A trial of EC-18 in patients with mild/moderate pneumonia due to COVID-19
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Lincoln Medical Center
The Bronx, New York, United States
RECRUITINGKent County Memorial Hospital
Warwick, Rhode Island, United States
RECRUITINGProportion of patients alive and free of respiratory failure through at Day 28
Time frame: 28 days
Probability of progression of mild pneumonia patients to severe pneumonia or ARDS within 28 days
Time frame: 28 days
Assessment of all-cause mortality
Time frame: 28 days
Respiratory failure defined based on resource utilization requiring at least 1 of the following:
* Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20L/min with a fraction of delivered oxygen ≥ 0.5) * Non-invasive positive pressure ventilation * Extracorporeal membrane oxygenation
Time frame: 28 days
Proportion of patients alive and free of invasive mechanical ventilation at a pre-specified timepoint
Time frame: 28 days
Proportion of patients alive and discharged from the hospital at a pre-specified timepoint
Time frame: 28 days
Lengths of ICU stay
Time frame: 28 days
Lengths of alive and respiratory failure-free days
Time frame: 28 days
Proportion of patients with objective measures of improvement (returning to room air) at time points (days 7, 14, and 28)
Time frame: 7, 14, and 28 days
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Confirmation of changes in subject's subjective clinical symptoms (e.g., patient questionnaire)
o Check for changes in symptoms on a daily basis for 28 days compared to the baseline at day 1
Time frame: 28 days