COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48730

Vivek Sundaram

drsasipriyahmitra@gmail.com

2020-10-23

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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. <br/ >and <br/ >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 <br/ >and/or <br/ >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 <br/ > <br/ >(Criteria 1 and 2 are mandatory and 3 is optional)

1. Patients on ventilators (invasive/non-invasive) <br/ >2. Prior lobectomy or pneumonectomy <br/ >3. Prior thoracic radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment <br/ >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 <br/ >5. Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment <br/ >6. Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class 3 (or higher) congestive heart failure <br/ >7. History of bone marrow or solid organ transplantation <br/ >8. Known history of autoimmune collagen vascular disease, e.g., scleroderma <br/ >9. Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia <br/ >10. Pregnancy <br/ >11. Inability to be positioned supine and flat for radiation planning and delivery <br/ >12. Inability to provide informed consent or lack of an authorized representative who can provide informed consent

2

Harshamitra Superspecialty Cancer Centre and Research Institute

40

90

India

Severe disease at enrollment

6: Severe disease at enrollment

61

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

Phase 2

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