COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49062

Pei Bin

xyxzyxzh@163.com

2020-02-04

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

On January 27, 2020, the general office of the national health commission and the office of the state administration of traditional Chinese medicine issued the pneumonia diagnosis and treatment plan for new coronavirus infection (trial version 4). 1. patients with severe 2019-ncov according to the clinical stage met any of the following criteria: (1) Respiratory distress, RR>=30 times/min, (2) In resting state, oxygen saturation is less than 93%, (3) Partial arterial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <=300mmHg (1mmHg= 0.133kpa), 2. according to the clinical stage of critical 2019-ncov, meet one of the following conditions: (1) Respiratory failure occurs and mechanical ventilation is required, (2) Shock, (3) Combined with other organ failure, intensive care unit is required, 3. other inclusion criteria: good compliance, willingness to cooperate with the study, and informed consent signed by the patient.

(1) diseases need to be differentiated from 2019-ncov, such as influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human partial pulmonary virus, SARS coronavirus and other known viral pneumonia, mycoplasma pneumoniae, chlamydia pneumonia, bacterial pneumonia and non-infectious diseases, (2) suspected case of 2019-ncov with no confirmed patient, (3) the clinical stage was mild: the clinical symptoms were mild, and no pneumonia was observed on imaging, (4) clinical stage: common type: fever, respiratory tract and other symptoms, and imaging findings of pneumonia, (5) have any known disease that seriously affects the immune system, such as a history of infection with the human immunodeficiency virus (HIV), or malignant tumors of the blood system or solid organs, or splenectomy, (6) other circumstances that the researcher considers inappropriate to participate in this study.

2

Xiangyang 1st People's Hospital

18

None

China

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

30

PSI;

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

Phase 0

[{"arm_notes": "", "treatment_id": 787, "treatment_name": "Mesenchymal 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"}]