Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

NCT ID: NCT05694962

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-12-31

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.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Low-Dose Radiation Therapy

Intervention Type: RADIATION

1.5Gy single treatment of whole-lung radiation therapy

Control group

supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low-Dose Radiation Therapy

1.5Gy single treatment of whole-lung radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Chest Hospital

UNKNOWN

Sponsor Role: collaborator

The Affiliated BenQ Hospital of Nanjing Medical University

UNKNOWN

Sponsor Role: collaborator

Central South University

OTHER

Sponsor Role: collaborator

Zhongda Hospital

OTHER

Sponsor Role: collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. He Xia

Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lirong Wu, M.D, Ph.D

Role: CONTACT

wulirong126@126.com

13701588737

Xia He, M.D, Ph.D

Role: CONTACT

hexiabm@163.com

+86-25-83283563

Other Identifiers

LDRT-SCov19

Identifier Type: -

Identifier Source: org_study_id