COVID-19 Pneumonia
Conditions
Keywords
COVID-19, Radiation Therapy, Pneumonia
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.
Interventions
RADIATIONLow-Dose Radiation Therapy
1.5Gy single treatment of whole-lung radiation therapy
Sponsors
Nanjing Chest Hospital
The Affiliated BenQ Hospital of Nanjing Medical University
Central South University
Zhongda Hospital
Jiangsu Cancer Institute & Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | 28 days after radiation therapy | improvement of oxygen saturation in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | 28 days after radiation therapy | Heart rate in beats per minutes |
| Systolic blood pressure | 28 days after radiation therapy | Systolic blood pressure in mm Hg Systolic blood pressure in mm Hg |
| Respirations Respirations Respirations Respirations Respirations Respirations | 28 days after radiation therapy | Respiratory rate in breaths per minute |
| FiO2 | 28 days after radiation therapy | Fi02 in percentage |
| Temperature | 28 days after radiation therapy | Temperature in degrees (˚C) |
| 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 |
| Blood Test | 28 days after radiation therapy | — |
| Urine Test | 28 days after radiation therapy | — |
| PEEP Tidal volume Tidal volume | 28 days after radiation therapy | Positive end expiratory pressure (PEEP) in cm H20 |
Contacts
Primary ContactLirong Wu, M.D, Ph.D
Backup ContactXia He, M.D, Ph.D
Outcome results
None listed