Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19

National Medical Research Radiological Centre of the Ministry of Health of Russia

Status and phase: Completed; Phase 2; Phase 1

Conditions: Covid19; Pneumonia, Viral

Treatments: Drug: 99mTc-pertechnetate aerosol

Study type: Interventional

Funder types: Other

Identifiers

NCT04724538

RNT COVID-19

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Positive SARS-Cov-2 polymerase chain reaction (PCR)
2. CT confirmed pneumonia
3. Men and non-pregnant women ≥ 18 y/o with early laboratory signs of cytokine storm
4. Men and non-pregnant women <65 y/o and/or with early laboratory signs of cytokine storm
5. Informed consent obtained for participation

Exclusion criteria

1. Age ≤ 18
2. Severe course of COVID-19
3. Pregnant or breast-feeding females
4. Severe concomitant pathology
5. Previous and/or present treatment of oncology disease (e.g. immunotherapy)
6. Autoimmune diseases, severe cardiac disease, bone marrow and/or visceral transplantation
7. Surgical treatment and/or radiotherapy of chest pathology
8. Treatment with specific antiviral and anticytokine agents a day before inhalation procedure
9. Absence of informed consent obtained for participation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Healthy volunteers

Experimental group

Description:

CT-scans for exclusion of pneumonia. Accumulated absorbed dose calculation of volunteers' lungs after inhalation of 99mTc-pertechnetate aerosol from commercial gas generator which was loaded by 833 MBq of 99mTc-pertechnetate.

Patient with COVID-19 pneumonia

Experimental group

Description:

Inhalation of 99mTc-pertechnetate aerosol from commercial gas generator which was loaded by 4165 MBq of 99mTc-pertechnetate. CT scans a day before, 7 and 14 days after inhalation procedure. Blood tests a day before, 1, 3 and 7 days after inhalation procedure.

Treatment:

Drug: 99mTc-pertechnetate aerosol

Drug: 99mTc-pertechnetate aerosol

Patient with COVID-19 pneumonia without intervention

No Intervention group

Description:

Blood tests at 1, 3 and 7 days.