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| Column | Value |
|---|---|
| Trial registration number | NCT05682586 |
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Full text link
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
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First author
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
lqressh@hotmail.com |
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Registration date
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
2023-01-12 |
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Recruitment status
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Jan. 13, 2023, noon 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. 13, 2023, noon Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: the age ranges from 18 to 75 (inclusive), regardless of gender. patients diagnosed with severe and critical covid-19 pneumonia within one week, according to the chinese diagnostic criteria for covid-19 pneumonia in the diagnosis and treatment plan for covid-19 pneumonia (tentative ninth 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. 13, 2023, noon 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. 13, 2023, noon Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Shanghai East Hospital |
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Inclusion age min
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
75 |
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Countries
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Severe disease at enrollment |
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Severity scale
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
6: Severe disease at enrollment |
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Total sample size
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
60 |
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primary outcome
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Oxygenation index |
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Notes
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Jan. 13, 2023, noon 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": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |