JPRN-jRCTs041200025已完成2 期
Japanese, multicenter, phase II trial of combination therapy with favipiravir and corticosteroids for coronavirus disease 2019 (COVID-19) patients with mild respiratory failure - J-CRITICAL trial
Yuichiro Shindo0 个研究点目标入组 69 人开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
研究概览
简要总结
Sixty-nine patients were enrolled and received study treatment. The proportion of patients who needed mechanical ven was 29.2% (90% confidence interval (CI): 20.1-39.9, p=0.200). The proportion of patients who needed MV or death within 30 days was 26.2%. Thirty-day mortality was 4.9%. The significant risk factor for MVCTI-14 was smoking history (odds ratio: 4.1, 95% CI: 1.2-14.2). The most common grade 3-4 treatment-related adverse event was hyperglycemia that was observed in 21.7%.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients who developed pneumonia* and need inpatient treatment (*pneumonia is defined as the presence of a new infiltrate on a chest radiograph or a computed tomography scan in addition to at least one of the following: new or increased cough or sputum production, new pleuritic chest pain, new or increased dyspnea, fever (temperature >= 37.5 degrees) or hypothermia (temperature <35.0 degrees), leukocytosis [white blood cell count (WBC) >=10,000/mm3] or leukopenia (WBC <4,000/mm3), elevated level of CRP value (exceed the upper threshold of each study institution), or new hypoxemia or deterioration of hypoxemia)
- •2. Positive PCR or antigen testing of SARS-CoV-2
- •3. Within 12 days of onset of symptoms
- •4. Patients with hypoxemia who need oxygen therapy (who meet one of the following: SpO2 =< 93% on room air; arterial oxygen partial pressure (PaO2) =< 60 mmHg or PaO2/ fraction of inspired oxygen (FiO2) < 300; or AaDO2 >= 40)
- •5. Age >= 20 years old
- •6. Informed consent must be obtained prior to participation in this study
- •7. Patients who were registered in observational registry studies organized by National Center for Global Health and Medicine or Fujita Health University (This criterion will not be applicable after the approval of favipiravir)
排除标准
- •1. Patients who meet the criteria of tracheal intubation (at least one of the following: 5 L/min or more of oxygen flux; unstable circulatory dynamics; or consciousness disturbance)
- •2. Intubated or tracheostomy was performed at time of initiation of treatment
- •3. Patients who need vasopressor(s) at time of initiation of treatment
- •4. Patients who are receiving systemic corticosteroids or immunosuppressive agents including biological ones at time of initiation of treatment
- •5. Patients with HIV or immunodeficiency disorders
- •6. Respiratory failure due to cardiac pulmonary edema
- •7. Apparent asthma attack
- •8. Apparent pulmonary embolism
- •9. Chronic pulmonary diseases (e.g., interstitial pneumonia and severe COPD) which potentially affect assessment of the efficacy of study treatment
- •10. Long term oxygen therapy
- •11. Malignant diseases which potentially affect assessment of the efficacy of study treatment
- •12. Complicating pneumonia due to apparent bacterial infection or aspiration
- •13. Patients who are receiving anti-SARS-CoV-2 agents (e.g., favipiravir, lopinavir/ritonavir, remdesivir, ciclesonide, etc.)
- •14. Patients who need to receive medications that affect the effect of corticosteroids (e.g., rifampicin, phenobarbital, phenytoin, and ephedrine)
- •15. Contraindication for use of favipiravir or corticosteroids (e.g., allergy to them)
- •16. Pregnant women and women suspected of being pregnant
- •17. Women who are not able to give informed consent regarding protected sexual intercourse from the initiation of favipiravir to 90 days after the end of its administration
- •18. Men or their partners who are not able to give informed consent regarding protected sexual intercourse from the initiation of favipiravir to 90 days after the end of its administration
- •19. Patients who may have difficulty receiving efficacy assessment due to dementia or mental disorders
- •20. Patients who are participating in other clinical studies which do not allow use of corticosteroids or those who are expected to participate in them
- •21. Patients in whom physicians in charge judged inappropriate for registration
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