CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
99mTc-pertechnetate aerosol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04724538
NCT04724538Phase 2Completed

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

National Medical Research Radiological Centre of the Ministry of Health of Russia·interventional·Posted Jan 26, 2021·Updated Jul 7, 2021

In Brief

A Phase 2 clinical trial evaluating 99mTc-pertechnetate aerosol for Covid19 and Pneumonia, Viral. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRussia
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 26, 2021
Enrollment StartOct 15, 2020
Primary CompletionFeb 10, 2021
Study CompletionMar 15, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.4 years ago

Interventions

99mTc-pertechnetate aerosolradiation

99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol

99mTc-pertechnetate aerosoldrug

99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol