Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

Phase 2

Not yet recruiting

• Conditions: COVID-19 Pneumonia
• Interventions: Radiation: Low-Dose Radiation Therapy

• Registration Number: NCT05694962
• Lead Sponsor: Jiangsu Cancer Institute & Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2023-01
• Study Start: 2023-01
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-22
• Study First Posted: 2023-01-23
• Last Update Posted: 2023-01-25
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Low-Dose Radiation Therapy	supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) plus 1.5Gy single treatment of whole-lung radiation therapy

Primary Outcome Measures

Name	Time	Method
Clinical improvement	28 days after radiation therapy	improvement of oxygen saturation in percentage

Secondary Outcome Measures

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