NCT04724538

Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19

Inhalation Low Dose Radionuclide Therapy in Comprehensive Treatment of COVID-19 Viral Pneumonia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Coronavirus disease (COVID-19) is a pandemic of unprecedented proportions with an exponential increase in incidence. Airway epithelium infection caused by coronavirus (SARS-CoV-2) triggers a cascade of difficult-to-control reactions, a so-called "cytokine storm". In contrast to the previously used method of external beam radiation therapy for patients at high risk of a cytokine storm, in present study a different dose delivery mechanism through inhalation of 99mTc-labeled carbon ultrafine aerosol obtained from a TechnegasPlus generator is used. By utilizing anthropometric phantoms the dosimetric characteristics of the applied technique and obtained the coefficients of the transition from the count rate over the area of interest to the activity contained in this area (in kBq) were studied. By observing a group of healthy volunteers after inhalation of 99mTc-labeled carbon ultrafine aerosol, the accumulated dose in the human lungs under internal irradiation of 99mTc was determined. A novel technique has been developed and the possibility of using inhaled low-dose radionuclide therapy in the complex treatment of patients with COVID-19 - associated pneumonia has been studied. As a result, a significant improvement of hematological parameters in the group of patients after inhalation of 99mTc-labeled carbon ultrafine aerosol as compared to the control group is expected.

Conditions

• Covid19
• Pneumonia, Viral

Interventions

Type	Name	Description
RADIATION	99mTc-pertechnetate aerosol	99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol
DRUG	99mTc-pertechnetate aerosol	99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-02-10
• Completion: 2021-03-15
• First posted: 2021-01-26
• Last updated: 2021-07-07
• Results posted: 2021-07-07

Locations

1 site across 1 country: Russia