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Low Dose Radiation Therapy for Covid-19 Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04394793
Recruitment Status : Active, not recruiting
First Posted : May 19, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Daya Nand Sharma, All India Institute of Medical Sciences, New Delhi

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.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Radiation: Low dose radiation therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Radiation Therapy for Covid-19 Pneumonia: A Pilot Study
Actual Study Start Date : June 13, 2020
Actual Primary Completion Date : August 27, 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Study Arm Radiation: Low dose radiation therapy
Patient will be treated with a dose of 70 cGy in one fraction radiation therapy in addition to standard therapy




Primary Outcome Measures :
  1. Symptomatic improvement by National Early warning score (NEWS) [ Time Frame: Day 3 ]
    NEWS score

  2. Symptomatic improvement by National Early warning score (NEWS) [ Time Frame: Day 7 ]
    NEWS score

  3. Symptomatic improvement by National Early warning score (NEWS) [ Time Frame: Day 14 ]
    NEWS score

  4. Length of hospital stay [ Time Frame: 30 days or date of death whichever is earlier ]
    Days

  5. Number of ICU admissions or deaths [ Time Frame: 30 days ]
    Number of patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients on mechanical ventilatory support.
  2. Hemodynamically unstable patients

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): NCT04394793


Locations
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India
All India Institute of Medical Sciences, New Delhi
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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Principal Investigator: Daya Nand Sharma, MD AIIMS, New Delhi
Publications:
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Responsible Party: Daya Nand Sharma, Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT04394793    
Other Study ID Numbers: COVID-AIIMS
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Daya Nand Sharma, All India Institute of Medical Sciences, New Delhi:
Covid-19
pneumonia
low dose radiation therapy
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections