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
Among 33 studies in Pneumonia, Viral with a site in United States — 5 open to participants now, 6 under way, 3 of them phase 3. Pneumonia, Viral · United States.
Among the 33 studies in Pneumonia, Viral with a site in United States, this one is the 18th largest by enrollment of the 27 interventional ones that give a count, is one of 10 that started in 2021, is one of 8 in phase 3, and was the 23rd registered.
156 studies on the registry are indexed under Pneumonia, Viral; 13 are open to participants now.
Browse Pneumonia, Viral studies →5 of the 33 studies in Pneumonia, Viral with a site in United States are open now. Recruiting first, the newest first:
BioNTech SE · Sites in United States
Ages 5+ · Healthy volunteers
BioNTech SE · Sites in United States
Ages 18–64 · Healthy volunteers
Pfizer · Sites in United States, Argentina, Belgium and 15 more countries
Ages 18+
All Natural Medicine Clinic, LLC · Sites in United States
Pfizer · Sites in United States, Argentina, Belgium and 16 more countries
Ages 12+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Pneumonia, Viral studies recruiting now, 8 set no upper age limit and 1 stops at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 9 · Phase 3 8 · Phase 4 3
First in 2008; this study’s year is marked. 10 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 76 across 88 interventional studies indexed under Pneumonia, Viral.
Median enrollment 50 across the 27 interventional studies, 250 across the 5 observational. Of the 18 that completed or were terminated, 9 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 33 have an industry lead sponsor. The 10 most frequent:
Texas Tech University Health Sciences Center, El Paso is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Texas Tech University Health Sciences Center, El Paso has 1 study filed under Pneumonia, Viral — fewer than ten, so there is no comparison to draw.
5 of the studies in Pneumonia, Viral with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07798648Phase 3BioNTech SEA Study of COVID-19 Vaccine(s) in Children and Adults | 2027-04-21 |
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT04790240All Natural Medicine Clinic, LLCMedical Herbs Inhibit Inflammation Directing T Cells to Kill the COVID-19 Virus (COVID) | 2026-12-30 |
| NCT07730450BioNTech SEA Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of Age | 2027-08-20 |
Among the 33 studies in Pneumonia, Viral with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Ran from Nov 2021 to primary completion in May 2024, 30 months.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Cromolyn
Texas Tech University Health Sciences Center, El Paso