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Trial - NCT04324996


Column Value
Trial registration number NCT04324996
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Min Liu, A.B

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

gwzxliumin@foxmail.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-03-27

Recruitment status
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: sign written informed consent; age ≥18 years; conforms to the ncp critical and critical diagnostic standards, namely "pneumonitis diagnosis and treatment scheme for new coronavirus infection (trial version 6)". comprehensive judgment based on epidemiological history, clinical manifestations and etiological examination; the course of disease is within 14 days after the onset of illness; willing to collect nasopharyngeal or oropharyngeal swabs before administration.

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

patients participating in clinical trials of other drugs; pregnant or lactating women; alt / ast> 5 times uln, or neutrophils <0.5 * 109 / l, or platelets less than 50 * 109 / l; expected survival time is less than 1 week; a clear diagnosis of rheumatism-related diseases; long-term oral anti-rejection drugs or immunomodulatory drugs; patients hypersensitive to nk cells and their preservation solution.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

5

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Chongqing Public Health Medical Center

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

90

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Side effects in the treatment group;Clinical response

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1/Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 867, "treatment_name": "Natural killer cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 628, "treatment_name": "Il15-nk cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 897, "treatment_name": "Nkg2d car-nk cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 14, "treatment_name": "Ace2 car-nk cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 896, "treatment_name": "Nkg2d-ace2 car-nk cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}]