EUCTR2020-005532-29-IT进行中（未招募）1 期
Randomized, placebo-controlled, double-blind, multicenter, seamless adaptive phase II-III clinical trial to select the dose and evaluate safety and efficacy of MAD0004J08 monoclonal antibody in adult patients with recently diagnosed asymptomatic to moderately severe COVID-19. -
Toscana Life Sciences Sviluppo0 个研究点目标入组 806 人开始时间: 2021年4月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 806
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed written informed consent taken before any study procedure from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative.
- •2. Age = 18 years.
- •3. First nasopharyngeal swab testing positive for SARS-CoV-2 by RT-PCR taken no more than 3 days before randomization (Visit 1). Results of rapid” semiquantitative tests are not acceptable.
- •4. Asymptomatic to moderately symptomatic outpatients with no need for immediate hospitalization: grade 1, or grade 2 or grade 3 of Clinical Severity Scale.
- •5. No childbearing potential (post-menopause, surgically-induced, or pharmacologicallyinduced sterility) or, if of childbearing potential, negative urinary pregnancy test (women) and commitment to use at least 2 forms of contraception for at least 168 days from administration of study drug (men and women).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 206
排除标准
- •1. Severe or critical COVID-19: grade 4 or grade 5 of clinical severity scale.
- •2. Current hospitalization and/or hospitalization or emergency room visit in the past 14 days.
- •3. Need for immediate hospitalization for any reason in the investigator’s opinion.
- •4. Severe liver disease as determined by values of ALT and/or AST >5x upper limit of normal (ULN) and/or history of liver cirrhosis.
- •5. Severe renal disease as determined by estimated creatinine clearance (CcCl) <30 mL/min or serum creatinine >2 mg/dL (>176.8 µmol/L) or ongoing renal dialysis.
- •6. Absolute neutrophil count (ANC) < 1000/µL.
- •7. Demyelinating and connective tissue disease.
- •8. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
- •9. Any condition that in the Investigator’s opinion may be negatively affected by the study treatments and/or study procedures.
- •10. Any condition, including psychiatric disorders, alcohol, or substance abuse, which in the Investigator’s opinion may interfere with completion of the study procedures.
- •11. Any condition with life expectancy <6 months in the Investigator’s opinion.
- •12. Ongoing or planned pregnancy.
- •13. Ongoing breast feeding.
- •14. History of life-threatening event in the 1 month before Visit 1.
- •15. History of surgery in the 1 month before Visit 1.
- •16. History of treatment with blood components in the 6 months before Visit 1.
- •17. History of cancer treated with chemotherapy in the 6 months before Visit 1.
- •18. History of solid organ transplant at any time before Visit 1.
- •19. History of severe and/or serious allergic reaction to monoclonal antibodies or any component of MAD0004J08, including anaphylaxis at any time before Visit 1.
- •20. Treatment with an investigational drug or vaccine within 5 half-lives or 30 days (whichever is longer) of randomization.
- •21. Treatment at any time with monoclonal antibodies bamlanivimab, bamlanivimab + etesevimab combination, and casiribimab + imdevimab combination .
- •Receipt of an approved vaccine vs. COVID-19 is NOT an exclusion criterion, i.e. is compatible with enrolment in the study if all inclusion and exclusion criteria are met.
研究者
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