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Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

Sponsor
Jiangsu Cancer Institute & Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05694962
Collaborator
Nanjing Chest Hospital (Other), The Affiliated BenQ Hospital of Nanjing Medical University (Other), Central South University (Other), Zhongda Hospital (Other)
40
Enrollment
2
Arms
23
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Low-Dose Radiation Therapy
 Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Multicenter Phase II Prospective Randomized Controlled Study
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.)

Outcome Measures

Primary Outcome Measures

  1. Clinical improvement [28 days after radiation therapy]

    improvement of oxygen saturation in percentage

Secondary Outcome Measures

  1. Temperature [28 days after radiation therapy]

    Temperature in degrees (˚C)

  2. Heart Rate [28 days after radiation therapy]

    Heart rate in beats per minutes

  3. Systolic blood pressure [28 days after radiation therapy]

    Systolic blood pressure in mm Hg Systolic blood pressure in mm Hg

  4. Respirations Respirations Respirations Respirations Respirations Respirations [28 days after radiation therapy]

    Respiratory rate in breaths per minute

  5. FiO2 [28 days after radiation therapy]

    Fi02 in percentage

  6. PEEP Tidal volume Tidal volume [28 days after radiation therapy]

    Positive end expiratory pressure (PEEP) in cm H20

  7. Overall survival Overall survival [28 days after radiation therapy]

    Survival in percentage

  8. Chest CT can [28 days after radiation therapy]

    CT scans with volume of consolidation measured in cubic centimeters

  9. Blood Test [28 days after radiation therapy]

  10. Urine Test [28 days after radiation therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. He Xia, Vice President, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier:
NCT05694962
Other Study ID Numbers:
  • LDRT-SCov19
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. He Xia, Vice President, Jiangsu Cancer Institute & Hospital
COVID-19
Radiation Therapy
Pneumonia
Additional relevant MeSH terms:
COVID-19
Pneumonia

Study Results

No Results Posted as of Jan 25, 2023