Cromolyn Sodium for Treatment of COVID-19 Pneumonia

NCT ID: NCT05077917

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2024-05-23

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.

Detailed Description

The study will take place in two phases: Phase 1 will be an open label study of 10 patients who will all receive the Cromolyn nebulization treatment followed by Cromolyn nasal spray to assess tolerability and response to the study treatment. Investigators may also draw blood from 10 healthy patients who will be the controls for the cellular and cytokine assays. Phase 2 will be a randomized double blind placebo-controlled study of 50 patients randomized 1:1 to receive Cromolyn nebulization followed by Cromolyn intranasal spray vs. saline nebulization and saline intranasal spray.

While subjects are hospitalized, investigators will record morning pulse, respiratory rate and oxygen saturation. Morning and daily peak oxygen supplementation as indicated by the use of high flow nasal cannula, non-invasive ventilation, or invasive ventilation will be recorded. The investigators will also note any improvement or decline in participant's condition and any reduction or increase in oxygen supplementation.

Follow-up phone calls (or EMR review if still hospitalized) will be made on days 7, 14, and 21 to assess dyspnea and physical function. Validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) (https://www.healthmeasures.net/explore-measurement-systems/promis) will be used to evaluate dyspnea and physical function. Once discharged, patients will also be asked to maintain a daily log of nasal drug use, COVID-19 symptoms, resting pulse and oxygen saturation which will be reviewed at the 21 day virtual visit.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cromolyn

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 Type: EXPERIMENTAL

Cromolyn Sodium

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Cromolyn Sodium

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Nasal Crom; Saline

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role: lead

Responsible Party

Edward Michelson, MD

Professor and Chair, Dept of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward A Michelson, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center, Department of Emergency Medicine

Locations

University Medical Center of El Paso

El Paso, Texas, United States

Countries

United States

Other Identifiers

E21197

Identifier Type: -

Identifier Source: org_study_id