Cromolyn Sodium for COVID-19

Recruiting at 1 trial location

Overseen By Leann Rodriguez

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Texas Tech University Health Sciences Center, El Paso

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Immunocompromised, Influenza, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 3 weeks

22 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if adding cromolyn to standard COVID-19 treatment helps hospitalized patients with severe symptoms. Cromolyn is given through a nebulizer and nasal spray to reduce lung inflammation, aiming to improve breathing and overall quality of life.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is cromolyn sodium safe for humans?

Cromolyn sodium has been shown to be generally safe in humans, with mild and reversible side effects like dermatitis (skin irritation), myositis (muscle inflammation), and gastroenteritis (stomach inflammation) in a small percentage of asthma patients. In studies for asthma and eye conditions, side effects were usually mild and did not require stopping the medication. ^{1 2 3 4 5}

How does the drug Cromolyn Sodium differ from other COVID-19 treatments?

Cromolyn Sodium is unique because it is traditionally used to prevent allergic reactions by stabilizing mast cells (cells involved in allergic responses), and its use for COVID-19 is novel as it may help reduce inflammation in the lungs, which is a key issue in severe COVID-19 cases. Unlike other COVID-19 treatments, Cromolyn Sodium's mechanism focuses on preventing the release of substances that cause inflammation, potentially offering a different approach to managing the disease. ^{6 7 8 9 10}

Research Team

Edward A Michelson, MD

Principal Investigator

Texas Tech University Health Sciences Center, Department of Emergency Medicine

Eligibility Criteria

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.

Inclusion Criteria

I have COVID-19 pneumonia, confirmed by a chest x-ray showing specific signs.

My oxygen levels can reach 90% or higher with minimal extra oxygen.

I was enrolled in the trial within a day of being admitted to the hospital.

Exclusion Criteria

I have had a blood clot in my leg or lung in the past 3 months.

Have DNR status or not expected to survive >7 days

I am immunocompromised due to medication, HIV, organ transplant, hepatitis B/C, or dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive cromolyn sodium or placebo via nebulization for 4 days followed by intranasal administration for 14 days

3 weeks

Daily visits while hospitalized, virtual visits on days 7, 14, and 21

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up phone calls or EMR review on days 7, 14, and 21

3 weeks

3 virtual visits

Treatment Details

Interventions

• Cromolyn Sodium
• Placebo

Trial Overview 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.

Participant Groups

Group I: Cromolyn Experimental Treatment 1 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: Placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center, El Paso

Lead Sponsor

Trials

51

Recruited

5,800+

References

1. United States pubmed.ncbi.nlm.nih.gov

Adverse reactions to cromolyn. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Cromolyn sodium in the treatment of children with severe, perennial asthma. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Cromolyn sodium in the treatment of asthma: its effectiveness and use. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of topical cromolyn sodium in the treatment of vernal keratoconjunctivitis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Failure of cromolyn sodium to reduce the incidence of bronchopulmonary dysplasia: a pilot study. The Neonatal Cromolyn Study Group. [2013]

6. India pubmed.ncbi.nlm.nih.gov

The inhibitory effect of cromolyn sodium and ketotifen on Toxoplasma gondii entrance into host cells in vitro and in vivo. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Diclofenac (Voltarol) in rheumatoid arthritis: a report of a double-blind trial. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Double-blind trial of dapsone against placebo in the treatment of rheumatoid arthritis. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of nabumetone in the treatment of active adult rheumatoid arthritis. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of five analgesics for the pain of rheumatoid synovitis. [2020]