ow dose Radiation (LDRT) to Lungs to treat COVID- 19 patients

Phase 2

• Conditions: Health Condition 1: B342- Coronavirus infection, unspecifiedHealth Condition 2: J128- Other viral pneumonia

• Registration Number: CTRI/2021/05/033835
• Lead Sponsor: ViswaBharathi Medical College and General Hospital

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

Adult patients with RT-PCR proven COVID 19 disease with moderate to severe pneumonia with fewer than 14 days of symptom onset on standard medications for Covid-19 which included anti-viral drugs, steroids, anticoagulant drugs, and other supportive therapy drugs according to the ICMR and WHO guidelines.

Moderate to severe dyspnoea, Respiratory rate equal to or >24/min, Oxygen saturation 93% or less, PaO2/FiO2 ratio between 100-200.

CRP >100mg/l or D-Dimer >1000ng/ml or suspected cytokine release syndrome.

Criteria 1 and 2 are mandatory; 3 are optional.

Exclusion Criteria

1. Patients on ventilators (invasive/non invasive).

2. Patients with previous lobectomy or Pneumonectomy.

3. Patients who have undergone previous Radio Therapy.

4. Patients who have undergone previous chemotherapy; drug installation (gemci/bleomycin) or radio sensitization within 14days or 5 half lives.

5. Patients with prior cancer immunotherapy within 60 days of enrolment.

6. Patients with Severe pre existing heart disease- NYHA Class 3/ >; CHF.

7. Patients with History of bone marrow or solid organ transplant.

8. Patients with Known history of autoimmune collagen vascular disease (e.g. scleroderma)

9. Patients with Known hereditary syndrome with increased sensitivity to ionizing radiation .e.g. ataxia telangectasia or fanconi anaemia.

10. Patients with pregnancy

11. Patients with Inability to lie in supine posture for radiation treatment.

12. Patients with Inability to provide informed consent or lack of an authorized representative who can provide informed consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified