NCT04394793

Brief Summary

Radiotherapy in low doses (30 to 100 cGy) was a popular treatment of viral pneumonias until 1940s. Low dose radiation therapy (LDRT) could possibly reduce the inflammation and prevent the cytokine storm thus mitigating the severity of pneumonitis. This is a single arm study designed to assess the feasibility and clinical efficacy of low dose radiation therapy (70 cGy in single fraction) in the patients with COVID-19 pneumonia. A total of 10 eligible patients (as per inclusion criteria) will be recruited and response will be assessed based on the symptomatic improvement or deterioration by using the National Early Warning Score (NEWS). The NEWS score will be recorded on baseline and then on Day 3, Day 7 and Day 14.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

June 13, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

May 17, 2020

Last Update Submit

August 30, 2020

Conditions

COVID-19Pneumonia

Keywords

Covid-19pneumonialow dose radiation therapy

Outcome Measures

Primary Outcomes (5)

  • Symptomatic improvement by National Early warning score (NEWS)

    NEWS score

    Day 3

  • Symptomatic improvement by National Early warning score (NEWS)

    NEWS score

    Day 7

  • Symptomatic improvement by National Early warning score (NEWS)

    NEWS score

    Day 14

  • Length of hospital stay

    Days

    30 days or date of death whichever is earlier

  • Number of ICU admissions or deaths

    Number of patients

    30 days

Study Arms (1)

Study Arm

EXPERIMENTAL
Radiation: Low dose radiation therapy

Interventions

Low dose radiation therapyRADIATION

Patient will be treated with a dose of 70 cGy in one fraction radiation therapy in addition to standard therapy

Study Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed cases of Covid-19 (by RT-PCR).
  • Age \>18 years.
  • Patients with National Early Warning Score (NEWS) score ≥ 5.
  • Consent

You may not qualify if:

  • Patients on mechanical ventilatory support.
  • Hemodynamically unstable patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences, New Delhi

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (3)

  • Kirkby C, Mackenzie M. Is low dose radiation therapy a potential treatment for COVID-19 pneumonia? Radiother Oncol. 2020 Jun;147:221. doi: 10.1016/j.radonc.2020.04.004. Epub 2020 Apr 6. No abstract available.

    PMID: 32342871BACKGROUND

  • Calabrese EJ, Dhawan G. How radiotherapy was historically used to treat pneumonia: could it be useful today? Yale J Biol Med. 2013 Dec 13;86(4):555-70.

    PMID: 24348219BACKGROUND

  • Sbiti-Rohr D, Kutz A, Christ-Crain M, Thomann R, Zimmerli W, Hoess C, Henzen C, Mueller B, Schuetz P; ProHOSP Study Group. The National Early Warning Score (NEWS) for outcome prediction in emergency department patients with community-acquired pneumonia: results from a 6-year prospective cohort study. BMJ Open. 2016 Sep 28;6(9):e011021. doi: 10.1136/bmjopen-2015-011021.

    PMID: 27683509BACKGROUND

MeSH Terms

Conditions

COVID-19Pneumonia

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Daya Nand Sharma, MD

    AIIMS, New Delhi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 19, 2020

Study Start

June 13, 2020

Primary Completion

August 27, 2020

Study Completion

September 1, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)