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 as per ICMR guidelines: Low dose radiation to a dose of 0.5Gy in single fraction with AP-PA fields using CT based planning on
India . Dexamethasone 6mg IV Once daily for 10 days (Alternative: Methylprednisolone 80mg IV BD for 10 days) Enoxiparin 60mgs/c Once Daily for 5 days (dose adjusted based on D-dimer levels), Remdesvir
India. Dexamethasone 6mg IV Once daily for 10 days (Alternative: Methylprednisolone 80mg IV BD for 10 days) Enoxiparin 60mgs/c Once Daily for 5 days (dose adjusted based on D-dimer levels), Remdesvir
Sponsors
Sri Venkateswara Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1.Pregnancy and lactating mother 2.Prior thoracic radiation or chemotherapy with potential for pulmonary toxicity 3.Prior or planned treatment with interleukin inhibitors or TNF-α inhibitors 4.History of collagen vascular disease 5.Chronic lung diseases (Chronic obstructive lung disease, bronchial asthma), history of pulmonary tuberculosis 6.Inability to lie in supine on a flat couch with oxygen supplementation for radiation planning and delivery 7.Patients with PaO2/FiO2 8.Patients who are not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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??. | — |
Secondary
| Measure | Time frame |
|---|---|
| change in oxygen requirement after LDRT measured as variation of fraction of inspired oxygenTimepoint: days 3,7,14 and 28;post-enrolment duration of respiratory supportTimepoint: until day 28 or discharge, whichever earlier;proportion of participants requiring invasive or non-invasive ventilation post enrolmentTimepoint: until day 28 or discharge, whichever earlier;proportion of participants with radiological response assessed by change in CT severity scoreTimepoint: Compare baseline (day 0) and day 7;time to symptom resolution, measured as the proportion of participants showing resolution of symptoms of fever, shortness of breathTimepoint: days 3, 7, 14 and 28;total duration of respiratory support during hospital admissionTimepoint: at time of discharge alive or death | — |
Countries
India
Contacts
Public ContactDinakar Kootala
Sri Venkateswara Institute of Medical Sciences (SVIMS)
Outcome results
None listed