To evaluate the safety and efficacy of antroquinonol treatment of mild to moderate pneumonia due to COVID-19, as measured by the proportion of patients alive and free of respiratory failure.
This is a randomized, double blind, placebo controlled, Phase 2, proof of concept study in hospitalized patients with mild to moderate pneumonia due to COVID 19. Written informed consent must be obtained from all patients during screening. Following completion of all screening assessments and meeting of eligibility criteria, patients will either receive antroquinonol or placebo for 14 days in combination with SoC therapy per local SoC policies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
double-blind for antroquinonol and Placebo with same out-look and same frequency.
Capsule without active compound
Franciscan Health Michigan City
Michigan City, Indiana, United States
Ascension.Via Christi Research
Wichita, Kansas, United States
Recover Ratio
Number of Patients Who are Alive and Free of Respiratory Failure (e.g., no need for invasive mechanical ventilation, non invasive ventilation, high flow oxygen, or ECMO) on Day 14.
Time frame: 14 day
Time to 2-point Improvement, Score 2 or Lower, and Score 0 From Baseline on the WHO COVID-19 Clinical Improvement Ordinal Scale
Time to 2-point improvement from baseline, time to score 2 and lower from baseline and time to score 0 from baseline are measured by WHO COVID-19 Clinical Improvement Ordinal Scale
Time frame: 28-day
Duration of Hospitalization
Duration of hospitalization is the total number of days the patient is hospitalized during their participation in the study, up to Day 28.
Time frame: 28 day
Time to Virological Clearance
measured as study days from start of treatment to first negative SARS CoV 2 PCR test
Time frame: 28 day
Number of Patients Who Recovered From Loss of Taste or Smell
Patients with loss of taste or smell from baseline and back to normal during the observation period.
Time frame: 28 days
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Adventist Healthcare Shady Grove Medical Center
Rockville, Maryland, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Duke University Southeastern Health
Lumberton, North Carolina, United States
Centro Gallego
Buenos Aires, Buenos Aires F.D., Argentina
Clinica de los Virreyes
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Privado Mayo SA
Córdoba, Ciudad de Cordoba, Argentina
Hospital Rawson
Córdoba, Cuidad de Cordoba, Argentina
Clinica Viedma SA
Viedma, Pcia de Rio Negro, Argentina
...and 5 more locations