A PHASE 2/3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND THE SAFETY OF ABX464 IN TREATING INFLAMMATION AND PREVENTING COVID-19 ASSOCIATED ACUTE RESPIRATORY FAILURE IN PATIENTS AGED ≥ 65 AND PATIENTS AGED ≥18 WITH AT LEAST ONE ADDITIONAL RISK FACTOR WHO ARE INFECTED WITH SARS-COV-2. (THE MIR-AGE STUDY).
- Conditions
- -J22 Unspecified acute lower respiratory infectionUnspecified acute lower respiratory infectionJ22
- Registration Number
- PER-069-20
- Lead Sponsor
- ABIVAX S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 32
1. Adult (≥ 18 years old) men or women, hospitalized or not hospitalized, diagnosed for SARS-CoV-2 infection by PCR (within 48 hours prior to randomization), 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
• Treated diabetes (type I or II)
• History of ischemic cardiovascular disease
2. Symptomatic patients must present at least 1 of the following symptoms at enrollment: fever or perceived fever
for more than 24 hours, headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no
associated respiratory distress), myalgia, anosmia, ageusia, or gastro-intestinal symptoms.
3. Patients with pulse oximetry arterial saturation (SpO2) ≥ 92 % on room air at enrolment.
4. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior
to D0:
• Hemoglobin > 9.0 g dL-1
• Absolute Neutrophil Count ≥ 1000 mm-3;
• Platelets ≥ 100,000 mm-3;
• Creatinine clearance ≥ 50 mL min-1 by the Cockcroft-Gault formula
• Total serum bilirubin < 2 x ULN
• Alkaline phosphatase< 2 x ULN, AST (SGOT) and ALT (SGPT) < 3 x ULN;
5. Women of childbearing potential and men receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to enrolment. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test.
6. Patients must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures.
7. Patients able and willing to comply with study visits and procedures as per protocol.
8. Patients should be affiliated to a social security regimen (for French sites only).
Patients who meet any of the following exclusion criteria will be excluded from the study:
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 (cf. Appendix #2).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Rate of patients who do not require use of high-flow oxygen (use of high-flow oxygen being defined as settings of 3 L/min or greater AND with at least one SpO2 measurement < 92%, with or without O2 supplementation) or, invasive or non-invasive mechanical ventilation (IMV and NIV, respectively) within 28 days and who are alive at the end of the 28 days period.<br>Measure:Rate of patients who do not require use of high-flow oxygen (use of high-flow oxygen being defined as settings of 3 L/min or greater AND with at least one SpO2 measurement < 92%, with or without O2 supplementation) or, invasive or non-invasive mechanical ventilation (IMV and NIV, respectively) within 28 days and who are alive at the end of the 28 days period.<br>Timepoints:Day 28<br>
- Secondary Outcome Measures
Name Time Method