COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49146

Lanjuan Li /Xiaowei Xu/Charile Xiang

ljli@zju.edu.cn

2020-02-07

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Diagnosed as novel coronavirus pneumonia (NCP) Patient: 1) Basis of diagnostic criteria: Notice on Printing and Distributing Pneumonia Diagnosis and Treatment Plan for New Coronavirus Infection (Trial Implementation Fourth Edition) (National Health Office Medical Letter C2020377) 2019-nCoV diagnosis of pneumonia: (1) Epidemiological history: A. Travel history or residence history in Wuhan area or other areas with continuous local case transmission within 14 days before onset, B. Contact history within 14 days before onset Patients with fever or respiratory symptoms from Wuhan City or other areas where local case transmission is ongoing, C. Aggregative onset or epidemiological association with new coronavirus infection. (2) Clinical manifestations: A. fever, B. imaging characteristics of pneumonia: multiple small patchy shadows and interstitial changes in the early stage, which are obvious in the extrapulmonary zone, and then develop into multiple ground glass infiltrates and infiltrates, which are severe Patients may have pulmonary consolidation, and pleural effusion is rare, C. The total number of white blood cells is normal or reduced in the early stage of onset, or the lymphocyte count is reduced. (3) Any one of the epidemiological history meets any two of the clinical manifestations as suspected cases, and those who have one of the following pathogenic evidence are confirmed cases: A. A new type of real-time fluorescence RT-PCR test for respiratory specimens or blood specimen Coronavirus-positive nucleic acid, B. Sequencing of viral genes in respiratory specimens or blood specimens, highly homologous to known new coronaviruses. (4) It is severe if it meets any of the following: A. Respiratory distress, RR > 30 beats / min, B. In resting state, means oxygen saturation < 93%, C. Arterial partial pressure of oxygen (PaO2) / oxygen Concentration (FiO2) <= 300mmHg (lmmHg = 0.133kPa). (5) It is critical if it meets any of the following: 1) respiratory failure occurs and requires mechanical ventilation, 2) shock occurs, 3) combined organ failure requires ICU monitoring and treatment 2. The patient or legal donor agrees to participate in the study and signs an informed consent form.

1. Pregnant or lactating women, 2. There are comorbidities that affect the judgment of the efficacy, such as those with malignant tumors or long-term immunosuppressants, 3. The investigator believes that the patient has other conditions that are not suitable for enrollment, 4. Allergic to dimethyl sulfoxide (DMSO), dextran 40 or human albumin, 5. Contraindicated signs of artificial liver therapy

5

The First Affiliated Hospital; College of Medicine; Zhejiang University

1

99

China

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

63

Mortality in patients;

| Declared number of arm (5.0) differs from found arms (6.0)

Phase 0

[{"arm_notes": "Two control groups", "treatment_id": 599, "treatment_name": "Human menstrual blood-derived stem cells preparations", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 1529, "treatment_name": "Artificial liver therapy+human menstrual blood-derived stem cells preparations", "treatment_type": "Life support+advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Non pharmacological treatment+biological treatment"}, {"arm_notes": "", "treatment_id": 123, "treatment_name": "Artificial liver therapy", "treatment_type": "Life support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]