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World’s First Experience of the Low-dose radionuclide inhalation therapy in the treatment of COVID-19-associated viral pneumonia: phase 1/2 clinical trial

Curr Radiopharm. 2023 Mar 7. doi: 10.2174/1874471016666230307113045. Online ahead of print.


OBJECTIVE: Previously, the 99mTc inhalation was used for pneumonia treatment that decreases inflammation and disease severity. We aimed to investigate the safety and effectiveness of carbon nanoparticles labeled with Technetium isotope (99mTc) in a form of ultradispersed aerosol in combination with standard COVID-19 therapy. The study was a randomized phase 1 and phase 2 clinical trial of low-dose radionuclide inhalation therapy for patients with COVID-19 related pneumonia.

METHOD: We enrolled 47 patients with confirmed COVID-19 infection and early laboratory signs of cytokine storm and randomized them into the Treatment and Control groups. We analyzed blood parameters reflecting the COVID-19 severity and inflammatory response.

RESULTS: Low-dose 99mTc-labeled inhalation showed a minimal accumulation of radionuclide in lungs in healthy volunteers. We observed no significant differences between the groups before treatment in WBC-count, D-dimer, CRP, Ferritin or LDH levels. We found that Ferritin and LDH levels significantly raised after the 7th day follow-up only in the Control group (p<0.0001 and p=0.0005, respectively), while mean values of the same indicators did not change in patients in the Treatment group after the radionuclide treatment. D-dimer values also lowered in the radionuclide treated group, however, this effect was not statistically significant. Furthermore, we evaluated a significant decrease in CD19+ cell counts in patients of the radionuclide-treated group.

CONCLUSION: Inhaled low-dose radionuclide therapy of 99mTc aerosol affects the major prognostic indicators of COVID-19-related pneumonia restraining inflammatory response. Overall, we identified no evidence of major adverse events in the group receiving radionuclide.

PMID:36880188 | DOI:10.2174/1874471016666230307113045

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