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Trial - NCT05077917


Column Value
Trial registration number NCT05077917
Full text link
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05077917

First author
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Susan Watts, PhD

Contact
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Susan.Watts@ttuhsc.edu

Registration date
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

2021-10-14

Recruitment status
Last imported at : March 12, 2022, midnight
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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.

Number of arms
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Texas Tech University Health Sciences Center, El Paso

Inclusion age min
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Change in requirement for oxygen supplementation based on daily assessment of flow (LPM or %Fi O2) and delivery device (cannula, mask, CPAP/BiPAP, ventilator);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.

Notes
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2000, "treatment_name": "Cromolyn", "treatment_type": "Nasal spray", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]