COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49674

Robert Chunhua Zhao/Ronghua Jin

zhaochunhua@vip.163.com

2020-02-18

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

1. Male or female, 18-95 years old, 2. 2019 new coronavirus nucleic acid test positive, 3. Diagnosed as moderate to severe cases of new coronavirus pneumonia in 2019, which meets the following clinical manifestations: 4. With fever and respiratory symptoms, imaging shows pneumonia, 5. A severe case diagnosed with 2019 new coronavirus pneumonia, that is, any of the following: (1) Increased breathing rate (>=30 beats / min), difficulty breathing, cyanosis of lips, (2) In the resting state, it means that oxygen saturation <=93%, or blood oxygen drops rapidly, (3) Arterial blood oxygen partial pressure (PaO2) / oxygen concentration (FiO2) <=300mmHg (1mmHg = 0.133kPa), 6. I or the authorized agent signed the informed consent form, 7. Agree to collect clinical samples.

1. Malignant disease in the past five years, 2. The clinical prediction is that there is no hope for survival, only cases of hospice care, or cases of deep coma that do not respond to supportive treatment measures within three hours of admission, 3. Subjects who are participating in other clinical trials or within 3 months, 4. Cases of very severe shock and respiratory failure.

2

Institute of Basic Medical Sciences; Chinese Academy of Medical Sciences

18

95

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

120

Improved respiratory system function (blood oxygen saturation) recovery time;

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

Phase 1/Phase 2

[{"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": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]