COVID-19 and Anti-CD14 Treatment Trial (CaTT)

Inclusion Criteria:

Patients included in the study must meet all the following criteria:

• Patient or legally authorized representative able to provide informed consent
• Presence of SARS-CoV-2 infection documented by positive RT-PCR testing or history of positive RT-PCR test for SARS-CoV-2 within 7 days of screening
• Radiologic findings compatible with diagnosis of SARS-CoV-2 pulmonary infection

• Hypoxemia as defined by any of the following:

  • SpO2 ≤94% on room air, or
  • Requirement for ≥2L/m O2 per standard nasal cannula to maintain SpO2≥94%, but not requiring high-flow nasal cannula (defined as ≥30 L/m), and
• Negative pregnancy test for women of childbearing potential and, must be willing to use birth control for the duration of the study.

Exclusion Criteria:

An individual fulfilling any of the following criteria should be excluded from enrollment in the study:

• Receiving non-invasive positive-pressure ventilation through nasal mask, face mask, or nasal plugs
• Receiving invasive mechanical ventilation

• Patient, surrogate, or physician not committed to full support

  --Exception: a participant will not be excluded if he/she would receive all supportive care other than attempts at resuscitation from cardiac arrest)

• Anticipated survival <48 hours
• Underlying malignancy, or other condition, with estimated life expectancy of less than two months

• Significant pre-existing organ dysfunction prior to randomization

  • Lung: Currently receiving home oxygen therapy as documented in medical record
  • Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record
  • Renal: End-stage renal disease requiring renal replacement therapy or eGFR <30 mL/min
  • Liver: Severe chronic liver disease defined as Child-Pugh Class C or AST or ALT >5x upper limit of normal
  • Hematologic: Baseline platelet count <50,000/mm^3

• Presence of co-existing infection, including, but not limited to:

  • HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell/mm^3
  • Active tuberculosis or a history of inadequately treated tuberculosis
  • Active hepatitis B or hepatitis C viral infection

• Ongoing immunosuppression

  • Solid organ transplant recipient
  • High-dose corticosteroids (equivalent to >20 mg/prednisone/day) within the past 28 days, except for dexamethasone except for dexamethasone or equivalent treatment for COVID-19 illness
  • Oncolytic drug therapy within the past 14 days
• Current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actemra®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments
• Current treatment with an anti-viral medication for COVID-19 (e.g. hydroxychloroquine, lopinavir/ritonavir), other than remdesivir
• Current enrollment in an interventional trial for COVID-19
• History of hypersensitivity or idiosyncratic reaction to IC14
• Women who are currently breastfeeding
• Received a live-attenuated vaccine within 30 days prior to enrollment
• Received five or more doses of remdesivir, including the loading dose, outside of the study as treatment for COVID-19, or
• Any condition that in the opinion of the treating physician will increase the risk for the participant.