ow dose X-ray therapy for COVID-19

Phase 2

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/04/033158
• Lead Sponsor: Harshamitra Superspecialty Cancer Centre and Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Adult patients with RT-PCR proven COVID-19 with moderate to severe pneumonia with fewer than 14 days of symptom onset that warranted hospitalization and currently receiving standard medication for COVID-19 at appropriate doses which would include, among others, antivirals, corticosteroids, or anti-IL-6 tocilizumab and 2. moderate to severe dyspnoea, respiratory frequency equal to or greater than 30/min, oxygen saturation without supplemental O2 supply SpO2 94% or less, PaO2/FiO2 ratio or PaFiO2 ratio between 200 to 300 or SpO2/FiO2 ratio 315 or less if PaO2 is not available and/or 3. laboratory abnormalities such as C-reactive protein > 100 mg/L or D-dimer > 1000 ng/ml or IL-6 > 50 IU or suspected cytokine release syndrome (Criteria 1 and 2 are mandatory and 3 is optional)

Exclusion Criteria

1. Patients on ventilators (invasive/non-invasive)

2. Prior lobectomy or pneumonectomy

3. Prior thoracic radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment

4. Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radio sensitization within 14 days or 5 half-lives, whichever is greater, of enrollment, e.g., bleomycin, gemcitabine

5. Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment

6. Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class 3 (or higher) congestive heart failure

7. History of bone marrow or solid organ transplantation

8. Known history of autoimmune collagen vascular disease, e.g., scleroderma

9. Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia

10. Pregnancy

11. Inability to be positioned supine and flat for radiation planning and delivery

12. Inability to provide informed consent or lack of an authorized representative who can provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified