NL-OMON55215已完成3 期
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
- 3 期
- 状态
- 已完成
- 发起方
- InflaRx GmbH
- 入组人数
- 125
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients must meet all the following criteria at randomization to be enrolled
- •into Phase III of the study:
- •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 first IMP administration)
- •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 first IMP administration
- •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.,
- •World Health Organization [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. Received cytokine adsorption therapy in past 3 days
- •8. Known hypersensitivity to IFX-1 or any other ingredient of the study
- •9. Serum or urine pregnancy test positive before randomization (required for
- •women of childbearing potential)
- •10. Received organ or bone marrow transplantation in past 3 months
- •11. Known cardio-pulmonary mechanical resuscitation in past 14 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 (corresponding to e.g. New York Heart
- •Association [NYHA] Class III IV, left ventricular ejection fraction <40%)
- •15. Known history of chronic liver disease (Child-Pugh B or C)
- •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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