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Low Dose Radiotherapy in COVID-19 Pneumonia

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ClinicalTrials.gov Identifier: NCT04390412
Recruitment Status : Active, not recruiting
First Posted : May 15, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE May 13, 2020
First Posted Date  ICMJE May 15, 2020
Last Update Posted Date November 10, 2020
Actual Study Start Date  ICMJE May 4, 2020
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
  • Change from baseline blood oxygenation [ Time Frame: 28 days ]
    O2 saturation
  • Number of Hospital stay days [ Time Frame: 28 days ]
    Total days the patient is admitted to hospital
  • Number of ICU stay days [ Time Frame: 28 days ]
    Total days the patient is admitted to ICU
  • Number of intubation events [ Time Frame: 28 days ]
    Total number of intubations performed after the treatment
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
  • Change from baseline blood oxygenation [ Time Frame: 28 days ]
    PaO2 / FiO2
  • Number of Hospital stay days [ Time Frame: 28 days ]
    Total days the patient is admitted to hospital
  • Number of ICU stay days [ Time Frame: 28 days ]
    Total days the patient is admitted to ICU
  • Number of intubation events [ Time Frame: 28 days ]
    Total number of intubations performed after the treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
  • WBC [ Time Frame: 28 days ]
    Changes in WBC count if base-line is abnormal
  • Platelets [ Time Frame: 28 days ]
    Changes in Platelets count if base-line is abnormal
  • CRP [ Time Frame: Day 1 ]
    Changes in CRP serum level
  • CRP [ Time Frame: Day 2 ]
    Changes in CRP serum level
  • CRP [ Time Frame: Day 3 ]
    Changes in CRP serum level
  • CRP [ Time Frame: Day 4 ]
    Changes in CRP serum level
  • CRP [ Time Frame: Day 5 ]
    Changes in CRP serum level
  • IL-6 [ Time Frame: Day 1 ]
    Changes in IL-6 serum level
  • IL-6 [ Time Frame: Day 2 ]
    Changes in IL-6 serum level
  • IL-6 [ Time Frame: Day 3 ]
    Changes in IL-6 serum level
  • IL-6 [ Time Frame: Day 4 ]
    Changes in IL-6 serum level
  • IL-6 [ Time Frame: Day 5 ]
    Changes in IL-6 serum level
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
  • WBC [ Time Frame: 28 days ]
    Changes in WBC count
  • Platelets [ Time Frame: 28 days ]
    Changes in Platelets count
  • ESR [ Time Frame: 28 days ]
    Changes in ESR measurement
  • CRP [ Time Frame: 28 days ]
    Changes in CRP serum level
  • IL-6 [ Time Frame: Day 1 ]
    Changes in IL-6 serum level
  • IL-6 [ Time Frame: Day 4 ]
    Changes in IL-6 serum level
  • IL-6 [ Time Frame: Day 7 ]
    Changes in IL-6 serum level
  • IL-6 [ Time Frame: Day 14 ]
    Changes in IL-6 serum level
  • Chest CT scan [ Time Frame: Day 1 ]
    any radiological change in CT scan
  • Chest CT scan [ Time Frame: Day 7 ]
    any radiological change in CT scan
  • Chest CT scan [ Time Frame: Day 14 ]
    any radiological change in CT scan
  • Chest CT scan [ Time Frame: Day 28 ]
    any radiological change in CT scan
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Radiotherapy in COVID-19 Pneumonia
Official Title  ICMJE Assessment of Adding Low Dose Pulmonary Radiotherapy to the National Protocol of COVID-19 Management: A Pilot Trial
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.
Detailed Description

SARS-associated ARDS (acute respiratory distress syndrome) is the most fatal outcome of COVID-19 systemic infection. To overcome the uncontrolled inflammation leading to ARDS and respiratory failure, several drugs have been investigated in this situation with the most promising results coming from anti-inflammatory agents that directly or indirectly inhibit IL-6 and its counterparts of inflammation.

Low dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as IL-6.

In this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.Their diagnostic CT scan will be used to plan an AP/ PA radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. The patient will be referred for a fraction of 0.5 Gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. Should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 Gy to a maximum of 1 Gy in two fractions at least 72 hours apart. All the patients will also receive the standard national protocol of COVID-19 management.

A total of 5 patients will be enrolled in the RT arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase II clinical trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • COVID
  • SARS (Severe Acute Respiratory Syndrome)
Intervention  ICMJE Radiation: Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA treatment plan
Study Arms  ICMJE Experimental: Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA fashion
Intervention: Radiation: Low Dose Radiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 14, 2020)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04390412
Other Study ID Numbers  ICMJE 23568
IRCT20200509047366N1 ( Registry Identifier: Iranian Registry of Clinical Trials )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD will be shared after the completion of study to other researchers.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: After the completion of trial for one year.
Access Criteria: Verified researchers
Responsible Party Shahid Beheshti University of Medical Sciences
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ahmad Ameri, Prof. Shahid Beheshti University of Medical Sciences
Principal Investigator: Nazanin Rahnama, M.D. Shahid Beheshti University of Medical Sciences
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP