Low-dose radiation therapy for COVID-19 pneumonia: a pilot study

  1. Daya Nand Sharma
  2. Randeep Guleria
  3. Naveet Wig
  4. Anant Mohan
  5. Goura Rath
  6. Vellaiyan Subramani
  7. Sushma Bhatnagar
  8. Supriya Mallick
  9. Aman Sharma
  10. Pritee Patil
  11. Karan Madan
  12. Manish Soneja
  13. Sanjay Thulkar
  14. Angel Singh
  15. Sheetal Singh

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Abstract

The World Health Organization (WHO) has declared coronavirus disease 2019 (COVID-19) as pandemic in March 2020. Currently there is no specific effective treatment for COVID-19. The major cause of death in COVID-19 is severe pneumonia leading to respiratory failure. Radiation in low doses (<100 cGy) has been known for its anti-inflammatory effect and therefore, low dose radiation therapy (LDRT) to lungs can potentially mitigate the severity of pneumonia and reduce mortality. We conducted a pilot trial to study the feasibility and clinical efficacy of LDRT to lungs in the management of patients with COVID-19.

Methods:

From June to Aug 2020, we enrolled 10 patients with COVID-19 having moderate to severe risk disease [National Early Warning Score (NEWS) of ≥5]. Patients were treated as per the standard COVID-19 management guidelines along with LDRT to both lungs with a dose of 70cGy in single fraction. Response assessment was done based on the clinical parameters using the NEWS.

Results:

All patients completed the prescribed treatment. Nine patients had complete clinical recovery mostly within a period ranging from 3 to 7 days. One patient, who was a known hypertensive, showed clinical deterioration and died 24 days after LDRT. No patients showed the signs of acute radiation toxicity.

Conclusion:

The results of our pilot study suggest that LDRT is feasible in COVID-19 patients having moderate to severe disease. Its clinical efficacy may be tested by conducting randomized controlled trials.

Advances in knowledge:

LDRT has shown promising results in COVID-19 pneumonia and should be researched further through randomized controlled trials.

Article activity feed

  1. Version published to 10.1259/bjr.20210187
  2. ScreenIT

    SciScore for 10.1101/2020.11.16.20231514: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was initiated after approval by Institute Ethics committee (Ref. No. IEC-465/22.05.2020, RP-01/2020).
    Consent: Eligible patients (as per inclusion criteria) were enrolled in the study after obtaining their consent.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Our study has several limitations including small sample size and response assessment without radiological or laboratory investigations. We wanted to keep the study design simple and convenient for smooth conduction considering the fear of radiation exposure amongst the patient population and also the panic in radiation therapy team which is primarily a non-COVID team. There are several ongoing trials (ClinicalTrials.gov Identifier: NCT04427566, NCT04572412, NCT04377477, NCT04493294 and NCT04393948) with primary outcome assessment based on clinical parameters. (21) In conclusion, the results of our pilot study suggest that LDRT is feasible and clinically effective in COVID-19 patients having moderate to severe disease. Based on the encouraging results of two recently published trials (14, 15) and our study, it is justified to conduct large randomized controlled trials to establish the clinical efficacy of LDRT to reduce the COVID-19 mortality.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04394793Active, not recruitingLow Dose Radiation Therapy for Covid-19 Pneumonia
    NCT04427566RecruitingLow Dose Whole Lung Radiation Therapy for Patients With COVI…
    NCT04572412RecruitingLow Dose Lung Radiotherapy to Treat COVID-19 Pneumonia
    NCT04377477RecruitingCOVID-19 Pneumonitis Low Dose Lung Radiotherapy (COLOR-19)
    NCT04493294Not yet recruitingLow Dose Whole Lung Radiotherapy for Older Patients With COV…
    NCT04393948RecruitingLung Irradiation for COVID-19 Pneumonia

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

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  3. Version published to 10.1101/2020.11.16.20231514v1 on medRxiv