PER-069-20尚未招募未知
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).
ABIVAX S.A.,0 个研究点目标入组 32 人开始时间: 2020年10月5日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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).
排除标准
- •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.
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