Clinical Trials

Inclusion Criteria:

• Participants must be ≥ 18 years of age at the time of signing the informed consent.
• Confirmed positive by PCR test for SARS-CoV-2 within 72 hours before randomization.
• Onset of symptoms not more than 7 days prior to randomization.
• Understand and agree to comply with planned study procedures for the duration of the study. The study visits beyond Day 28 will be optional and require a separate consent.
• Hospitalized for Covid-19 illness for ≤ 72 hours with mild to moderate Covid-19 symptoms including:
  • Mild: Symptoms of Covid-19 including fever, rhinorrhea, mild cough, sore throat, headache, muscle pain, malaise but not requiring supplemental oxygen;
  • Moderate: Lower respiratory symptoms: shortness of breath (SOB) or signs of pneumonia or lung infiltrates based on X-ray or computed tomography (CT) scan < 50% present;
  • Maintains O2 saturation of at least 93% on room air or supplemental O2 at randomization.
• Adequate organ function, as defined by:
  • CBC: ANC > 1000/mm^3 , platelets> 75,000mm^3 , Hgb> 9 gm/100 cc;
  • Calculated creatinine clearance based on ideal body weight per CockcroftGault formula or 24-hour urine ≥ 30 mL/min;
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN) - D-dimer < 10,000 ng/mL.
• Eligible participants of child-bearing age (male or female) must agree to use at least 1 medically accepted method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices), or agree to abstinence for 6 weeks. Female participants or the female partners of male participants who become pregnant during the study or within the protocol-specified period after their last CPI-006 administration should immediately inform their treating physicians.

Exclusion Criteria:

• Signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening (and randomization) or anticipated impending need for mechanical ventilation.
• History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
• Any uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit (ICU).
• Patients with malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of Screening.
• Receipt of cancer chemotherapy or immunomodulatory drugs including (but not limited to) biologics such as anti-CD20, anti-TNF, anti-IL6; alkylating agents (e.g., cyclophosphamide); antimetabolites (e.g., azathioprine); or chronic corticosteroid use equivalent to prednisone > 10 gm/day, during preceding 2 months.
  • Note: Steroids for treatment of Covid-19 is acceptable.
• Patients who are participating in other clinical trials including participants in an extended access program (EAP).
• Active deep vein thrombosis or pulmonary embolism as confirmed by the investigator within last 6 months.
• Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours of admission as confirmed by the investigator.
• Any active uncontrolled co-morbid disease that might interfere with study conduct or interpretation of findings.
• Known to be positive for HIV or positive test for chronic HBV infection (defined as positive hepatitis B surface antigen [HBsAg]) or positive test for hepatitis C antibody.
• Convalescent plasma (CCP) or anti-SARS-CoV-2 monoclonal antibodies administered less than 24 hours prior to randomization. Patient must have recovered from any adverse events related to CCP treatment. Received chloroquine or hydroxychloroquine within last 7 days or during the study.
• Pregnancy or breast feeding.