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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Radiation: Low-Dose Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lirong Wu, M.D, Ph.D; Phone Number: 13701588737; Email: wulirong126@126.com
• Study Contact Backup: Name: Xia He, M.D, Ph.D; Phone Number: +86-25-83283563; Email: hexiabm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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; 1.5Gy single treatment of whole-lung radiation therapy
No Intervention: Control group; supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangsu Cancer Institute & Hospital
• Collaborators: Zhongda Hospital; Central South University; Nanjing Chest Hospital; The Affiliated BenQ Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Pneumonia; COVID-19; Radiation Therapy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: LDRT-SCov19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No