A clinical trial study to evaluate the safety and efficacy of low dose radiation therapy for the treatment of Covid-19 disease

Phase 2

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

• Registration Number: CTRI/2021/06/034284
• Lead Sponsor: DrRSURESHKUMAR MBBSMDRT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <=5 days prior to randomization) or CT

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 <93% without O2 support or patients requiring >

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

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) <30

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 <500/mm3

or permicroliter

ï?· Platelet count <100,000 per microliter or /mm3

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified