Cromolyn Sodium for COVID-19

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding cromolyn to standard COVID-19 treatment improves symptoms and speeds recovery for patients with COVID-19 pneumonia. Participants inhale cromolyn as a mist for four days, then use a nasal spray for two weeks. To qualify, participants must be hospitalized with COVID-19 pneumonia, require extra oxygen, and meet specific breathing and health criteria. Researchers will compare cromolyn's effects to a placebo (a look-alike treatment with no active drug). Monitoring occurs both in the hospital and after discharge for a total of 21 days. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cromolyn sodium is generally safe and well-tolerated. This medication has a long history of use and a strong safety record. Doctors commonly use it to treat allergies and asthma, so they are familiar with it.

Studies have found that cromolyn sodium can help reduce swelling, which is important because swelling can worsen COVID-19 symptoms. While side effects can occur, they are usually mild. Some people might experience irritation at the application site, but serious side effects are rare.

In summary, cromolyn sodium has been safely used for other conditions, suggesting it should be well-tolerated when combined with standard COVID-19 treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Unlike the standard treatments for COVID-19, which often include antivirals and monoclonal antibodies, Cromolyn Sodium offers a unique approach by stabilizing mast cells to prevent the release of inflammatory substances. This treatment is delivered via nebulizer and intranasal spray, allowing it to target the respiratory system directly. Researchers are excited about Cromolyn Sodium because it could potentially reduce inflammation quickly and efficiently, offering faster relief from symptoms compared to existing options.

What evidence suggests that cromolyn sodium might be an effective treatment for COVID-19?

Research has shown that cromolyn sodium, which participants in this trial may receive, might help treat COVID-19 by reducing inflammation and a severe immune reaction called a cytokine storm, experienced by some patients. It appears effective in lowering this type of inflammation, a major issue for those with severe COVID-19. Studies suggest that cromolyn sodium can calm the body's immune response, possibly improving symptoms and speeding recovery. Although more information is needed, these findings offer a hopeful outlook for its use in COVID-19 treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Edward A Michelson, MD

Principal Investigator

Texas Tech University Health Sciences Center, Department of Emergency Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05077917

Cromolyn Sodium for Treatment of COVID-19 Pneumonia Cromolyn will be administered as a nebulized treatment four times a day for four days followed by intranasal administration for two weeks.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05077917?term=CROMOLYN%20SODIUM&viewType=Table&rank=2

Cromolyn Sodium for Treatment of COVID-19 Pneumonia A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7832727/

Tackling the cytokine storm in COVID-19, challenges and hopes Several trials have already reported important results concerning the effectiveness and safety of CQ and HCQ in treating SARS-CoV-2. ... The therapeutic effects ...

4. mdpi.com mdpi.com/2073-4409/10/7/1761

Cytokine Storm Syndrome in SARS-CoV-2 Infections It should be taken into consideration that cromolyn sodium is currently deemed to be effective in decreasing inflammation and cytokine storms in patients with ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006295220305323

Repurposing existing drugs for the treatment of COVID-19 ... In this review we provide a comprehensive analysis of some cancer drugs and others that can be repurposed for the treatment of COVID-19.

6. bmj.com bmj.com/content/368/bmj.m1252/rr-1

Re: Covid-19: what treatments are being investigated? Cromolyn Sodium May Attenuate Covid-19 SARS and Systemic Complications and May Be Useful Prophylactically. Fatalities due to SARS-COV2 (COVID 19) ...

7. goodrx.com goodrx.com/nasalcrom/nasalcrom-faqs?srsltid=AfmBOooabPm1yfVWkbeb3-KzNC4AGXl2NijAJSTookm0x6b3RDhAgb7A

Is NasalCrom Considered a Steroid? 6 FAQs, Answered It has few side effects and long-standing safety data. But ... Generic cromolyn sodium's price at certain pharmacies may be as low ...