Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

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

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.

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.