Health Condition 1: B342- Coronavirus infection, unspecified Health Condition 2: J128- Other viral pneumonia
Conditions
Interventions
Intervention1: Role of one time Low dose radiation(LDRT) to whole lung in the treatment of COVID19 disease.: Low dose radiation using a linear accelerator to bilateral whole lungs as a single fraction
Prophylactic UFH or LMWH(enoxaparin 0.5mg/kg per day SC).
Remedesvir 200mg IV day 1 f/b 100mg IV OD for next 4days and Tocilizumab 4-6mg/kg (individualised based on disease severity).
Adjunctive thera
Prophylactic UFH or LMWH(enoxaparin 0.5mg/kg per day SC).
Remedesvir 200mg IV day 1
Sponsors
ViswaBharathi Medical College and General Hospital
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point will be to evaluate the efficacy of low dose pulmonary radiation as an adjunctive treatment in viral Pneumonitis of COVID 19 patients in terms of improvement in the PaO2-FiO2 at least by 20% measured 72 hrs after radiation treatment till 7 days.Timepoint: 6th hourly follow up to 72 hours followed by daily assessment for 7 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives include improvement on radiological imaging,Improvement in inflammatory blood parameters- CRP; improved oxygen saturation; decrease in hospital stay and mortality at 28 days.Timepoint: Blood tests on days 1,4,7,14,28. Pre-radiation Chest X- Ray followed by post radiation X-ray Chest on day 3 and day 7. | — |
Countries
India
Contacts
Public ContactDr S Muneeruddin Ahmed
Viswabharathi medical college
Outcome results
None listed