Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia

COVID-19 Pneumonia Clinical Trial

Official title:

Low-Dose Radiation Therapy for Severe COVID-19 Pneumonia: A Multicenter Phase II Prospective Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05694962
• Other study ID #: LDRT-SCov19
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Lirong Wu, M.D, Ph.D
• Phone: 13701588737
• Email: wulirong126[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies low-dose radiation therapy as a treatment for patients with severe COVID-19 pneumonia to improve clinical status.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Pneumonia

Intervention

Radiation:
• Low-Dose Radiation Therapy
1.5Gy single treatment of whole-lung radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital	Central South University, Nanjing Chest Hospital, The Affiliated BenQ Hospital of Nanjing Medical University, Zhongda Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	improvement of oxygen saturation in percentage	28 days after radiation therapy
Secondary	Temperature	Temperature in degrees (°C)	28 days after radiation therapy
Secondary	Heart Rate	Heart rate in beats per minutes	28 days after radiation therapy
Secondary	Systolic blood pressure	Systolic blood pressure in mm Hg Systolic blood pressure in mm Hg	28 days after radiation therapy
Secondary	Respirations Respirations Respirations Respirations Respirations Respirations	Respiratory rate in breaths per minute	28 days after radiation therapy
Secondary	FiO2	Fi02 in percentage	28 days after radiation therapy
Secondary	PEEP Tidal volume Tidal volume	Positive end expiratory pressure (PEEP) in cm H20	28 days after radiation therapy
Secondary	Overall survival Overall survival	Survival in percentage	28 days after radiation therapy
Secondary	Chest CT can	CT scans with volume of consolidation measured in cubic centimeters	28 days after radiation therapy
Secondary	Blood Test		28 days after radiation therapy
Secondary	Urine Test		28 days after radiation therapy