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IRCT20201203049585N2 IRCT 2021-09-21 Esfahan University of Medical Sciences Evaluation of the effect of low-dose lung radiotherapy in the treatment of Covid 19 Comparative study of the effectiveness of low-dose lung radiation in comparison with placebo in the treatment of cancer patients with severe inflammatory phase of covid19 pneumonia 2021-09-05 anticipated 36 Complete https://irct.ir/trial/58173 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All patients wishing to participate in the study will be randomly divided into two groups A and B using SPSS20 software.To perform randomization by SPSS software, the "Data" option is selected from the SPSS software toolbar, then in the new window, the "Select cases" option is selected, then in the "Select" box, the "Random sample of cases" option is selected, and then the "Sample" option is selected. Then, in the new window, the "Exactly" option is selected and the number of patients in each group and the total number of samples are entered in the empty boxes, respectively (in this study, 18 and 36, respectively). Then the" Continue" and "Ok" options are selected and finally the randomly generated variables are randomly divided into two equal groups with codes 0 and 1 in the Data View page, which is conventionally assigned code 1 to the intervention group and code 0 to the control group. Patients will be randomly assigned to intervention or control groups by someone other than the lead researcher and statistical analyst, Blinding description: This study is performed by double-blind method. Patients participating in the study will be explained that they may be in one of two groups of doing radiotherapy or not doing radiotherapy. The process of radiotherapy, including patient and device setup, will be performed similarly for both groups, and whether or not radiation is received will be based on the patients' position in the intervention or control group. During the study process, participants, researchers, evaluators and Analyst will not know how people are positioned in the groups, and this information will be kept during the study and until the end of study, by coordinator of the intervention (radiotherapy technician). N/A Covid-19 Pneumonia. Intervention 1: Intervention group: Radiotherapy of both whole lungs in one fraction( a regular single session of radiotherapy) and at a dose of 5 Gy with treatment design by radiation-oncologist and by radiotherapy device equipped with tomotherapy system, in radiotherapy ward of Omid Hospital in Isfahan. Intervention 2: Control group: For patients in the control group, the treatment design and device set-up and the placement of patients in the treatment position will be done exactly like the intervention group, and instead of X-rays, laser light will be used on the treatment field (chest). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Nadia Najafizade
Motahari Ave, Omid Hospital
Isfahan Iran (Islamic Republic of) 8184917911 +98 31 3236 8006 nadianajafizade@yahoo.com Esfahan University of Medical Sciences scientific Nadia Najafizade
Motahari Ave, Omid Hospital
Isfahan Iran (Islamic Republic of) 8184917911 +98 31 3236 8006 nadianajafizade@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 J12.81 Pneumonia due to SARS-associated coronavirus Treatment - Devices Treatment - Devices Intervention group: Radiotherapy of both whole lungs in one fraction( a regular single session of radiotherapy) and at a dose of 5 Gy with treatment design by radiation-oncologist and by radiotherapy device equipped with tomotherapy system, in radiotherapy ward of Omid Hospital in Isfahan Control group: For patients in the control group, the treatment design and device set-up and the placement of patients in the treatment position will be done exactly like the intervention group, and instead of X-rays, laser light will be used on the treatment field (chest). Percentage of lung involvement on CT scan after treatment. Timepoint: At the beginning of the study and two months after radiotherapy. Method of measurement: High-resolution lung CT scan without contrast. Duration of hospitalization. Timepoint: During the patient's stay in the hospital. Method of measurement: The patient's hospital record. Reduction of IL-6. Timepoint: At the beginning of the study and two months after radiotherapy. Method of measurement: Laboratory tests. Reduction of CRP. Timepoint: At the beginning of the study and two months after radiotherapy. Method of measurement: Laboratory tests. Reduction of D-dimmer. Timepoint: At the beginning of the study and two months after radiotherapy. Method of measurement: Laboratory tests. Reduction of LDH. Timepoint: At the beginning of the study and two months after radiotherapy. Method of measurement: Laboratory tests. Reduction of Ferritin. Timepoint: At the beginning of the study and two months after radiotherapy. Method of measurement: Laboratory tests. Esfahan University of Medical Sciences Approved 2021-07-12 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Motahari Ave, Omid Hospital Isfahan Isfehan Iran (Islamic Republic of)