Cromolyn Sodium for Treatment of COVID-19 Pneumonia

STUDY OVERVIEW

This study by TTUHSC El Paso aims to investigate the efficacy of adding cromolyn to standard treatment for COVID-19 pneumonia in hospitalized patients requiring supplemental oxygen, hypothesizing that cromolyn will improve symptoms and shorten time to improved quality of life. The study consists of two phases: an initial open-label tolerability assessment followed by a randomized, double-blind, placebo-controlled trial, assessing clinical outcomes, biomarkers of inflammation, and patient-reported outcomes up to 21 days post-randomization.

STUDY GOALS

To assess the therapeutic potential of cromolyn, administered via nebulization and intranasal spray, as an adjunct to standard treatment for COVID-19 pneumonia in hospitalized patients requiring supplemental oxygen, aiming to improve symptoms and accelerate the achievement of improved quality of life.

LOCATION

El Paso, Texas: Texas Tech Health Sciences Center at El Paso

INCLUSION CRITERIA

  • Cognitive function assessed with a modified Telephone Interview for Cognitive Status (TICS-M) indicating intact cognition.

  • Phosphorylated tau (P-tau) result consistent with amyloid and early-tau pathology.

  • Reliable study partner familiar with overall function and behavior.

  • Adequate literacy, vision, and hearing for neuropsychological testing.

  • Contraceptive use consistent with local regulations.

  • Female participants meeting infertility criteria or post-menopausal status.

EXCLUSION CRITERIA

  • Mild cognitive impairment, dementia, or other significant neurodegenerative diseases.

  • Serious or unstable illnesses with life expectancy ≤5 years.

  • History of cancer with high recurrence risk.

  • Severe drug allergies or hypersensitivity reactions.

  • Clinically significant abnormalities on MRI or lab tests.

  • Contraindications for MRI.

  • Imaging abnormalities indicating potential risk.

  • Recent treatment with anti-amyloid therapy.

  • Previous active immunization against amyloid beta.

  • Current or past use of medications for mild cognitive impairment or Alzheimer's disease.

For more information, visit ClinicalTrials.gov.