Cromolyn Sodium for Treatment of COVID-19 Pneumonia

NCT05077917 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: E21197
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19 Pneumonia; COVID-19 Respiratory Infection; Pneumonia, Viral

Keywords

COVID-19 pneumonia; Cromolyn sodium; Cromolyn

Outcome Measures

Primary Outcomes (2)

• Change in requirement for oxygen supplementation based on daily assessment of flow (LPM or %Fi O2) and delivery device (cannula, mask, CPAP/BiPAP, ventilator)

  Determination of trend in subject's need for oxygen supplementation over time.

  up to 21 days

• 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.

  Determination of trend in subject's respiratory symptoms over time.

  up to 21 days

Secondary Outcomes (2)

• hospital length of stay

  up to 21 days

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

  up to 21 days

Other Outcomes (2)

• number of return visits to hospital

  up to 21 days

• assignment of COVID-19 outcomes

  up to 21 days

Study Arms (2)

Cromolyn

EXPERIMENTAL

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

Drug: Cromolyn Sodium

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Cromolyn Sodium DRUG

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

Also known as: Nasal Crom

Cromolyn

Placebo OTHER

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

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19 symptoms (fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress),
• diagnosis of COVID-19 pneumonia with an admission chest x-ray demonstrating multilobar ground glass infiltrates consistent with COVID-19 pneumonia.
• room air estimated PaO2/FiO2 ratio between 150 -280
• must correct to a pulse oximetry of 90% or better using no more than 5 liters of low flow supplemental oxygen
• must be enrolled within 24 hours of hospital admission

You may not qualify if:

• 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
• have DNR status or not expected to survive \>7 days
• experiencing shock (on vasopressors) or multiple organ dysfunction or failure
• are co-infected with influenza A or B
• history of DVT or PE within last 12 weeks
• currently pregnant or nursing
• participating in another therapeutic trial
• allergic to cromolyn sodium.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

University Medical Center of El Paso

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Pneumonia, Viral

Interventions

Cromolyn Sodium; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Edward A Michelson, MD

  Texas Tech University Health Sciences Center, Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant, investigator, and the study team will be blinded to assignment of study drug or placebo. Only pharmacy and data committee will have key to drug assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Dept of Emergency Medicine

Model Details: Double blind, placebo-controlled, randomized trial

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 14, 2021
• Study Start: November 15, 2021
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)