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Trial - NCT05694962


Column Value
Trial registration number NCT05694962
Full text link
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Lirong Wu, M.D, Ph.D

Contact
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

wulirong126@126.com

Registration date
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

2023-01-23

Recruitment status
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

inclusion criteria: have had a positive test confirming the diagnosis of covid-19; have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment); have visible consolidations/ground glass opacities on chest x-ray or computed tomography; have been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy; they voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form.

Exclusion criteria
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

have received chest radiotherapy before bacteria, fungi and other infections other than novel coronavirus infection; combined with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic and endocrine system or immune system diseases (the upper limit of liver function alt and ast> normal reference value, the upper limit of scr> normal reference value, poor blood glucose control); mental retardation, mental disorders; planned pregnancy, pregnancy, lactation women and during the trial; allergy constitution or allergy to the drug ingredients and excipients of this test; participated in other clinical trials in the recent 1 month; the investigator does not considered appropriate to participate in this clinical trial.

Number of arms
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Jiangsu Cancer Institute & Hospital

Inclusion age min
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

40

Inclusion age max
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

40

primary outcome
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Clinical improvement

Notes
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Jan. 24, 2023, 8 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 746, "treatment_name": "Low dose radiation therapy", "treatment_type": "Radiation therapy", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]