COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56672

Dinakar Kootala

dinakarkmc1@gmail.com

2021-06-04

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Age 40 years or more and 2. Patients confirmed to have COVID-19 based on a positive RT_PCR for SARS CoV-2 and have been admitted to the hospital and 3. patients with any of a. PaO2/FiO2 between 100mmHg and 300mmHg or b. Respiratory rate >24per min or more, breathlessness or c. SpO2 <94% on room air and 4. Lung parenchymal involvement at baseline CT scan

1.Pregnancy and lactating mother <br/ >2.Prior thoracic radiation or chemotherapy with potential for pulmonary toxicity <br/ >3.Prior or planned treatment with interleukin inhibitors or TNF-α inhibitors <br/ >4.History of collagen vascular disease <br/ >5.Chronic lung diseases (Chronic obstructive lung disease, bronchial asthma), history of pulmonary tuberculosis <br/ >6.Inability to lie in supine on a flat couch with oxygen supplementation for radiation planning and delivery <br/ >7.Patients with PaO2/FiO2 <100 (severe ARDS) and/or on mechanical ventilation <br/ >8.Patients who are not willing to participate in the study <br/ >

2

Sri Venkateswara Institute of Medical Sciences

40

90

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

66

The primary outcome of the study will be a composite of progression to severe disease (PaO2/FiO2 ratio less than 100mmHg) any time within 28 days of enrolment or all cause mortality at 28 days. If progression to severe disease or all cause mortality could be prevented in the 28 days post-enrolment; the primary outcome will be considered as â??goodâ?? and if not it will be considered â??poorâ??.Timepoint: The primary outcome of the study will be a composite of progression to severe disease (PaO2/FiO2 ratio less than 100mmHg) any time within 28 days of enrolment or all cause mortality at 28 days. If progression to severe disease or all cause mortality could be prevented in the 28 days post-enrolment; the primary outcome will be considered as â??goodâ?? and if not it will be considered â??poorâ??.

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"}]