Cromolyn Sodium for Treatment of COVID-19 Pneumonia

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso
• Collaborator: Adli Karadsheh, MD, MS
• Treatments: Cromolyn Sodium

Criteria

Inclusion Criteria:

1. COVID-19 symptoms (fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress),

2. diagnosis of COVID-19 pneumonia with an admission chest x-ray demonstrating multilobar ground glass infiltrates consistent with COVID-19 pneumonia.

3. room air estimated PaO2/FiO2 ratio between 150 -280

4. must correct to a pulse oximetry of 90% or better using no more than 5 liters of low flow supplemental oxygen

5. must be enrolled within 24 hours of hospital admission

Exclusion Criteria:

1. 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

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

3. have DNR status or not expected to survive >7 days

4. experiencing shock (on vasopressors) or multiple organ dysfunction or failure

5. are co-infected with influenza A or B

6. history of DVT or PE within last 12 weeks

7. currently pregnant or nursing

8. participating in another therapeutic trial

9. allergic to cromolyn sodium.