NCT04427566: VENTED

Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise

Recruiting now Phase 2 Last updated 15 March 2021

What this trial tests

Phase 2 trial testing Radiation therapy in COVID-19 in 24 participants. Currently enrolling.

Timeline

23 July 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Ohio State University Comprehensive Cancer Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	23 July 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Radiation therapy — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Ohio State University Comprehensive Cancer Center

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Low doses of radiation in the form of chest X-rays have been used to treat people with pneumonia. This treatment was found to be effective by reducing inflammation and with minimal side effects. However, it was an expensive treatment and was eventually replaced with less costly treatments such as antibiotics. Radiation has also been shown in some animal experiments to reduce some types of inflammation.

Some patients diagnosed with COVID-19 pneumonia will experience worsening disease, which can become very serious, requiring the use of a ventilator. This is caused by inflammation in the lung from the virus and the immune system. For this study, the x-ray given is called radiation therapy. Radiation therapy uses high-energy X-ray beams from a large machine to target the lungs and reduce inflammation. Usually, it is given at much higher doses to treat cancers.

The purpose of this study is to find out if adding a single treatment of low-dose x-rays to the lungs might reduce the amount of inflammation in the lungs from a COVID-19 infection, which could help a patient to breathe without use of a ventilator.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Low-Dose Whole-Lung Irradiation for COVID-19 Pneumonia: Short Course Results.
   Ameri A, Rahnama N, Bozorgmehr R, Mokhtari M, et al · · 2020 · cited 50× · PMID 32707264 · DOI 10.1016/j.ijrobp.2020.07.026
2. Low-Dose Radiation Therapy (LDRT) for COVID-19: Benefits or Risks?
   Prasanna PG, Woloschak GE, DiCarlo AL, Buchsbaum JC, et al · · 2020 · cited 37× · PMID 33045077 · DOI 10.1667/rade-20-00211.1
3. Low-dose radiation therapy for COVID-19 pneumonia: a pilot study.
   Sharma DN, Guleria R, Wig N, Mohan A, et al · · 2021 · cited 36× · PMID 34545760 · DOI 10.1259/bjr.20210187
4. The risk of induced cancer and ischemic heart disease following low dose lung irradiation for COVID-19: estimation based on a virtual case.
   Arruda GV, Weber RRDS, Bruno AC, Pavoni JF. · · 2021 · cited 14× · PMID 33164596 · DOI 10.1080/09553002.2021.1846818
5. The Role of Ionizing Radiation for Diagnosis and Treatment against COVID-19: Evidence and Considerations.
   Chalkia M, Arkoudis NA, Maragkoudakis E, Rallis S, et al · · 2022 · cited 7× · PMID 35159277 · DOI 10.3390/cells11030467
6. COVID-19: The Disease, the Immunological Challenges, the Treatment with Pharmaceuticals and Low-Dose Ionizing Radiation.
   Yu J, Azzam EI, Jadhav AB, Wang Y. · · 2021 · cited 5× · PMID 34571861 · DOI 10.3390/cells10092212
7. Low-dose radiation therapy for coronavirus disease-2019 pneumonia: Is it time to look beyond apprehensions?
   Pandey BN. · · 2020 · cited 5× · PMID 33381234 · DOI 10.4103/atm.atm_433_20
8. Multi-phase failure modes and effects analysis for low dose bilateral whole lung irradiation of COVID-19 positive patients requiring respiratory ventilation.
   Swanson AE, DiCostanzo DJ, Gupta N, Hintenlang K, et al · · 2024 · cited 2× · PMID 38194600 · DOI 10.1002/acm2.14261