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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 18, 2021

Interventions

  • Drug: CPI-006 2 mg/kg + SOC
    • IV CPI-006 2 mg/kg up to a maximum dose of 200 mg plus standard of care
  • Drug: CPI-006 1 mg/kg + SOC
    • IV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care
  • Drug: Placebo + SOC
    • IV placebo plus standard of care

Arms, Groups and Cohorts

  • Experimental: CPI-006 (2 mg/kg) Plus Standard of Care
    • 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.
  • Experimental: CPI-006 (1 mg/kg) Plus Standard of Care
    • 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.
  • Placebo Comparator: Placebo Plus Standard of Care
    • Participants will receive a single dose of placebo intravenously on Day 1 plus standard of care.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of Participants Alive and Respiratory Failure Free of CPI-006 Plus SOC Versus Placebo Plus SOC
    • Time Frame: During the 28 days after dosing
    • 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.

Secondary Measures

  • Time to Recovery of CPI-006 Plus SOC Versus Placebo Plus SOC
    • Time Frame: During the 28 days after dosing
    • 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 to Clinical Improvement of CPI-006 Plus SOC Versus Placebo Plus SOC
    • Time Frame: During the 28 days after dosing
    • 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.
  • Mortality Rate Due to Any Cause of CPI-006 Plus SOC Versus Placebo Plus SOC
    • Time Frame: During the 28 days after dosing
    • Proportion of participants who died in each active arm compared to placebo arm

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Corvus Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • S. Mahabhashyam, MD, MPH, Study Chair, Corvus Pharmaceuticals

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