ow Dose Radiotherapy for COVID-19 Pneumonia using a Linear accelerator

Phase 2

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

Registration Number: CTRI/2021/06/033911

Lead Sponsor: Guru Hospitals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients with confirmed diagnosis of SARS-Cov2 infection by RT-PCR on nasopharyngeal swab and / or bronchoalveolar lavage (BAL)

2.moderate to severe dyspnoea, respiratory frequency >= 30/min, oxygen saturation with supplemental O2 supply (SpO2) < 92%, PaO2/FiO2 ratio or PaFiO2 ratio between 200 to 300 or SpO2/FiO2 ratio < 315 if PaO2 is not available

3.laboratory abnormalities such as C-reactive protein (CRP) >100 mg/L, D-dimer >1000 ng/ml, IL-6 >40 IU or suspected cytokine release syndrome.

4.first and second criteria are mandatory and third is optional

Exclusion Criteria

1.Prior lobectomy or pneumonectomy

2.contraindication to radiation (Example: Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia)

3.previous history of radiation to thoracic organs

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

6.Pregnancy.

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 using a Linear accelerator as an adjunctive treatment for patients with COVID-19 pneumonia by improving the PaO2-FiO2 by 20% measured 48-72h after treatment with respect to baseline pre-irradiation measurement.Timepoint: 48-72h after treatment

Secondary Outcome Measures

Name	Time	Method
The secondary objectives include assessing the <br/ ><br>safety of bilateral pulmonary LDRT using a <br/ ><br>portable X-ray therapy machine, evaluating the <br/ ><br>improvement of the radiological image, overall <br/ ><br>mortality rate at 28 days after irradiation and <br/ ><br>measuring the level of CRP, IL-6, D-dimer, Total <br/ ><br>Lymphocyte count, Absolute neutrophil count <br/ ><br>and Neutrophil to Lymphocyte ratio and <br/ ><br>documenting the incidence of adverse events <br/ ><br>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