Clinical trial NCT04724538: Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19
Official title: Inhalation Low Dose Radionuclide Therapy in Comprehensive Treatment of COVID-19 Viral Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Covid19
Pneumonia, Viral
Keywords: COVID-19
viral pneumonia
radionuclide therapy
Lead sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Count of White Blood Cells (WBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
timeFrame: Days 1, 3 and 7 after inhalation
measure: Count of Red Blood Cells (RBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
timeFrame: Days 1, 3 and 7 after inhalation
measure: Hemoglobin Count (Hb) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
timeFrame: Days 1, 3 and 7 after inhalation
measure: Percentage of Neutrophils (N) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
timeFrame: Days 1, 3 and 7 after inhalation
measure: Absolute Neutrophil Count (ANC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
timeFrame: Days 1, 3 and 7 after inhalation
measure: Absolute Lymphocyte Count (ALC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
timeFrame: Days 1, 3 and 7 after inhalation
measure: Level of Lactate in the Blood After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
timeFrame: Days 1, 3 and 7 after inhalation
measure: Level of D-dimer in Blood After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.
timeFrame: Days 1, 3 and 7 after inhalation
Secondary outcomes:
measure: Level of CD4+ T-cells in Blood After 99mTc-pertechnetate Aerosol Inhalation for Evaluation of Cellular Immune Response After This Procedure in Patients With COVID-19 Viral Pneumonia
timeFrame: Days 1, 3 and 7 after inhalation
measure: Level of NK-cells in Blood After 99mTc-pertechnetate Aerosol Inhalation for Evaluation of Cellular Immune Response After This Procedure in Patients With COVID-19 Viral Pneumonia
timeFrame: Days 1, 3 and 7 after inhalation
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: P. Hertsen Moscow Oncology Research Institute
Study officials:
References: