A National, Multi-Center, Open-Label, Three-Arm, Phase II Study to Investigate the Effect of Montelukast Between Emergency Room Visits and Hospitalizations in COVID-19 Pneumonia in Comparison With Standard Treatment

Durdagi et al., NCT04718285, NCT04718285, Jun 2022

Montelukast for COVID-19

32nd treatment shown to reduce risk in November 2021, now with p = 0.0041 from 9 studies.

Lower risk for hospitalization and cases.

No treatment is 100% effective.
Protocols combine treatments.

c19early.org

Meta-analysis

Estimated 380 patient montelukast early treatment RCT with results not reported over 4 years after estimated completion.

2 montelukast RCTs have results missing long after expected1,2
The trials report an estimated total of 664 patients.

Important missing comments or errors? Let us know.

1. Cordero et al., Double-blind Randomized Clinical Trial, Placebo-controlled to Assess the Efficacy of Montelukast in Mild-moderate Respiratory Symptoms in Patients With Long-COVID-19: E-SPERANZA COVID-19 PROJECT, NCT04695704, clinicaltrials.gov/study/NCT04695704clinicaltrials.gov.

2. Durdagi et al., A National, Multi-Center, Open-Label, Three-Arm, Phase II Study to Investigate the Effect of Montelukast Between Emergency Room Visits and Hospitalizations in COVID-19 Pneumonia in Comparison With Standard Treatment, NCT04718285, clinicaltrials.gov/study/NCT04718285clinicaltrials.gov.

Durdagi et al., 1 Jun 2022, Randomized Controlled Trial, Turkey, trial NCT04718285 (history). Contact: serdar.durdagi@med.bau.edu.tr.

Outcome (studies)

Improvement

Relative risk · 95% CI

All studies (9)39%

Mortality (2)64%

ICU admission (2)0%

Hospitalization (7)15%

Progression (4)33%

Recovery (4)23%

Cases (1)82%

RCTs (5)39%

Prophylaxis (2)64%

Late (7)40%

after exclusions

00.511.5+

← Montelukast
reduces riskIncreased
risk →

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