-19?

In patients with mild-moderate symptoms of COVID-19, these last around 2 weeks, on average, from the beginning of symptomatology until recovery. This time goes up to 3-6 weeks when the infection is severe or critical. The average duration of mild and moderate cases, according to a European study, is established at 11.5 ± 5.7 days (1).

However, several studies have been reporting cases in which some of the symptoms of COVID-19 can last for more than 4 weeks, which is now known as persistent COVID-19. Nonetheless, since this is a new clinical entity, little information has been published about it in scientific journals, and the number of people that may be affected by it is unknown.

Why is this study important?

The symptoms which people with persistent COVID-19 endure may include dyspnea at minimum effort, cough, headache, arthralgias, low-grade fever, abdominal pain, asthenia, and skin symptoms. As such, this disease can be very disabling.

Nowadays, no information has been published in scientific journals about the possible efficacy of different treatments on persistent COVID-19.

The E-speranza COVID Project to demonstrate efficacy of Montelukast for patients with persistent COVID-19 to help them improve their quality of life.

Description of the Study:

  • Title: Double-blind randomized clinical trial, placebo-controlled to assess the efficacy of Montelukast in mild-moderate respiratory symptoms in patients with long-COVID.
  • Principal Investigator: Francisco Mera Cordero.
  • Co-Investigators: Sara Bonet Monne, Betlem Salvador González, Rosa Morros Pedrós, Jesús Almeda Ortega, Marina Balanzó Joué, Oriol Cunillera Puértolas.
  • Centers of Implementation: Primary Care centres of the “Direcció d’Atenció Primària (DAP) Costa de Ponent” of the “Institut Català de Salut” (Catalan Institute of Health).
  • Study Population: Adult individuals (> 18 years old) with infection by SARS-CoV-2, mild-moderate respiratory symptoms, and more than one month of evolution. Of the 284 patients recruited, half will be assigned to the experimental group, and the other half to the control group.
  • Study type: Double-blind, Randomized, Phase III Clinical Trial.
  • Design: randomization of participants will be done by an independent statistician, in a proportion of 1:1. The distribution will be done by blocks, stratifying by sex and initial severity of dyspnea as determined by the mMRC scale (categories 0-1 and 1-2), to ensure proportionality of groups by these factors.
  • Methods: the primary outcome will be the quality of life of respiratory symptomatology according to CAT. Twelve more secondary outcomes will be measured.

Objectives of the Study:

Principal Objective: to evaluate the efficacy of low-dose Montelukast versus placebo to reduce respiratory symptoms of patients with infection by SARS-CoV-2 with mild-moderate, persistent, respiratory clinic.

More about this Study:

Justification: Montelukast, the drug used in this Clinical Trial, is a leukotrienes receptor antagonist. By acting over receptor CysLT1 at the lungs, it blocks the bronchoconstriction action of some leukotrienes, thus reducing inflammation. The hypothesis of using Montelukast in this study is based on the physiological response to COVID-19, mediated by the immune system after infection of SARS-CoV-2.

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