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| Column | Value |
|---|---|
| Trial registration number | NCT04339660 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
447822853@qq.com |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-09 |
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Recruitment status
Last imported at : April 5, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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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: male or female, 18 years old ≤ age ≤ 75years old; ct image is characteristic of 2019 novel coronavirus pneumonia; laboratory confirmation of 2019-ncov infection by reverse transcription polymerase chain reaction (rt-pcr); in compliance with the 2019-ncov pneumonia diagnosis standard (according to the novel coronavirus infection pneumonia diagnosis and treatment program (trial implementation version 6) issued by the national health and medical commission, and who 2019 new coronavirus guidelines standards): (a) increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (b) in resting state, means oxygen saturation ≤93%; (c) partial pressure of arterial oxygen (pao2) / fraction of inspired oxygen (fio2) ≤300 mmhg (1mmhg = 0.133kpa); participant or the authorized agent signed the informed consent form. agree to collect clinical samples. |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
malignant disease in the past five years; participant with no hope of survival were clinically predicted and only received hospice care, or those who were in a deep coma and did not respond to supportive treatment measures within three hours of admission. participant who are participating in other clinical trials or who have participated in other clinical trials within 3 months. cases of severe shock and respiratory failure. |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Puren Hospital Affiliated to Wuhan University of Science and Technology |
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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 |
75 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Severe disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
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Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
30 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
The immune function (TNF-α 、IL-1β、IL-6、TGF-β、IL-8、PCT、CRP);Blood oxygen saturation |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1327, "treatment_name": "Uc-mscs", "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"}] |