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Cromolyn Sodium for Treatment of COVID-19 Pneumonia

NCT05077917 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-11-18

No results posted yet for this study

Summary

The study hypothesis is that cromolyn, when combined with standard COVID-19 treatment, will improve patient symptoms and reduce the number of days to improved quality of life.

Investigators will study the effects of adding cromolyn to the standard treatment of hospitalized patients with COVID-19 pneumonia and who require supplemental oxygen. Cromolyn will be administered as a nebulized treatment four times a day for four days followed by intranasal administration for two weeks. Investigators may also screen for biomarkers that could indicate inflammatory responses and treatment-induced improvement.

Participants will receive either study drug or placebo which will be administered by nebulization for 4 days followed by 14 days of intranasal administration. Participants will be followed while in the hospital and then as outpatients up to day 21 following randomization.

Conditions

Interventions

DRUG

Cromolyn Sodium

Nebulized treatment for 4 days followed by intranasal treatment starting on day 5.

OTHER

Placebo

Nebulized treatment for 4 days followed by intranasal treatment starting on day 5.

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center, El Paso

    lead OTHER

Principal Investigators

  • Edward A Michelson, MD · Texas Tech University Health Sciences Center, Department of Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2024-05-23
Completion
2024-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077917 on ClinicalTrials.gov