NCT05694962

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 20, 2023

Last Update Submit

January 22, 2023

Conditions

COVID-19 Pneumonia

Keywords

COVID-19Radiation TherapyPneumonia

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement

    improvement of oxygen saturation in percentage

    28 days after radiation therapy

Secondary Outcomes (10)

  • Temperature

    28 days after radiation therapy

  • Heart Rate

    28 days after radiation therapy

  • Systolic blood pressure

    28 days after radiation therapy

  • Respirations Respirations Respirations Respirations Respirations Respirations

    28 days after radiation therapy

  • FiO2

    28 days after radiation therapy

  • +5 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Low-Dose Radiation TherapyRADIATION

1.5Gy single treatment of whole-lung radiation therapy

Treatment group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19Pneumonia

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Lirong Wu, M.D, Ph.D

CONTACT

13701588737wulirong126@126.com

Xia He, M.D, Ph.D

CONTACT

+86-25-83283563hexiabm@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 23, 2023

Study Start

January 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share