Status:
UNKNOWN
Low-Dose Radiation Therapy to Lungs in Moderate COVID-19 Pneumonitis: A Case-Control Pilot Study
Lead Sponsor:
Mahatma Gandhi Institute of Medical Sciences
Conditions:
COVID-19
Pneumonia
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This pilot case-control study at Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, India is designed to evaluate the use of low dose radiotherapy (LDRT) in patients with moderate COVID-1...
Detailed Description
One of the primary attributes to the mortality in coronavirus disease -19 (COVID-19) is acute respiratory distress syndrome (ARDS) induced by severe acute respiratory syndrome coronavirus type 2 (SARS...
Eligibility Criteria
Inclusion
- Reverse transcription polymerase chain reaction (RT-PCR) / Rapid Ag test positive
- Signed informed consent
- Age ≥ 50 yrs
- Respiratory rate : 25 - 30/min, breathless AND/OR
- Oxygen saturation by pulse oximetry (SpO2) in 90 - 93% on room air (readings taken after 5 mins of stopping oxygen supplementation)
- Rising levels of quantitative-CRP and/or D-Dimer and/or Ferritin in 2 consecutive samples taken 24 hours apart
Exclusion
- Patient who have received vaccination for COVID-19 (single / both doses of any approved vaccine)
- Hemodynamic instability in shock and/or systolic BP \< 90mm Hg
- Septicemia
- Disseminated intravascular coagulation
- Requiring ventilation
- Unable to lie down supine
- Severe acute respiratory distress with Fraction of inspired oxygen (FiO2) \< 100mm Hg
- Cardiac defibrillator/pacemaker in situ
- Lymphocyte count \< 1 x 106/ml
- Pregnancy and/or lactating mothers
- HIV and/or HbsAg positive patients
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04904783
Start Date
June 1 2021
End Date
December 31 2021
Last Update
July 27 2021
Active Locations (2)
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1
Mahatma Gandhi Institute of Medical Sciences,
Sevāgrām, Maharashtra, India, 442102
2
Mahatma Gandhi Institute of Medical Sciences
Sevāgrām, Maharashtra, India, 442102