COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=51904

Feng Ganzhu

zhu1635253@163.com

2020-04-02

Recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

(1) Aged 18 to 90 years old, male or female, (2) Patients with a definite diagnosis of new type of coronavirus pneumonia, (3) Expected survival time > 10 days, (4) Serology: HIV antibody negative, hepatitis B surface antigen, e antigen negative, hepatitis C antibody negative, female patients with negative pregnancy test, ALT, AST <=2.5 ULN, for patients with liver metastases, ALT, AST <=5 ULN, ALP <=2.5 ULN, serum urea nitrogen and creatinine <=1.5 ULN, serum total bilirubin <1.5 times the upper limit of normal, (6) Patients or their legal representatives can understand and voluntarily sign informed consent.

1. With any autoimmune disease, 2. with malignant tumors, 3. Participated in other clinical studies within three months before entering the group, 4. Severe allergic history, allergic to T cell therapy products or other biological agents, 5. Pregnant, planning to become pregnant or lactating women, 6. Patients with severe systemic diseases who are not suitable for entering the study, including but not limited to severe liver dysfunction, severe coagulation disorders, severe mental diseases, etc., 7. Previously received other stem cell therapy, had received CIK cell therapy within two months, 8. Researchers believe that other conditions should not be included in this trial.

2

Huangshi Hospital of Traditional Chinese Medicine (Municipal Infectious Disease Hospital)

18

90

China

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

36

Chest Imaging;lung function;ADL;

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

Phase 1

[{"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"}]