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Low Dose Radiotherapy in COVID-19 Pneumonia

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ClinicalTrials.gov Identifier: NCT04390412
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
COVID SARS (Severe Acute Respiratory Syndrome) Radiation: Low Dose Radiotherapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of Adding Low Dose Pulmonary Radiotherapy to the National Protocol of COVID-19 Management: A Pilot Trial
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA fashion
Radiation: Low Dose Radiotherapy
0.5 Gy radiation to both lungs in an AP/PA treatment plan




Primary Outcome Measures :
  1. Change from baseline blood oxygenation [ Time Frame: 28 days ]
    PaO2 / FiO2

  2. Number of Hospital stay days [ Time Frame: 28 days ]
    Total days the patient is admitted to hospital

  3. Number of ICU stay days [ Time Frame: 28 days ]
    Total days the patient is admitted to ICU

  4. Number of intubation events [ Time Frame: 28 days ]
    Total number of intubations performed after the treatment


Secondary Outcome Measures :
  1. WBC [ Time Frame: 28 days ]
    Changes in WBC count

  2. Platelets [ Time Frame: 28 days ]
    Changes in Platelets count

  3. ESR [ Time Frame: 28 days ]
    Changes in ESR measurement

  4. CRP [ Time Frame: 28 days ]
    Changes in CRP serum level

  5. IL-6 [ Time Frame: Day 1 ]
    Changes in IL-6 serum level

  6. IL-6 [ Time Frame: Day 4 ]
    Changes in IL-6 serum level

  7. IL-6 [ Time Frame: Day 7 ]
    Changes in IL-6 serum level

  8. IL-6 [ Time Frame: Day 14 ]
    Changes in IL-6 serum level

  9. Chest CT scan [ Time Frame: Day 1 ]
    any radiological change in CT scan

  10. Chest CT scan [ Time Frame: Day 7 ]
    any radiological change in CT scan

  11. Chest CT scan [ Time Frame: Day 14 ]
    any radiological change in CT scan

  12. Chest CT scan [ Time Frame: Day 28 ]
    any radiological change in CT scan



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed COVID-19 diagnosis ( PCR or serologic)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390412


Contacts
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Contact: Nazanin Rahnama, M.D. 00989123157370 nazanin.rahnama@sbmu.ac.ir
Contact: Ahmad Ameri, Prof. 00989123088087 a_ameri@sbmu.ac.ir

Locations
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Iran, Islamic Republic of
Imam Hossein Hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Imam Hossein Hospital    00982173430 ext 2614    info@ehmc.ir   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
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Study Chair: Ahmad Ameri, Prof. Shahid Beheshti University of Medical Sciences
Principal Investigator: Nazanin Rahnama, M.D. Shahid Beheshti University of Medical Sciences
Publications:
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Responsible Party: Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04390412    
Other Study ID Numbers: 23568
IRCT20200509047366N1 ( Registry Identifier: Iranian Registry of Clinical Trials )
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared after the completion of study to other researchers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After the completion of trial for one year.
Access Criteria: Verified researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shahid Beheshti University of Medical Sciences:
Low Dose Lung Radiotherapy
COVID-19
anti-inflammatory
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases