Clinical trial NCT05694962: Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia
Official title: Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Multicenter Phase II Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19 Pneumonia
Keywords: COVID-19
Radiation Therapy
Pneumonia
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
Collaborators: name: Nanjing Chest Hospital
name: The Affiliated BenQ Hospital of Nanjing Medical University
name: Central South University
name: Zhongda Hospital
First posted: 2023-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical improvement
timeFrame: 28 days after radiation therapy
Secondary outcomes:
measure: Temperature
timeFrame: 28 days after radiation therapy
measure: Heart Rate
timeFrame: 28 days after radiation therapy
measure: Systolic blood pressure
timeFrame: 28 days after radiation therapy
measure: Respirations Respirations Respirations Respirations Respirations Respirations
timeFrame: 28 days after radiation therapy
measure: FiO2
timeFrame: 28 days after radiation therapy
measure: PEEP Tidal volume Tidal volume
timeFrame: 28 days after radiation therapy
measure: Overall survival Overall survival
timeFrame: 28 days after radiation therapy
measure: Chest CT can
timeFrame: 28 days after radiation therapy
measure: Blood Test
timeFrame: 28 days after radiation therapy
measure: Urine Test
timeFrame: 28 days after radiation therapy
Other outcomes:
Locations:
Study officials:
References: