NCT04390412

Brief Summary

Moderate to severe cases of SARS-associated ARDS based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 Gy whole lung radiation.

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
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2020

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

May 4, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 10, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

May 13, 2020

Last Update Submit

November 6, 2020

Conditions

COVIDSARS (Severe Acute Respiratory Syndrome)

Keywords

Low Dose Lung RadiotherapyCOVID-19anti-inflammatory

Outcome Measures

Primary Outcomes (4)

  • Change from baseline blood oxygenation

    O2 saturation

    28 days

  • Number of Hospital stay days

    Total days the patient is admitted to hospital

    28 days

  • Number of ICU stay days

    Total days the patient is admitted to ICU

    28 days

  • Number of intubation events

    Total number of intubations performed after the treatment

    28 days

Secondary Outcomes (12)

  • WBC

    28 days

  • Platelets

    28 days

  • CRP

    Day 1

  • CRP

    Day 2

  • CRP

    Day 3

  • +7 more secondary outcomes

Study Arms (1)

Low Dose Radiotherapy

EXPERIMENTAL

0.5 Gy radiation to both lungs in an AP/PA fashion

Radiation: Low Dose Radiotherapy

Interventions

Low Dose RadiotherapyRADIATION

0.5 Gy radiation to both lungs in an AP/PA treatment plan

Low Dose Radiotherapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed COVID-19 diagnosis ( PCR or serologic or radiographic)
  • Presence of pulmonary involvement ( defined by P/F ratio or NIV need)
  • Less than 3 days since the onset of ARDS
  • Age \> 60 years
  • ↑ IL-6 ( if available)
  • ↑ CRP

You may not qualify if:

  • Lack of informed consent
  • Inability to transfer to the radiation unit
  • Hemodynamic instability
  • Septic shock and organ dysfunction
  • Severe ARDS P/F ratio ≤ 100 mmHg
  • History of cardiac failure
  • Contraindications to radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Hossein Hospital

Tehran, Iran

Location

Related Publications (6)

  • 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

  • Large M, Hehlgans S, Reichert S, Gaipl US, Fournier C, Rodel C, Weiss C, Rodel F. Study of the anti-inflammatory effects of low-dose radiation: The contribution of biphasic regulation of the antioxidative system in endothelial cells. Strahlenther Onkol. 2015 Sep;191(9):742-9. doi: 10.1007/s00066-015-0848-9. Epub 2015 Jun 8.

    PMID: 26051282BACKGROUND

  • Clayton B. Hess, MD, MPH, and Mohammad K. Khan, MD, PhD, "Low dose chest radiation for COVID-19 patients" Winship Emory News post, April 27, 2020

    BACKGROUND

  • 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

  • Kefayat A, Ghahremani F. Low dose radiation therapy for COVID-19 pneumonia: A double-edged sword. Radiother Oncol. 2020 Jun;147:224-225. doi: 10.1016/j.radonc.2020.04.026. Epub 2020 Apr 20. No abstract available.

    PMID: 32342874BACKGROUND

  • Stefano M Magrini, Prof et al. COVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19). ClinicalTrials.gov Identifier: NCT04377477

    BACKGROUND

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ahmad Ameri, Prof.

    Shahid Beheshti University of Medical Sciences

    STUDY CHAIR

  • Nazanin Rahnama, M.D.

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 15, 2020

Study Start

May 4, 2020

Primary Completion

August 30, 2020

Study Completion

December 1, 2020

Last Updated

November 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

IPD will be shared after the completion of study to other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After the completion of trial for one year.
Access Criteria
Verified researchers

Locations

IR(1)