COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56430

Murugesh linga perumal

murugeshlp@yahoo.co.in

2021-06-01

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Patients with confirmed diagnosis of SARS-Cov2 infection by RT-PCR on nasopharyngeal swab and / or bronchoalveolar lavage (BAL) <br/ >2.moderate to severe dyspnoea, respiratory frequency â?¥ 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 <br/ >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. <br/ >4.first and second criteria are mandatory and third is optional <br/ >

1.Prior lobectomy or pneumonectomy <br/ >2.contraindication to radiation (Example: Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia) <br/ >3.previous history of radiation to thoracic organs <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.Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class â?¥ 3 congestive heart failure <br/ >6.Pregnancy.

2

Guru Hospitals

18

100

India

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

106

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

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

[{"arm_notes": "", "treatment_id": 746, "treatment_name": "Low dose radiation therapy", "treatment_type": "Radiation therapy", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]