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;

Exclusion Criteria:

1. Patients with moderate or severe acute respiratory failure or requiring noninvasive
ventilation or oxygen or with SpO2 < 92% or tachypnea (respiratory rate ≥ 30
breaths/min).

2. Patients treated with immunosuppressors and/or immunomodulators.

3. Engrafted patients (organ and/or hematopoietic stem cells).

4. Patients with uncontrolled auto-immune disease.

5. Patients with known or suspected active (i.e. not controlled) bacterial, viral
(excluding COVID-19) or fungal infections.

6. Patients with preexisting, severe and not controlled organ failure.

7. History or active malignancy requiring chemotherapy or radiation therapy (excluding 2
years disease free survivor patients).

8. Pregnant or breast-feeding women.

9. Illicit drug or alcohol abuse or dependence that may compromise the patient's safety
or adherence to the study protocol.

10. Use of any investigational or non-registered product within 3 months or within 5
half-lives preceding baseline, whichever is longer.

11. Hypersensitivity to ABX464 and/or its excipients.

12. Any condition, which in the opinion of the investigator, could compromise the
patient's safety or adherence to the study protocol.