COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=50199

Ye Xiaoqun

511201663@qq.com

2020-03-18

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Patients are eligible for inclusion if they meet all of the following criteria within 5-7 days after the first admission to the ICU. 2. The patients met the diagnostic criteria of 2019-nCoV pneumonia (new coronavirus infection) pneumonia treatment plan (Fifth version), the National Health Office [2020] No.103., 3. The primary disease is 2019 nCoV infection, 4. Respiratory distress, RP >=30 times/unit, 5. Under resting state, blood oxygen saturation <=93%, 6. PaO2 / FiO2 <=300nnhg (1mmhg = 0.133kpa), 7. Imaging data suggest bilateral lesions 8. Volunteer to participate in clinical research, understand and sign informed consent.

1. sNCP caused by other non-viral infections (such as trauma), 2. WHO grade III or IV pulmonary hypertension, 3. Malignant tumor in lung and other systems, 4. Lactating women or screening women with positive blood pregnancy test, 5. Idiopathic IgA deficiency, 6. Recent cardiovascular and cerebrovascular events (3 months), 7. Lung transplanted patients, 8. HIV positive patients, 9. According to the researcher's judgment, these subjects will be excluded because of some causes, such as any disease, treatment, or laboratory abnormal history or current evidence, which may confound the results of the study, interfere with the subject's participation in the study procedure, or be not in the best interest of the subject's participation in the study.

2

The Second Affiliated Hospital of Nanchang University

4

80

China

Severe disease at enrollment

6: Severe disease at enrollment

20

Changes of serum inflammatory factors;Patient death risk;Drug related adverse reactions and events;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 1

[{"arm_notes": "", "treatment_id": 1645, "treatment_name": "Natural killer cells+stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]