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| Column | Value |
|---|---|
| Trial registration number | NCT05689008 |
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Full text link
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
lqressh@hotmail.com |
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Registration date
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
2023-01-18 |
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Recruitment status
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Open 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 : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
inclusion criteria: the age ranges from 18 to85 (inclusive), regardless of gender. patients who still have refractory hypoxia after sufficient standard treatment for severe and critical covid-19 pneumonia following the suggestion of the chinese diagnostic criteria for covid-19 pneumonia in the diagnosis and treatment plan for covid-19 pneumonia (tentative tenth edition). 20kg/m2≤body mass index(bmi)≤30 kg/m2. volunteer to participate in this clinical study and sign the written informed consent |
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Exclusion criteria
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. t lymphocyte abnormality (allogeneic may be considered, depending on clinical opinion), hiv positive. highly allergic or have a history of severe allergy, especially interleukin-2 allergy. pregnant and lactating women. patients with severe autoimmune disease history; allergies to all biological reagents in this treatment, such as interleukin-2. patients with serious complications, including chronic cardiac insufficiency (nyha cardiac function grading assessment of cardiac function grade iii - iv), chronic renal insufficiency (ckd stage 3 and above); chronic liver insufficiency (child-pugh score>7); patients with malignant tumors. patients with pulmonary embolism or acute coronary syndrome. patients with severe organ dysfunction caused by other diseases. there are other situations that the researcher thinks are not suitable to participate in this clinical study |
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Number of arms
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Shanghai East Hospital |
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Inclusion age min
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
85 |
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Countries
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
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Severity scale
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
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Total sample size
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
60 |
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primary outcome
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Oxygenation index |
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Notes
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Jan. 20, 2023, 8 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1334, "treatment_name": "Umbilical cord mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |