Official Title
Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Multicenter Phase II Prospective Randomized Controlled Study
Brief Summary

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

Detailed Description

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.

Unknown status
COVID-19 Pneumonia

Radiation: Low-Dose Radiation Therapy

1.5Gy single treatment of whole-lung radiation therapy

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 40 Years ~ Maximum: 85 Years
Locations

Not Provided

Contacts

Lirong Wu, M.D, Ph.D
13701588737
wulirong126@126.com

Xia He, M.D, Ph.D
+86-25-83283563
hexiabm@163.com

Not Provided

Jiangsu Cancer Institute & Hospital
NCT Number
Keywords
Covid-19
Radiation Therapy
Pneumonia
MeSH Terms
COVID-19
Pneumonia