The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 520
- 主要终点
- Pulmonary inflammation resolution time (HRCT) (day)
研究概览
简要总结
The novel coronavirus infectious disease ( COVID-19") induced by novel coronavirus(SARS-CoV-2) in December 2019 has outbreaked in Wuhan. It may lead to epidemic risk in global. As the COVID-19 is an emerging infectious disease, it has not scientifically recognized and has no effective drugs for treatment currently. Therefore, we will launch a scientific project "The efficacy and safety of carrimycin treatment in 520 patients with COVID-19 stratificated clinically: A multicenter, randomized (1:1), open-controlled (one of lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate) study" . We try to establish the criteria for clinical cure and the early predictive model of COVID-19 progression. The primary efficiency outcomes were:(1) Fever to normal time (day); (2) Pulmonary inflammation resolution time (HRCT) (day); and (3)Negative conversion (%) of SARS-CoV-2 RNA at the end of treatment. The secondary efficiency outcomes and adverse events were observed.
详细描述
- Data management The electronic data collection system (EDC) will be used in this study for the collection and management of the study data to ensure the traceability of the clinical trial data; the data management process shall comply with the GCP specification to ensure the authenticity, integrity and accuracy of clinical trial data. The main data management processes are listed below. For other details, please refer to the data management plan (DMP).
DMP is written by the data manager (DM) as the guiding document for data management. The data management work will be carried out according to the time, content and method defined by DMP.
1.1Design and establishment of database The data manager designs and constructs the database according to the trial protocol, and sets up the logic verification according to the data validation plan (DVP), which i released for use after passing the test and being approved by the investigator.
1.2Data entry The investigator or a person authorized by the investigator shall timely complete the online data entry after the subject visit, use the printed eCRF form first if necessary, and, in case of data correction in eCRF if required, fill in the reason for the data modification according to the system prompt. The logic validation program of the EDC system will logically check the input data and question the problem data, so as to facilitate the modification or interpretation by the investigator or the person authorized by the investigator.
1.3Source data validation (SDV) The investigator logs on EDC on the study site, 100% check the consistency of eCRF data and source data, and ask questions at any time in case of any problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects or their legal representatives have signed the informed consent form(ICF); agree not to participate in other clinical studies within 30 days after the last administration from the first administration of the study drug.
- •Subjects are aged ≥ 18 and ≤ 75;
- •Meet the diagnostic criteria for 2019-nCoV pneumonia (V5.0);
- •SOFA score: 1 ~ 13 points.
- •A retreated patient or the relapsed patient meets any of the following criteria:
- •Have fever again or aggravated clinical symptoms; ② 2019nCOVRNA in the throat swabs converts from negative to positive; ③ The clinical symptoms don't improve or 2019nCOVRNA continues to be positive; ④ The chest CT shows pneumonia or fibrosis progression.
- •Clinical stratification:
- •Mild type: clinical symptoms mild or asymptomatic, no pneumonia performance in CT, but positive 2019-nCoV in throat swabs or gargle.
- •Ordinary type: fever, respiratory symptoms, etc., pneumonia performance visible in CT.
- •Severe type: meeting any of the following criteria:
- •(1) Respiratory distress, RR≥30 times/min; (2) Finger oxygen saturation ≤93% in rest state; (3) Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation (FiO2)≤300mmHg (1mmHg=0.133kPa).
- •Critical type: meeting any of the following criteria:(1)Respiratory failure occurs and mechanical ventilation is required;(2)Patients go into shock;(3)ICU is needed for other organ failure.
排除标准
- •Other viral pneumonia
- •Patients who have received tumor immunotherapy (such as PD-1/L1, CTLA4, etc.) in the past 1 month, and inflammatory factor modulators such as Ulinastatin;
- •Patients who have taken anti-bacterial drugs such as macrolide in the past 1 week;
- •Patients who have received organ transplantation or surgery planning in the past 6 months;
- •Patients who can't take food or drugs due to coma or intestinal obstruction;
- •Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc.
- •Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation), or subjects that may fail to take effective contraceptive measures within the next 6 months;
- •Patients with allergic constitution, or patients allergic to macrolides and lopinavir/ritonavir tablets;
- •Patients with contraindications to lopinavir/ritonavir tablets who plan or are using drugs that interact with the drug (including: drugs that are highly dependent on CYP3A clearance and whose elevated plasma concentrations can be associated with severe and/or life-threatening events [with a narrow therapeutic index], CYP3A inducer [see instruction for details]) and cannot stop using or use other drugs instead;
- •Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal, or patients with child-Pugh grade C cirrhosis.
- •ECLS (ECMO, ECCO2R, RRT)
- •Critical patients with expected life<48 hours
- •Patients who have participated in any other clinical study within 1 month;
- •The investigators conclude that the patients not suitable for the study.
研究组 & 干预措施
Carrimycin
basic treatment + Carrimycin
干预措施: basic treatment (Drug)
Carrimycin
basic treatment + Carrimycin
干预措施: Carrimycin (Drug)
lopinavir/ritonavir or Arbidol or chloroquine phosphate
any of basic treatment + lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate
干预措施: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate (Drug)
lopinavir/ritonavir or Arbidol or chloroquine phosphate
any of basic treatment + lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate
干预措施: basic treatment (Drug)
结局指标
主要结局
Pulmonary inflammation resolution time (HRCT) (day)
时间窗: 30 days
Pulmonary inflammation resolution time (HRCT) (day)
Fever to normal time (day)
时间窗: 30 days
Fever to normal time (day)
Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment
时间窗: 30 days
Negative conversion (%) of 2019-nCOVRNA in gargle (throat swabs) at the end of treatment
次要结局
未报告次要终点
研究者
Jin Ronghua
Director
Beijing YouAn Hospital