Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724538
• Other study ID #: RNT COVID-19
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 15, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: July 2021
• Source: National Medical Research Radiological Centre of the Ministry of Health of Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 15, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Pneumonia
• Pneumonia, Viral

Intervention

Radiation:
• 99mTc-pertechnetate aerosol
99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol

Drug:
• 99mTc-pertechnetate aerosol
99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol

Locations

Country	Name	City	State
Russian Federation	P. Hertsen Moscow Oncology Research Institute	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Research Radiological Centre of the Ministry of Health of Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation
Primary	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.	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation
Primary	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.	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation
Primary	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.	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation
Primary	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.	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation
Primary	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.	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation
Primary	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.	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation
Primary	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.	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation
Secondary	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	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation
Secondary	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	Patients with COVID-19 viral pneumonia were observed for safety after administration of 99mTc-pertechnetate aerosol inhalation, and followed up at 1, 3, 7 days after inhalation. Patients did blood test to observe for abnormalities in clinical parameters and compare to baseline results as assessed by CTCAE v5.0. These tests were also performed in patients with COVID-19 viral pneumonia receiving standard treatment. The results were compared between the two groups.	Days 1, 3 and 7 after inhalation