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Trial - NCT04276896


Column Value
Trial registration number NCT04276896
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04276896

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

Lung-Ji Chang, PhD

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

c@szgimi.org

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

2020-02-19

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

Recruiting

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

nonRCT

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

Non-randomized

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

Single group assignment

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

Open label

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

multi-center

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

Treatment

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

inclusion criteria: - laboratory (rt-pcr) confirmed covid-19 infection in throat swab and/or sputum and/or lower respiratory tract samples; - the interval between the onset of symptoms and randomized is within 7 days. the onset of symptoms is mainly based on fever. if there is no fever, cough or other related symptoms can be used; - white blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl; - human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv) or tuberculosis (tb) test is negative; - sign the informed consent form on a voluntary basis;

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

- subject infected with hcv (hcv antibody positive), hbv (hbsag positive), hiv (hiv antibody positive), or htlv (htlv antibody positive). - subject is albumin-intolerant. - subject with life expectancy less than 4 weeks. - subject participated in other investigational somatic cell therapies within past 30 days. - subject with positive pregnancy test result. - researchers consider unsuitable.

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

1

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

Shenzhen Geno-Immune Medical Institute

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

0

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

80

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

Infected patients

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

N/A

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

100

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

Clinical improvement based on the 7-point scale;Lower Murray lung injury score

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": "1", "treatment_id": 1747, "treatment_name": "Lv-smenp-dc vaccine", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}]