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Trial - IRCT20201203049585N2


Column Value
Trial registration number IRCT20201203049585N2
Full text link
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shaghayegh Haghjooy Javanmard

Contact
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

sh_haghjoo@med.mui.ac.ir

Registration date
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-09-21

Recruitment status
Last imported at : Feb. 3, 2022, 1:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Over 18 years Having cancer Covid-19 pneumonia that has been confirmed by PCR test Lung involvement more than 50% that has been confirmed by HRCT Interleukin-6 ≥ 40 or establishing two of the following criteria: D-dimmer ≥ 1000 CRP ≥ 100 LDH ≥ 300 Ferritin ≥ 500 Not a candidate for ICU admission

Exclusion criteria
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Any contraindication for radiotherapy Current chest radiotherapy Active pulmonary metastasis A history of previous lung radiotherapy Being pregnant The patient's WBC be less than 1000 in the day before the intervention Unable to understand the conditions of the intervention, in the terms of mental health

Number of arms
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Esfahan University of Medical Sciences

Inclusion age min
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

36

primary outcome
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Percentage of lung involvement on CT scan after treatment

Notes
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Not reported

Arms
Last imported at : Sept. 21, 2021, 2:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 1915, "treatment_name": "Probiotic streptococcus salivarius k12", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]