Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

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

Detailed Description
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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.

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

Conditions
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COVID-19 Pneumonia

Intervention / Treatment
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* Radiation: Low-Dose Radiation Therapy


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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) plus 1.5Gy single treatment of whole-lung radiation therapy | Radiation: Low-Dose Radiation Therapy<br>* 1.5Gy single treatment of whole-lung radiation therapy<br>|
| No Intervention: Control group<br>supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | improvement of oxygen saturation in percentage | 28 days after radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature | Temperature in degrees (˚C) | 28 days after radiation therapy | 
| Heart Rate | Heart rate in beats per minutes | 28 days after radiation therapy | 
| Systolic blood pressure | Systolic blood pressure in mm Hg Systolic blood pressure in mm Hg | 28 days after radiation therapy | 
| Respirations Respirations Respirations Respirations Respirations Respirations | Respiratory rate in breaths per minute | 28 days after radiation therapy | 
| FiO2 | Fi02 in percentage | 28 days after radiation therapy | 
| PEEP Tidal volume Tidal volume | Positive end expiratory pressure (PEEP) in cm H20 | 28 days after radiation therapy | 
| Overall survival Overall survival | Survival in percentage | 28 days after radiation therapy | 
| Chest CT can | CT scans with volume of consolidation measured in cubic centimeters | 28 days after radiation therapy | 
| Blood Test |  | 28 days after radiation therapy | 
| Urine Test |  | 28 days after radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Radiation Therapy, Pneumonia