A clinical trial to prove the benefit of low dose X-rays to lungs in treating COVID-19 disease

Phase 2

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2021/06/034001

Lead Sponsor: Sri Venkateswara Institute of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

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

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-Î± 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 <100 (severe ARDS) and/or on mechanical ventilation

8.Patients who are not willing to participate in the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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