CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients

Conditions
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Covid-19

Intervention / Treatment
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* Drug: CPI-006 2 mg/kg + SOC
* Drug: CPI-006 1 mg/kg + SOC
* Drug: Placebo + SOC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed positive by polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 with sample collection ≤ 10 days prior to randomization Covid-19 illness of any duration of symptoms Hospitalized for Covid-19 for ≤ 5 days with mild to moderate Covid-19 symptoms and meets criteria for either Category 4, Category 5, or Category 6 per 8-point ordinal scale Adequate organ function Participants of child-bearing age must agree to use adequate contraception for 6 weeks after study treatment administration Exclusion Criteria: Signs of acute respiratory distress syndrome or respiratory failure necessitating mechanical ventilation at time of screening/randomization or anticipated need for mechanical ventilation History of severe chronic respiratory disease and requirement for long-term oxygen therapy Uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit Malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of screening Receipt of cancer chemotherapy or immunomodulatory drugs during preceding 2 months (steroids for treatment of Covid-19 are acceptable) Convalescent plasma (CCP) or anti-SARS-CoV-2 monoclonal antibodies administered <24 hours prior to randomization. Must have recovered from any adverse events related to CCP treatment. Received chloroquine or hydroxychloroquine within last 7 days or during the study Current participation in other clinical trials including extended access programs Active deep vein thrombosis or pulmonary embolism within last 6 months Anticipated discharge from hospital or transfer to another hospital which is not a study site within 48 hours of admission Active uncontrolled co-morbid disease that may interfere with study conduct or interpretation of findings Known to be positive for HIV or positive test for chronic HBV infection or positive test for hepatitis C antibody Pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPI-006 (2 mg/kg) Plus Standard of Care<br>Participants will receive a single dose of CPI-006 at 2 mg/kg up to a maximum dose of 200 mg intravenously on Day 1 plus standard of care. | Drug: CPI-006 2 mg/kg + SOC<br>* IV CPI-006 2 mg/kg up to a maximum dose of 200 mg plus standard of care<br>|
| Experimental: CPI-006 (1 mg/kg) Plus Standard of Care<br>Participants will receive a single dose of CPI-006 at 1 mg/kg up to a maximum dose of 100 mg intravenously on Day 1 plus standard of care. | Drug: CPI-006 1 mg/kg + SOC<br>* IV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care<br>|
| Placebo Comparator: Placebo Plus Standard of Care<br>Participants will receive a single dose of placebo intravenously on Day 1 plus standard of care. | Drug: Placebo + SOC<br>* IV placebo plus standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During the 28 days after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | During the 28 days after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, Covid, Coronavirus, Covid19, COVID-19