ABX464 in Treating Inflammation and Preventing Acute Respiratory Failure in Patients With COVID-19

Inclusion Criteria

• •1. Adult (≥ 18 years old) men or women, hospitalized or not hospitalized, diagnosed for SARS-CoV-2 infection by PCR, with at least one associated risk factor. Considered risk factors are:
• •* Age ≥ 65 years
• •* Obesity defined as BMI ≥ 30
• •* Recent history of uncontrolled High Blood Pressure (SBP \> 150 mm Hg DBP \>100 mm Hg) according to investigator
• •* Treated diabetes (type I or II)
• •* History of ischemic cardiovascular disease
• •2. Symptomatic patients at enrollment. Symptoms are defined as fever (body temperature ≥ 37.8 C oral/tympanic, or ≥ 38.2 C rectal) for more than 24 hours associated either with headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no associated respiratory distress), myalgia, anosmia or ageusia.
• •3. Patients with pulse oximetry arterial saturation ≥ 92 % on room air at enrolment.
• •4. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to Day 0:
• •* Hemoglobin above 9.0 g / dL
• •* Absolute Neutrophil Count ≥ 1000 / mm3
• •* Platelets ≥ 100 000 mm3;
• •* Creatinine clearance ≥ 50 mL / min by the Cockcroft Gault formula
• •* Total serum bilirubin \< 2 x ULN
• •* Alkaline phosphatase \< 2 x ULN, AST (SGOT) and ALT (SGPT) \< 3 x ULN;