Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

Jiangsu Cancer Institute & Hospital40 enrolled

Overview

This phase II trial studies low-dose radiation therapy as a treatment for patients with severe COVID-19 pneumonia to improve clinical status.

PRIMARY OBJECTIVE: I. To compare treatment of severe COVID-19 pneumonia between supportive care and standard of care drug therapies versus supportive care and standard of care drug therapies plus low-dose, whole-lung radiation therapy OUTLINE: Patients undergo 1.5Gy of single low-dose radiation therapy. After completion of study treatment, patients are followed up at days 1-7, and 14 after last dose of intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Pneumonia

Interventions

Low-Dose Radiation TherapyRADIATION

1.5Gy single treatment of whole-lung radiation therapy

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have had a positive test confirming the diagnosis of COVID-19; 2. Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrollment); 3. Have visible consolidations/ground glass opacities on chest x-ray or computed tomography; 4. Have been on ventilator support for no longer than 5 calendar days prior to the schedule date of delivery of low-dose radiation therapy; 5. They voluntarily participate in this clinical trial, gave informed consent and signed the informed consent form. Exclusion Criteria: 1. Have received chest radiotherapy before 2. Bacteria, fungi and other infections other than novel coronavirus infection; 3. 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); 4. Mental retardation, mental disorders; 5. Planned pregnancy, pregnancy, lactation women and during the trial; 6. Allergy constitution or allergy to the drug ingredients and excipients of this test; 7. Participated in other clinical trials in the recent 1 month; 8. The Investigator does not considered appropriate to participate in this clinical trial.