Irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy

COVID-19

Participants will undergo irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy

Single fraction whole lung radiotherapy

Radiation Oncology Department, ASST SpedaliCivili, Brescia

COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19)

Pilot Study on the Feasibility of Low Dose Radiotherapy for SARS-Cov-2 Pneumonitis (COVID-19 Low Dose Radiotherapy - COLOR 19)

Evaluation of the feasibility of low-dose radiotherapy treatment of SARS-Cov2 pneumonia, for the purpose of the subsequent implementation of a phase II study; lenght of hospital stay will be recorded

Evaluation of the feasibility of low-dose radiotherapy treatment of SARS-Cov2 pneumonia; the number of intensive care unit admissions will be recorded

Variation of the patient's score according to the Brescia COVID-19 Respiratory Severity Scale (minimum value 0, maximum value 8; higher scores mean a worse outcome) with baseline, assessed at 3, 6 and 10 days after treatment.

Evaluation of the safety and tolerance of the low-dose radiotherapy treatment of SARS-Cov2 ( using the CTCAE 5.0 scale)

Variation of the radiological findings, assessed by chest X-ray (performed 3 and 6 days after treatment) and defined according to the Brixia scoring system (0-18 scale, with 18 meaning the worse outcome)

All Individual Participant Data that underlie results in the publication

Stefano Maria Magrini

Prof

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Vitamin C Deficiency

Smoking

Surgery

Surgery--Complications

Wound

Wound Complication

Wound Infection

Wound Dehiscence

Wound of Skin

Mandible Fracture

Mandible Open Fracture

Mandible Closed Fracture

Mandibular Fractures

Ascorbic Acid Deficiency

Oxidative Stress

Inflammation

Just after induction of anesthesia in the OR, subjects will be administered a single intravenous (IV) dose of Vitamin C at 66mg/kg/hr for 2 hours during surgery. Post-operatively (beginning the morning after surgery) Vitamin C Treatment Group subjects will receive a 4 week prescription of oral, liquid Vitamin C, 500mg by mouth two times a day. These dosages are known to be safe and effective.89-91

Vitamin C

Subjects will receive IV placebo (normal saline) identically packaged. Post-operatively Placebo Control Treatment Group participants will receive a 4-week prescription of the aqueous solution base used for the treatment group without the active component (Vitamin C).

Placebo

Hennepin Healthcare Research Institute

The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients

The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients: A Double Blind, Placebo-controlled Randomized Clinical Trial

Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood serum.

Biomarker of soft tissue repair. Measured in picogram/milliliter (pg/ml) in blood

Biomarker of soft tissue repair. Measured in nanogram/milliliter (ng/ml) in blood

Biomarker of soft tissue repair. Measured in micro Molar uM in blood

Biomarker of soft tissue repair. Measured in nanomol/microliter (nmol/ul) in blood

Biomarker of bone repair. Measured in enzyme unit/liter (U/L) in blood

Biomarker of bone repair. Measured in picogram/milliliter (pg/ml) in blood

Biomarker of bone repair. Measured in nanogram/milliliter (ng/ml) in blood

Vitamin C levels. Measured in nanomols (nmmol) in blood serum

Biomarker of tobacco exposure. Measured in nanograms/milliliter (mg/ml) in blood serum.

Wounds are scored from photographs using the InCISE wound score developed by the investigator.

proteinase/hypoxia

COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19)

The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients

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