Cromolyn Sodium for Treatment of COVID-19 Pneumonia

Phase

Condition

Pneumonia

Respiratory Syncytial Virus (Rsv) Infection

Corona Virus

Treatment

Cromolyn Sodium

Placebo

Clinical Study ID

NCT05077917

E21197

Ages 18-80
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 demonstratingmultilobar 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 lowflow supplemental oxygen
must be enrolled within 24 hours of hospital admission

Exclusion

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 onhemodialysis or peritoneal dialysis
currently on oxygen supplementation greater than low flow nasal cannula (includinghome 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.

Study Design

Cromolyn Sodium

November 15, 2021

May 23, 2024

Study 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.

Connect with a study center

University Medical Center of El Paso
EL Paso, Texas 79905
United States
Site Not Available

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