ow dose lung X-ray therapy for COVID-19

Phase 2

Completed

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

Registration Number: CTRI/2020/10/028597

Lead Sponsor: Harshamitra Superspecialty Cancer Centre and Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 61

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

Primary Outcome Measures

Name	Time	Method
The primary end-point will be to evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PaO2-FiO2 by 20% measured 48-72h after treatment with respect to baseline pre-irradiation measurementTimepoint: 6 hours,day 1, day 2, day 3, day 4, day 7

Secondary Outcome Measures

Name	Time	Method
The secondary objectives include assessing the safety of bilateral pulmonary LDRT using a portable X-ray therapy machine, evaluating the improvement of the radiological image, overall mortality rate at 28 days after irradiation and measuring the level of CRP, IL-6, D-dimer, Total Lymphocyte count, Absolute neutrophil count and Neutrophil to Lymphocyte ratio and documenting the incidence of adverse events and their grade if applicableTimepoint: Blood tests on Days 1,4,7,14,30 <br/ ><br>Baseline Chest X-ray and on Days 3,7 <br/ ><br>CT chest Baseline and Day 14