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Trial - NCT04336254


Column Value
Trial registration number NCT04336254
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04336254

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

Qingsong Ye, PhD,DDS

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

qingsongye@foxmail.com

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

2020-04-07

Recruitment status
Last imported at : March 15, 2023, 4 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 : Oct. 26, 2020, 11:31 p.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: aged 18-65 years; voluntarily participate in this clinical trial and sign off "informed consent form"; diagnosed with severe pneumonia of covid: respiratory distress, rr >30 times / min; resting oxygen saturation of 93% or less; arterial partial pressure of oxygen / oxygen concentration 300mmhg; sars-cov-2 nucleic acid test was positive. chest imaging confirm covid-19 featured lesions in lung.

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

receive any clinical trial drug treatment for covid-2019 within 30 days before the screening assessment; severe liver disease (e.g., child pugh score >=c or ast> 5 times of the upper limit); patients with known severe renal insufficiency (estimated glomerular filtration rate <=30ml / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis; co-infection of hiv, hepatitis b, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses; female patients who have no sexual protection in the last 30 days prior to the screening assessment; pregnant or lactating women or women using estrogen contraception; patients who are planning to become pregnant during the study period or within 6 months after the end of the study period; other conditions that the researchers consider not suitable for participating in this clinical trial.

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

Renmin Hospital of Wuhan University

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

65

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

Severe disease at enrollment

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

6: Severe disease at enrollment

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

20

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

TTCI

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": 64, "treatment_name": "Allogeneic human dental pulp stem cells", "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"}]