This phase II trial studies low-dose radiation therapy as a treatment for patients withsevere 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.
Radiation: Low-Dose Radiation Therapy
1.5Gy single treatment of whole-lung radiation therapy
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.
Not Provided
Lirong Wu, M.D, Ph.D
13701588737
wulirong126@126.com
Xia He, M.D, Ph.D
+86-25-83283563
hexiabm@163.com
Not Provided