| CTRI Number |
CTRI/2021/05/033883 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
27/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Low dose Radiotherapy for COVID-19 using Linear accelerator |
|
Scientific Title of Study
|
Bilateral Whole lung Irradiation as a Novel treatment for COVID-19 induced acute respiratory distress syndrome(ARDS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vasireddy Abhinav |
| Designation |
Consultant Radiation Oncologist |
| Affiliation |
Surya Global Multi Speciality Hospital |
| Address |
Surya Global Multi Speciality Hospital
Madhavapatnam, Kakinada, Andhra Pradesh
Surya Global Multi Speciality Hospital
Department of Radiation Oncology,Ground floor,Room No 1010,Oncology Division
Madhavapatnam, Kakinada, Andhra Pradesh
533005
East Godavari
ANDHRA PRADESH
533005
India |
| Phone |
8247707221 |
| Fax |
|
| Email |
abhi6877@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BHPS Veerraju |
| Designation |
Chairman , Chief Surgical Oncologist |
| Affiliation |
Surya Global Multi Speciality Hospital |
| Address |
Surya Global Multi Speciality Hospital
Madhavapatnam, Kakinada, Andhra Pradesh
Surya Global Multi Speciality Hospital
Department of Surgical Oncology,Ground floor,Room No 1017,Oncology Division
Madhavapatnam, Kakinada, Andhra Pradesh
533005
East Godavari
ANDHRA PRADESH
533005
India |
| Phone |
9848124080 |
| Fax |
|
| Email |
drsuryaveerraju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sk khadari |
| Designation |
Manager |
| Affiliation |
Surya Global Multi Speciality Hospital |
| Address |
Surya Global Multi Speciality Hospital
Madhavapatnam, Kakinada, Andhra Pradesh
Surya Global Multi Speciality Hospital
Administrative Department
Third floor,Room No 4000
Madhavapatnam, Kakinada, Andhra Pradesh
533005
East Godavari
ANDHRA PRADESH
533005
India |
| Phone |
9676913786 |
| Fax |
|
| Email |
skkhadari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surya Global Multi Speciality Hospital |
|
|
Primary Sponsor
|
| Name |
Surya Global Multi Speciality Hospital |
| Address |
Madhavapatnam, Kakinada, Andhra Pradesh
533344 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vasireddy Abhinav |
Surya Global Multi Speciality Hospital |
Department of Radiation Oncology,Ground floor,Room No 1010,Oncology Division
Madhavapatnam, Kakinada, Andhra Pradesh
533005
East Godavari
ANDHRA PRADESH |
8247707221
abhi6877@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sury Global Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Dose External Beam Radiation therapy in
addition to standard
pharmacological therapy |
Low dose radiotherapy using a Linear accelerator to bilateral whole lungs as a single fraction treatment with a dose of 0.5 Gy
in addition to pharmacological therapy based on guidelines
devised by Ministry of Health and Family welfare, India
Dexamethasone 6mg IV Once
daily for 10 days (Alternative:
Methylprednisolone 80mg IV BD
for 10 days) Enoxiparin 60mgs/c Once Daily for 5 days (dose adjusted based on D-dimer levels), Remdesvir 200mg IV Once daily on day 1 followed by 100mg IV Once daily for next 4 days, further continuance based
on clinical response,
Convalescent plasma One or
two units (approximately
200-250ml per unit),
Tocilizumab 400mg IV as a
single dose (repeat dose in 12 to 24 hours if patient’s
condition has not improved),
Vitamin D 60,000U /week,
Vitamin C 1500 mg/day, Zinc,
Paracetamol, Anti-tussives,
Antibiotics, Oxygen
supplementation. Adjunctive
therapies : IV thiamine,IV
vitamin C, N acetyl cysteine Ulinastatin, Sepsivac
(mycobacterium w), high dose
statins. Salvage therapies :
Pulse therapy of steroids,
Cytosorb-hemoperfusion,
Pirfenidone,Alteplase. The
pharmacologic therapy is
individualized on a case by case basis |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients with RT-PCR proven COVID-19 with moderate to severe pneumonia with fewer than 14 days of symptom onset that
warranted hospitalization and currently receiving standard medication for COVID-19 at appropriate doses which would include,among others, antivirals, corticosteroids, or anti-IL-6 tocilizumab.and
2. moderate to severe dyspnoea, respiratory frequency equal to or greater than 30/min, oxygen saturation without supplemental O2
supply SpO2 94% or less, PaO2/FiO2 ratio or PaFiO2 ratio between 200 to 300 or SpO2/FiO2 ratio 315 or less if PaO2 is not available
and/or
3. laboratory abnormalities such as C-reactive protein>100 mg/L or D-dimer>1000 ng/ml or IL-6>50 IU or suspected cytokine release
syndrome |
|
| ExclusionCriteria |
| Details |
1. Patients on ventilators (invasive/non invasive)
2. Prior lobectomy or pneumonectomy
3. Prior thoracic radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment
4. Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radio sensitization within 14 days or 5 half-lives,
whichever is greater, of enrollment, e.g., bleomycin, gemcitabine
5. Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment
6. Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class 3 (or higher) congestive heart failure
7. History of bone marrow or solid organ transplantation
8. Known history of autoimmune collagen vascular disease, e.g.,scleroderma
9. Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia
10. Pregnancy
11. Inability to be positioned supine and flat for radiation planning and delivery
12. Inability to provide informed consent or lack of an authorized representative who can provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary end-point will be to evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in
patients with COVID-19 by improving the Spo2 levels 48-72h after treatment with respect to baseline pre-irradiation measurement |
6 hours,day 1,2,3,4,7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objectives include assessing the
safety of bilateral pulmonary LDRT using a
Linear acclerator,evaluating theimprovement of the radiological image, overall
mortality rate at 28 days after irradiation and
measuring the level of CRP, IL-6, D-dimer, Total
Lymphocyte count, Absolute neutrophil count and Neutrophil to Lymphocyte ratio and documenting the incidence of adverse events
and their grade if applicable |
Blood tests on Days 1,4,7,14,30
Baseline Chest X-ray and on Days 3,7
CT chest Baseline and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abhi6877@gmail.com].
- For how long will this data be available start date provided 24-07-2022 and end date provided 24-07-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The World Health Organization (WHO) has declared coronavirus disease 2019 (COVID-19) as pandemic in March 2020. Currently there is no vaccine or specific effective treatment for COVID-19. The major cause of death in COVID-19 is severe pneumonia leading to respiratory failure. Radiation in low doses (<100 cGy) has been known for its anti-inflammatory effect and therefore, low dose radiation therapy (LDRT) to lungs can potentially mitigate the severity of pneumonia and reduce mortality. We conducted a single arm trial to study the feasibility and clinical efficacy of LDRT to lungs in the management of patients with COVID-19. |