The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and moderate symptoms of COVID-19 disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Yale University
New Haven, Connecticut, United States
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Washington University in St. Louis
St Louis, Missouri, United States
Number of participants with treatment-related adverse events
Time frame: 30 days
WHO Ordinal Scale
Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.
Time frame: 30 days
Degree of supplemental oxygen
Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)
Time frame: 30 days
Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation measured by pulse oximetry
Time frame: 30 days
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Duke University
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
University of Texas Southwestern
Dallas, Texas, United States