A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of UI030 in COVID-19 Patients

Korea United Pharm., NCT05055414, NCT05055414, Nov 2022

Budesonide for COVID-19

20th treatment shown to reduce risk in April 2021, now with p = 0.0000011 from 15 studies, recognized in 10 countries.

Lower risk for mortality, ICU, hospitalization, progression, recovery, and cases.

No treatment is 100% effective. Protocols combine treatments.

6,200+ studies for 200+ treatments. c19early.org

Download Meta Analysis

Estimated 140 patient budesonide early treatment RCT with results not reported over 3 years after estimated completion.

4 budesonide RCTs have results missing long after expected1-4
The trials report a total of 916 patients, with 1 trial having actual enrollment of 146, and the remainder estimated.

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1. Marcy et al., Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection: A Multi-Arm Multi-Stage Randomized Trial (MAMS) to Evaluate the Effectiveness of Several Specific Treatments in Reducing the Risk of Clinical Worsening or Death in Sub-Saharan Africa (COVERAGE-Africa), NCT04920838, clinicaltrials.gov/study/NCT04920838clinicaltrials.gov.

2. Korea United Pharm., A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2 Study to Evaluate the Efficacy and Safety of UI030 in COVID-19 Patients, NCT05055414, clinicaltrials.gov/study/NCT05055414clinicaltrials.gov.

3. Taille et al., Protective Role of Inhaled Steroids for Covid-19 Infection, NCT04331054, clinicaltrials.gov/study/NCT04331054clinicaltrials.gov.

4. Afazeli et al., Evaluation of Efficacy of Pharmacotherapy Treatment of COVID-19 Infection Using Oral Levamisole and Formoterol+Budesonide Inhaler and Comparison of This Treatment Protocol With Standard National Treatment of the Disease, NCT04331470, clinicaltrials.gov/study/NCT04331470clinicaltrials.gov.

Korea United Pharm. et al., 1 Nov 2022, Double Blind Randomized Controlled Trial, placebo-controlled, South Korea, trial NCT05055414 (history).