Low dose Radiotherapy for COVID-19 using Linear accelerator

Phase 2

Not yet recruiting

Brief Summary: The World Health Organization (WHO) has declared coronavirus disease 2019 (COVID-19) as pandemic in March 2020. Currently there is no vaccine or specific effective treatment for COVID-19. The major cause of death in COVID-19 is severe pneumonia leading to respiratory failure. Radiation in low doses (<100 cGy) has been known for its anti-inflammatory effect and therefore, low dose radiation therapy (LDRT) to lungs can potentially mitigate the severity of pneumonia and reduce mortality. We conducted a single arm trial to study the feasibility and clinical efficacy of LDRT to lungs in the management of patients with COVID-19.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

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	6 hours,day 1,2,3,4,7
patients with COVID-19 by improving the Spo2 levels 48-72h after treatment with respect to baseline pre-irradiation measurement	6 hours,day 1,2,3,4,7

Secondary Outcome Measures

Name	Time	Method
The secondary objectives include assessing the	safety of bilateral pulmonary LDRT using a

Locations (1): Surya Global Multi Speciality Hospital
🇮🇳
Godavari, ANDHRA PRADESH, India
Surya Global Multi Speciality Hospital
🇮🇳Godavari, ANDHRA PRADESH, India
Dr Vasireddy Abhinav
Principal investigator
8247707221
abhi6877@gmail.com