Ensayos clínicos

Inclusion Criteria:

• Participants must be ≥ 18 years of age at the time of signing the informed consent.
• Confirmed positive by PCR or antigen test for SARS-CoV-2 with sample collection ≤ 10 days prior to the day of randomization. PCR is the preferred method; however other tests for SARS-CoV-2 are allowed if authorized for use in the country.
• Covid-19 illness of any duration of symptoms.
• Participant capable of understanding the study and giving informed consent. Participant capable of signing and dating the written ICF. Participant must 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 ≤ 5 days 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; and
  • Meets the criteria for:
  • Category 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); OR
  • Category 5 - Hospitalized, requiring supplemental oxygen; OR
  • Category 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices per 8-point ordinal scale.
• 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 Cockcroft-Gault formula or 24-hour urine ≥ 30 mL/min;
  • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 × 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.