COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56762

DrKVelavan

kvels@rediffmail.com

2021-06-17

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1.Male or female with above 45 years of age, at the time of providing informed <br/ >consent. <br/ >2. Agreement to take effective contraception measures (including hormonal <br/ >contraception, barrier methods or abstinence) with his/her partner during the study <br/ >3. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or <br/ >oropharyngeal swabs (sample collected â?¤5 days prior to randomization) or CT <br/ >score CORADS III. <br/ >Note: If rapid antigen test has been performed and patient found positive then RT PCR will be performed prior to enrollment. <br/ >4. Has moderate to severe COVID-19 infection as defined as (with any one of the <br/ >following signs) <br/ >a. Respiratory rate â?¥ 24 and Ë?30/min, breathlessness <br/ >b. Oxygen saturation <93% without O2 support or patients requiring > <br/ >4L/Min of O2 <br/ >As defined by AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring <br/ >Group (Directorate General of Health Services) Ministry of Health & Family <br/ >Welfare, Government of India- clinical guidance for management of adult <br/ >COVID-19 patients, dated 22nd Apr 2021 <br/ >5. Is willing and able to take Radiation Therapy. <br/ >6. Raised CRP at the time of admission <br/ >7. Symptom onset less than 10 days or fewer. <br/ >8. CT Chest finding suggestive of pneumonic changes. <br/ >9. CT Severity index more than 8/25 (Moderate) <br/ >10. Willingness to comply with study instructions for its duration as indicated by <br/ >written informed consent from the patient/ LAR (in case LAR provides consent <br/ >initially, consent from patient to be obtained again as and when his/ her condition <br/ >stabilizes adequately). <br/ >11. Negative urine pregnancy test prior to beginning the therapy for female patients of <br/ >child-bearing potential only <br/ >

1. Pregnancy or lactation <br/ >2. History of allergy or hypersensitivity to any other treatment component based on <br/ >investigators assessment <br/ >3. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 <br/ >mL/min/1.73m2 <br/ >by the Modification of Diet in Renal Disease (MDRD) equation <br/ >4. Tested positive for Human immunodeficiency virus (HIV), Hepatitis B virus <br/ >(HBV) or Hepatitis C virus (HCV) infection <br/ >5. Abnormal laboratory findings at screening <br/ >ï?· Aspartate aminotransferase (AST) >3X upper limit of normal <br/ >ï?· Alanine aminotransferase (ALT) >3X upper limit of normal <br/ >ï?· Absolute neutrophil count <500/mm3 <br/ >or permicroliter <br/ >ï?· Platelet count <100,000 per microliter or /mm3 <br/ >6. Patients who received a platelet transfusion in the 5 days prior to enroll. <br/ >7. Has any condition for which, in the opinion of the investigator, participation <br/ >would not be in the best interest of the participant or that could prevent, limit, or <br/ >confound the protocol-specified assessments including but not limited to: <br/ >ï?· Participants who are not expected to survive longer than 48 hours at the time <br/ >of randomization, or <br/ >ï?· with patient on ventilator <br/ >ï?· Previous history of Thoracic RT. <br/ >ï?· History of hemodynamic intolerability <br/ >ï?· CT finding with fibrotic changes <br/ >ï?· Female patients with family history of breast cancer.

2

DrRSURESHKUMAR MBBSMDRT

45

60

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

1.Change from baseline oxygen saturation after 48 hours post irradiation; Day 3 and Day 7 post RT <br/ >2.Time interval taken to reduce Oxygen demand upto 50% from baseline if on O2 support. <br/ >3.Overall mortality rate at 28 days post radiation. <br/ >4. CT severity score change from baseline on Day 7 to one week of post RT. <br/ >5. Number of hospital stay days: <br/ > Total number of days admitted in hospital after Radiotherapy <br/ >6. Number of intubation events: <br/ > Total number of intubation events after RadiotherapyTimepoint: 28 (±2)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2/Phase 3

[{"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"}]