Clinical trial NCT05077917: Cromolyn Sodium for Treatment of COVID-19 Pneumonia
Official title: Cromolyn Sodium for Treatment of COVID-19 Pneumonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19 Pneumonia
COVID-19 Respiratory Infection
Pneumonia, Viral
Keywords: COVID-19 pneumonia
Cromolyn sodium
Cromolyn
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, placebo-controlled, randomized trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in requirement for oxygen supplementation based on daily assessment of flow (LPM or %Fi O2) and delivery device (cannula, mask, CPAP/BiPAP, ventilator)
timeFrame: up to 21 days
measure: 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.
timeFrame: up to 21 days
Secondary outcomes:
measure: hospital length of stay
timeFrame: up to 21 days
measure: change the patient score from the PROMIS survey provided to subjects at days 7, 14, and 21.
timeFrame: up to 21 days
Other outcomes:
measure: number of return visits to hospital
timeFrame: up to 21 days
measure: assignment of COVID-19 outcomes
timeFrame: up to 21 days
Locations:
city: EL Paso
country: United States
facility: University Medical Center of El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center, Department of Emergency Medicine
name: Edward A Michelson, MD
role: PRINCIPAL_INVESTIGATOR
References: