A Phase 3 interventional study of Cromolyn Sodium and Placebo in COVID-19 Pneumonia, COVID-19 Respiratory Infection and Pneumonia, Viral, sponsored by Texas Tech University Health Sciences Center, El Paso. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Texas Tech University Health Sciences Center, El Paso · Phase 3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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.
Also known as: Nasal Crom
Nebulized treatment for 4 days followed by intranasal treatment starting on day 5.
Also known as: Saline
Change in requirement for oxygen supplementation based on daily assessment of flow (LPM or %Fi O2) and delivery device (cannula, mask, CPAP/BiPAP, ventilator)
Determination of trend in subject's need for oxygen supplementation over time.
Time frame: up to 21 days
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.
Determination of trend in subject's respiratory symptoms over time.
Time frame: up to 21 days
hospital length of stay
number of days from admission to discharge
Time frame: up to 21 days
change the patient score from the PROMIS survey provided to subjects at days 7, 14, and 21.
Determination of number of days to improved quality of life (QOL) from start of study treatment
Time frame: up to 21 days
number of return visits to hospital
any readmission to hospital after discharge
Time frame: up to 21 days
assignment of COVID-19 outcomes
based on WHO classification
Time frame: up to 21 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center, El Paso