CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
Condition: Covid-19
MeSH terms: COVID-19
Intervention: CPI-006 2 mg/kg + SOC; CPI-006 1 mg/kg + SOC; Placebo + SOC
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; Covid; Coronavirus; Covid19; COVID-19

Summary:

      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.
    

Eligibility criteria:

        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