Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Test product- LDRT (Administered as 50 â?? 100 cGy): The study will be conducted with 100 patients. These 100 patients will be assessed for
safety and efficacy outcomes till Day 28 pos
Sponsors
DrRSURESHKUMAR MBBSMDRT
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female with above 45 years of age, at the time of providing informed consent. 2. Agreement to take effective contraception measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study 3. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected score CORADS III. Note: If rapid antigen test has been performed and patient found positive then RT PCR will be performed prior to enrollment. 4. Has moderate to severe COVID-19 infection as defined as (with any one of the following signs) a. Respiratory rate >= 24 and Ë?30/min, breathlessness b. Oxygen saturation 4L/Min of O2 As defined by AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group (Directorate General of Health Services) Ministry of Health & Family Welfare, Government of India- clinical guidance for management of adult COVID-19 patients, dated 22nd Apr 2021 5. Is willing and able to take Radiation Therapy. 6. Raised CRP at the time of admission 7. Symptom onset less than 10 days or fewer. 8. CT Chest finding suggestive of pneumonic changes. 9. CT Severity index more than 8/25 (Moderate) 10. Willingness to comply with study instructions for its duration as indicated by written informed consent from the patient/ LAR (in case LAR provides consent initially, consent from patient to be obtained again as and when his/ her condition stabilizes adequately). 11. Negative urine pregnancy test prior to beginning the therapy for female patients of child-bearing potential only
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. History of allergy or hypersensitivity to any other treatment component based on investigators assessment 3. Patients on dialysis or having reduced glomerular filtration rate (eGFR) mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation 4. Tested positive for Human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection 5. Abnormal laboratory findings at screening ï?· Aspartate aminotransferase (AST) >3X upper limit of normal ï?· Alanine aminotransferase (ALT) >3X upper limit of normal ï?· Absolute neutrophil count or permicroliter ï?· Platelet count 6. Patients who received a platelet transfusion in the 5 days prior to enroll. 7. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: ï?· Participants who are not expected to survive longer than 48 hours at the time of randomization, or ï?· with patient on ventilator ï?· Previous history of Thoracic RT. ï?· History of hemodynamic intolerability ï?· CT finding with fibrotic changes ï?· Female patients with family history of breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change from baseline oxygen saturation after 48 hours post irradiation, Day 3 and Day 7 post RT 2.Time interval taken to reduce Oxygen demand upto 50% from baseline if on O2 support. 3.Overall mortality rate at 28 days post radiation. 4. CT severity score change from baseline on Day 7 to one week of post RT. 5. Number of hospital stay days: Total number of days admitted in hospital after Radiotherapy 6. Number of intubation events: Total number of intubation events after RadiotherapyTimepoint: 28 (±2) | — |
Secondary
| Measure | Time frame |
|---|---|
| To document and characterize the factors implicating the change in treatment patterns during Covid-19 pandemic 2. To ascertain the effect of Covid-19 pandemic with short term outcomes 3. WBC changes from baseline 4. Change in CRP level from baseline at Days 1,3 and 7 post radiotherapy 5. Changes in Interleukin 6 level from baseline at days 1 and 7 post radiotherapyTimepoint: 28 (±2) | — |
Countries
India
Contacts
Public ContactDrKVelavan
Erode Cancer Centre Private Limited
Outcome results
None listed