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Mast Cell Stabilizer

Cromolyn Sodium for Viral Pneumonia

Phase 3
Recruiting
Led By Edward A Michelson, MD
Research Sponsored by Texas Tech University Health Sciences Center, El Paso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of COVID-19 pneumonia with an admission chest x-ray demonstrating multilobar ground glass infiltrates consistent with COVID-19 pneumonia
Must correct to a pulse oximetry of 90% or better using no more than 5 liters of low flow supplemental oxygen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days
Awards & highlights

Study Summary

This trial will test whether adding cromolyn to the standard treatment of hospitalized patients with COVID-19 pneumonia improves patient symptoms and reduces the number of days to improved quality of life.

Who is the study for?
This trial is for hospitalized COVID-19 pneumonia patients who need some oxygen but not too much. They must have certain symptoms like fever and cough, and a chest x-ray showing signs of COVID-19 pneumonia. People with weak immune systems, other serious infections or conditions, pregnant or nursing women, those on high oxygen support or in critical condition can't join.Check my eligibility
What is being tested?
The study tests if Cromolyn Sodium helps improve symptoms when added to standard COVID-19 care. Patients will get either Cromolyn Sodium or a placebo as an inhaled treatment for four days then through the nose for two weeks. The goal is to see if they feel better faster.See study design
What are the potential side effects?
Cromolyn Sodium might cause side effects such as coughing, wheezing, throat irritation or dryness after inhalation; however specific side effects related to this trial are not listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have COVID-19 pneumonia, confirmed by a chest x-ray showing specific signs.
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My oxygen levels can reach 90% or higher with minimal extra oxygen.
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I am experiencing symptoms like fever, cough, or difficulty breathing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in requirement for oxygen supplementation based on daily assessment of flow (LPM or %Fi O2) and delivery device (cannula, mask, CPAP/BiPAP, ventilator)
Change in respiratory symptoms (cough, shortness of breath, and fatigue) determined by data extraction from medical record, self-assessment by subject, or subject survey as appropriate for stage of the study.
Secondary outcome measures
change the patient score from the PROMIS survey provided to subjects at days 7, 14, and 21.
hospital length of stay
Other outcome measures
assignment of COVID-19 outcomes
number of return visits to hospital

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CromolynExperimental Treatment1 Intervention
2mL of 1% cromolyn sodium solution delivered via nebulizer 4 times a day for 4 days followed by 4% cromolyn solution administered intranasally 4 times per day for 14 days
Group II: PlaceboPlacebo Group1 Intervention
2-3mL of normal saline delivered via nebulizer 4 times a day for 4 days followed by intranasal administration of normal saline 4 times per day for 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cromolyn Sodium
2013
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Texas Tech University Health Sciences Center, El PasoLead Sponsor
49 Previous Clinical Trials
5,060 Total Patients Enrolled
Edward A Michelson, MDPrincipal InvestigatorTexas Tech University Health Sciences Center, Department of Emergency Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What health conditions has Cromolyn Sodium been shown to improve?

"Cromolyn Sodium is most commonly used to ameliorate the effects of vernal keratoconjunctivitis but can also help those suffering from conditions like conjunctivitis, food allergies, and exercise-induced bronchospasm."

Answered by AI

Would this program be appropriate for elderly patients?

"In order to take part in this research, patients must be between 18-80 years old. Out of the 1430 total clinical trials, 205 are for minors and 1125 are for senior citizens."

Answered by AI

Are they looking for more participants in this test?

"The study, which was posted on November 15th 2021 and last edited on May 9th 2022, is actively recruiting patients according to clinicaltrials.gov."

Answered by AI

How many people with the condition are being asked to participate in this test?

"That is correct, the study is still recruiting patients according to the latest information available on clinicaltrials.gov. 60 people are needed in total, and so far only 1 out of the proposed sites has been fully enrolled."

Answered by AI

How do I sign up for this chance to test a new medication?

"This study is for patients who have pneumonia, viral and are between 18-80 years old. They hope to admit 60 people in total."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cromolyn Sodium for Treatment of COVID-19 Pneumonia
Edward Michelson, MD 2021. "Cromolyn Sodium for Treatment of COVID-19 Pneumonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05077917.
~2 spots leftby Jun 2024
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