Sponsor decision. Not related to safety issues.

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.

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

Investigators are free to publish/present study results from their site upon occurrence of one of either: a multi-center publication, no publication is submitted within 18 months after end of study, or sponsor confirms there will be no publication. Investigators must provide the sponsor all draft publications for review at least 30 days prior to submission. Sponsor may request to defer publication and/or delete sponsor's confidential information to allow the sponsor to preserve its IP rights.