What side effects are associated with this type of intervention?

Cromolyn, a mast cell stabilizer, is generally well-tolerated with side effects primarily including mild naso-pharyngeal irritation. In the context of viral pneumonia, treatments often involve supportive care and antiviral medications, which can have side effects such as gastrointestinal disturbances, headache, and fatigue. When combined with standard treatments, cromolyn may help improve symptoms with minimal additional side effects.

What prior FDA approvals exist?

FDA-approved treatments for viral pneumonia primarily include antiviral medications such as remdesivir, which is used to treat COVID-19 pneumonia. While cromolyn, a mast cell stabilizer, is being studied for its potential benefits in treating COVID-19 pneumonia, it is not yet FDA-approved for this indication. Mast cell stabilizers like cromolyn are generally used for allergic conditions and asthma, rather than viral infections. Therefore, the focus remains on antiviral agents and supportive care for managing viral pneumonia.

What other types of research exist?

Promising novel alternatives to Cromolyn for viral pneumonia patients include: 1) Hemoperfusion with polymyxin-B immobilized fiber, which has shown improved oxygenation and survival rates in patients with acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). 2) Inhaled corticosteroids like budesonide, which have demonstrated efficacy in reducing symptoms and complications in COVID-19 patients. 3) Antiviral treatments such as molnupiravir and nirmatrelvir plus ritonavir, which have been effective in reducing mortality and hospitalization rates in COVID-19 patients.

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Mast Cell Stabilizer

Cromolyn Sodium for COVID-19

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

Must not have

Immunocompromised due to current use of immunosuppressive drugs or chemotherapy, have a history of HIV/organ transplant/ active hepatitis B or C, or are on hemodialysis or peritoneal dialysis

Currently on oxygen supplementation greater than low flow nasal cannula (including home oxygen therapy; CPAP for obstructive sleep apnea is not an exclusion)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 21 days

Awards & highlights

Pivotal Trial

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I use more than just a low flow nasal cannula for oxygen.

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I am experiencing shock or multiple organ failure.

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I am currently infected with either influenza A or B.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

change the patient score from the PROMIS survey provided to subjects at days 7, 14, and 21.

hospital length of stay

Other study objectives

assignment of COVID-19 outcomes

number of return visits to hospital

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for viral pneumonia include antiviral agents, supportive care, and in some cases, adjunctive therapies like mast cell stabilizers. Antiviral agents, such as remdesivir, work by inhibiting viral replication, thereby reducing the viral load and helping the immune system to control the infection. Supportive care, including oxygen therapy and hydration, helps manage symptoms and maintain vital functions while the body fights the virus. Cromolyn, a mast cell stabilizer, works by preventing the release of inflammatory mediators from mast cells, which can reduce inflammation and improve respiratory function. Understanding these mechanisms is crucial for viral pneumonia patients as it helps them comprehend how these treatments can alleviate symptoms, reduce disease severity, and improve recovery outcomes.