PER-081-20招募中未知
A PRAGMATIC ADAPTIVE RANDOMIZED CONTROLLED PHASE II/III MULTICENTER STUDY OF IFX-1 IN PATIENTS WITH SEVERE COVID-19 PNEUMONIA --- PANAMO”
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 14
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
- •Patients must meet all the following criteria at randomization to be enrolled into Phase III of the
- •1. At least 18 years of age or older
- •2. Patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of randomization)
- •3. Patients with a PaO2 / FiO2 ratio of < 200 and > 60 at randomization (one representative measurement within 6h before randomization)
- •4. SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)
排除标准
- •Patients who fulfill any of the following criteria at randomization are not eligible to participate in
- •Phase III of the study:
- •1. Intubated > 48h at time point of randomization
- •2. Expected stop of invasive ventilation or expected extubation in the next 24h without additional intervention according to judgment of the investigator
- •3. Known history of chronic dialysis OR received renal replacement therapy in past 14 days OR anticipated to receive renal replacement therapy within 24h after randomization
- •4. Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months
- •5. Treatment of COVID-19 with investigational antibody treatment(s) which are not approved or not included in locally adopted treatment guidelines (e.g., WHO guidance, National Institutes of Health [NIH] COVID-19 treatment guidelines) for this indication in the past 7 days (Note: Antibody treatment[s] given within past 7 days for pre-existing diseases, other than COVID-19, are allowed.)
- •6. At time point of randomization, treatment of COVID-19 with investigational treatments which are not approved or not included in locally adopted treatment guidelines for this indication (e.g., WHO guidance, NIH COVID-19 treatment guidelines), including SARS-CoV-2 multiplication inhibitor(s) or immunomodulator(s). (Note: If a locally adopted treatment guideline recommends drugs such as remdesivir, dexamethasone, or anticoagulation, this would be allowed. Adopted guidelines and updates must be
- •documented at study initiation and throughout the conduct of the study.)
- •7. Known hypersensitivity to IFX-1 or any other ingredient of the study medication
- •8. Serum or urine pregnancy test positive before randomization (required for women of childbearing potential)
- •9. Received organ or bone marrow transplantation in past 3 months
- •10. Known cardio-pulmonary mechanical resuscitation in past 14 days
- •11. Received cytokine adsorption therapy in past 3 days
- •12. Patient moribund or expected to die in next 24h according to the judgment of the investigator
- •13. Known to have received anti-cancer therapy for hemato-oncological disease in past 4 weeks
- •OR known to have active malignant disease at time point of randomization
- •14. Known severe congestive heart failure (NYHA Class III-IV; see Appendix 8)
- •15. Known history of chronic liver disease (Child-Pugh B or C; see Appendix 9)
- •16. Participating in or has participated in other investigational interventional studies (drug or device) within the last 7 days before randomization
研究者
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