Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Low Dose Radiation therapy in
addition to standard
of care: The patients will be made to lie on a flat couch in comfortable position. A check portal image will be taken prior to treatme
Sponsors
Guru Hospitals
Eligibility
Inclusion criteria
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) 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Baseline Chest X-ray and on Days 3,7 CT chest Baseline and Day 14 | — |
Countries
India
Contacts
Public ContactMurugesh linga perumal
Guru Hospital
Outcome results
None listed