This is a phase 3, randomized, placebo controlled, double-blind, multicenter, stratified study of CPI-006 plus standard of care (SOC) versus placebo plus SOC in mild to moderately symptomatic hospitalized Covid-19 patients with the primary objective to compare the proportion of participants alive and respiratory failure free between CPI-006 plus SOC versus placebo plus SOC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
IV CPI-006 2 mg/kg up to a maximum dose of 200 mg plus standard of care
IV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care
IV placebo plus standard of care
Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC
Proportion of participants who are alive and free from respiratory deterioration in each active arm compared to placebo arm as measured by the modified World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.
Time frame: During the 28 days after dosing
Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
Time to recovery after dosing in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death.
Time frame: During the 28 days after dosing
Time to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
Time to clinical improvement in each active arm compared to placebo arm as measured by the modified WHO 8-point Ordinal Scale for Clinical Improvement in which: 1=Not hospitalized, no limitations on activities; 2=Not hospitalized, limitation on activities and/or requiring home oxygen; 3=Hospitalized, not requiring supplemental oxygen - no longer requiring ongoing medical care; 4=Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 5=Hospitalized, requiring supplemental oxygen; 6=Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7=Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 8=Death. Clinical improvement is defined as ≥ 2 points improvement in the 8-point ordinal scale.
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Sharp Chula Vista Medical Center
Chula Vista, California, United States
El Centro Regional Medical Center
El Centro, California, United States
Sharp Grossmont Hospital
La Mesa, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Cambridge Medical Trials
Alexandria, Louisiana, United States
MedPharmics
Metairie, Louisiana, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
...and 81 more locations
Time frame: During the 28 days after dosing
Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
Proportion of participants who died in each active arm compared to placebo arm
Time frame: During the 28 days after dosing