Cromolyn Sodium for Treatment of COVID-19 Pneumonia

Sponsor

Texas Tech University Health Sciences Center, El Paso (Other)

Overall Status

Recruiting

CT.gov ID

NCT05077917

Collaborator

(none)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pneumonia COVID-19 Respiratory Infection Pneumonia, Viral	Drug: Cromolyn Sodium Other: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind, placebo-controlled, randomized trialDouble blind, placebo-controlled, randomized trial

Masking:

Double (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Cromolyn Sodium for Treatment of COVID-19 Pneumonia

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Cromolyn Sodium Nebulized treatment for 4 days followed by intranasal treatment starting on day 5. Other Names: Nasal Crom
Placebo Comparator: 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	Other: Placebo Nebulized treatment for 4 days followed by intranasal treatment starting on day 5. Other Names: Saline

Arm

Intervention/Treatment

Experimental: 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

Drug: Cromolyn Sodium

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

Other Names:

Nasal Crom

Placebo Comparator: 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

Other: Placebo

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

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

Change in requirement for oxygen supplementation based on daily assessment of flow (LPM or %Fi O2) and delivery device (cannula, mask, CPAP/BiPAP, ventilator) [up to 21 days]
Determination of trend in subject's need for oxygen supplementation over time.
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. [up to 21 days]
Determination of trend in subject's respiratory symptoms over time.

Secondary Outcome Measures

hospital length of stay [up to 21 days]
number of days from admission to discharge
change the patient score from the PROMIS survey provided to subjects at days 7, 14, and 21. [up to 21 days]
Determination of number of days to improved quality of life (QOL) from start of study treatment

Other Outcome Measures

number of return visits to hospital [up to 21 days]
any readmission to hospital after discharge
assignment of COVID-19 outcomes [up to 21 days]
based on WHO classification

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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)
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.