Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19

• Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04724538
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 3
• Actual Duration (Months): 5
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; Pneumonia, Viral	Radiation: 99mTc-pertechnetate aerosol; Drug: 99mTc-pertechnetate aerosol	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Inhalation Low Dose Radionuclide Therapy in Comprehensive Treatment of COVID-19 Viral Pneumonia
• Actual Study Start Date: Oct 15, 2020
• Actual Primary Completion Date: Feb 10, 2021
• Actual Study Completion Date: Mar 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy volunteers 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.	Radiation: 99mTc-pertechnetate aerosol; 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol
Experimental: Patient with COVID-19 pneumonia 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.	Drug: 99mTc-pertechnetate aerosol; 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol
No Intervention: Patient with COVID-19 pneumonia without intervention Blood tests at 1, 3 and 7 days.

Outcome Measures

Primary Outcome Measures

1. 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. [Days 1, 3 and 7 after inhalation]

   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.

2. 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. [Days 1, 3 and 7 after inhalation]

   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.

3. 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. [Days 1, 3 and 7 after inhalation]

   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.

4. 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. [Days 1, 3 and 7 after inhalation]

   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.

5. 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. [Days 1, 3 and 7 after inhalation]

   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.

6. 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. [Days 1, 3 and 7 after inhalation]

   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.

7. 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. [Days 1, 3 and 7 after inhalation]

   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.

8. 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. [Days 1, 3 and 7 after inhalation]

   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.

Secondary Outcome Measures

1. 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 [Days 1, 3 and 7 after inhalation]

   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.

2. 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 [Days 1, 3 and 7 after inhalation]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	P. Hertsen Moscow Oncology Research Institute	Moscow		Russian Federation	125284

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Dec 16, 2020

More Information

Publications

None provided.

• Responsible Party: Andrey Kaprin, general director of the National Medical Research Radiological Centre of the Ministry of Health of Russia, National Medical Research Radiological Centre of the Ministry of Health of Russia
• ClinicalTrials.gov Identifier: NCT04724538
• Other Study ID Numbers: RNT COVID-19
• First Posted: Jan 26, 2021
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrey Kaprin, general director of the National Medical Research Radiological Centre of the Ministry of Health of Russia, National Medical Research Radiological Centre of the Ministry of Health of Russia: COVID-19; viral pneumonia; radionuclide therapy
• Additional relevant MeSH terms: COVID-19; Pneumonia; Pneumonia, Viral; Sodium Pertechnetate Tc 99m

Study Results

Participant Flow

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Period Title: Overall Study
STARTED	11	14
COMPLETED	11	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention	Total
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.	Total of all reporting groups
Overall Participants	11	14	25
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 63.6%	6 42.9%	13 52%
>=65 years	4 36.4%	8 57.1%	12 48%
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	54.3	59.9	57.5
Sex: Female, Male (Count of Participants)
Female	4 36.4%	5 35.7%	9 36%
Male	7 63.6%	9 64.3%	16 64%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	11 100%	14 100%	25 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Russia	11 100%	14 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Count of white blood cells (WBC)

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
WBC - 1st day	11.2 (4.5)	9.8 (6.1)
WBC - 3rd day	9.7 (1.9)	8.7 (6.3)
WBC - 7th day	8.8 (3.6)	9.3 (2.1)

2. Primary Outcome

Title	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.
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Count of red blood cells (RBC)

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
RBC - 1st day	4.5 (0.6)	4.5 (0.4)
RBC - 3rd day	4.3 (0.4)	4.4 (0.5)
RBC - 7th day	4.2 (0.3)	4.4 (0.2)

3. Primary Outcome

Title	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.
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Hemoglobin count (Hb)

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
Hb - 1st day	140.5 (20.7)	132 (12.2)
Hb - 3rd day	137.5 (20.5)	130.6 (13.2)
Hb - 7th day	135.3 (16.4)	131 (14.4)

4. Primary Outcome

Title	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.
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Percentage of neutrophils (N)

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
Percentage of Neutrophils - 1st day	76.3 (9.98)	72.2 (10.4)
Percentage of Neutrophils - 3rd day	68.8 (10.7)	72.2 (12.3)
Percentage of Neutrophils - 7th day	68.4 (9.3)	71.5 (13.1)

5. Primary Outcome

Title	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.
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Absolute neutrophil count (ANC)

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
ANC - 1st day	8.8 (4.5)	7.4 (5.9)
ANC - 3rd day	6.8 (2.0)	6.6 (6.1)
ANC - 7th day	6.2 (3.4)	6.9 (2.9)

6. Primary Outcome

Title	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.
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Absolute Lymphocyte Count (ALC)

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
ALC - 1st day	1.6 (0.6)	1.6 (0.7)
ALC - 3rd day	2.1 (0.9)	1.4 (0.5)
ALC - 7th day	1.64 (0.5)	1.73 (0.3)

7. Primary Outcome

Title	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.
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Level of lactate in the blood

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
Lactate - 1st day	5 (1.9)	4.11 (1.5)
Lactate - 3rd day	4.4 (1.4)	4.6 (1.7)
Lactate - 7th day	4.28 (1.0)	4.81 (1.9)

8. Primary Outcome

Title	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.
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Level of D-dimer in blood

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
D-dimer - 1st day	1737 (1172)	1284 (1203)
D-dimer - 3rd day	843 (705)	685 (579)
D-dimer - 7th day	383 (255)	859 (693)

9. Secondary Outcome

Title	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
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Level of CD4+ T-cells in blood

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
CD4 - 1st day	761 (365)	614 (228)
CD4 - 3rd day	1100 (721)	832 (546)
CD4 - 7th day	845 (447)	718 (452)

10. Secondary Outcome

Title	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
Description	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.
Time Frame	Days 1, 3 and 7 after inhalation

Outcome Measure Data

Analysis Population Description

Level of NK-cells in blood

Arm/Group Title	Patient With COVID-19 Pneumonia	Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol	Blood tests at 1, 3 and 7 days.
Measure Participants	11	14
NK - 1st day	153 (83)	164 (72)
NK - 3rd day	188 (83)	149 (77)
NK - 7th day	219 (92)	181 (97)

Adverse Events

Time Frame	5 months
Arm/Group Title	Patient With COVID-19 Pneumonia		Patient With COVID-19 Pneumonia Without Intervention
Arm/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. 99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol		Blood tests at 1, 3 and 7 days.
All Cause Mortality
	Patient With COVID-19 Pneumonia		Patient With COVID-19 Pneumonia Without Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/14 (0%)
Serious Adverse Events
	Patient With COVID-19 Pneumonia		Patient With COVID-19 Pneumonia Without Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Patient With COVID-19 Pneumonia		Patient With COVID-19 Pneumonia Without Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.