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| Name | Class |
|---|---|
| Nanjing Chest Hospital | UNKNOWN |
| Nanjing Medical University | OTHER |
| Central South University | OTHER |
| Zhongda Hospital |
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This phase II trial studies low-dose radiation therapy as a treatment for patients with severe COVID-19 pneumonia to improve clinical status.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control group | No Intervention | supportive care and standard of care drug therapies (i.e., glucocorticosteroids, Paxlovid, etc.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Dose Radiation Therapy | Radiation | 1.5Gy single treatment of whole-lung radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement | improvement of oxygen saturation in percentage | 28 days after radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature | Temperature in degrees (ËšC) | 28 days after radiation therapy |
| Heart Rate | Heart rate in beats per minutes | 28 days after radiation therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lirong Wu, M.D, Ph.D | Contact | 13701588737 | wulirong126@126.com | |
| Xia He, M.D, Ph.D | Contact | +86-25-83283563 | hexiabm@163.com |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| OTHER |
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| Systolic blood pressure | Systolic blood pressure in mm Hg Systolic blood pressure in mm Hg | 28 days after radiation therapy |
| Respirations Respirations Respirations Respirations Respirations Respirations | Respiratory rate in breaths per minute | 28 days after radiation therapy |
| FiO2 | Fi02 in percentage | 28 days after radiation therapy |
| PEEP Tidal volume Tidal volume | Positive end expiratory pressure (PEEP) in cm H20 | 28 days after radiation therapy |
| Overall survival Overall survival | Survival in percentage | 28 days after radiation therapy |
| Chest CT can | CT scans with volume of consolidation measured in cubic centimeters | 28 days after radiation therapy |
| Blood Test | 28 days after radiation therapy |
| Urine Test | 28 days after radiation therapy |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |