Trial Outcomes & Findings for Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19 (NCT NCT04724538)
NCT ID: NCT04724538
Last Updated: 2021-07-07
Results Overview
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.
COMPLETED
PHASE1/PHASE2
25 participants
Days 1, 3 and 7 after inhalation
2021-07-07
Participant Flow
Participant milestones
| Measure |
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.
99mTc-pertechnetate aerosol: 99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol
|
Patient With COVID-19 Pneumonia Without Intervention
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
14
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19
Baseline characteristics by cohort
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
54.3 Years
n=5 Participants
|
59.9 Years
n=7 Participants
|
57.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Count of white blood cells (WBC)
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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.
WBC - 1st day
|
11.2 x 1000 cells/microL
Standard Deviation 4.5
|
9.8 x 1000 cells/microL
Standard Deviation 6.1
|
|
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.
WBC - 3rd day
|
9.7 x 1000 cells/microL
Standard Deviation 1.9
|
8.7 x 1000 cells/microL
Standard Deviation 6.3
|
|
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.
WBC - 7th day
|
8.8 x 1000 cells/microL
Standard Deviation 3.6
|
9.3 x 1000 cells/microL
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Count of red blood cells (RBC)
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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.
RBC - 1st day
|
4.5 x million cells/microL
Standard Deviation 0.6
|
4.5 x million cells/microL
Standard Deviation 0.4
|
|
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.
RBC - 3rd day
|
4.3 x million cells/microL
Standard Deviation 0.4
|
4.4 x million cells/microL
Standard Deviation 0.5
|
|
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.
RBC - 7th day
|
4.2 x million cells/microL
Standard Deviation 0.3
|
4.4 x million cells/microL
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Hemoglobin count (Hb)
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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.
Hb - 1st day
|
140.5 gm/L
Standard Deviation 20.7
|
132 gm/L
Standard Deviation 12.2
|
|
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.
Hb - 3rd day
|
137.5 gm/L
Standard Deviation 20.5
|
130.6 gm/L
Standard Deviation 13.2
|
|
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.
Hb - 7th day
|
135.3 gm/L
Standard Deviation 16.4
|
131 gm/L
Standard Deviation 14.4
|
PRIMARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Percentage of neutrophils (N)
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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.
Percentage of Neutrophils - 1st day
|
76.3 percentage
Standard Deviation 9.98
|
72.2 percentage
Standard Deviation 10.4
|
|
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.
Percentage of Neutrophils - 3rd day
|
68.8 percentage
Standard Deviation 10.7
|
72.2 percentage
Standard Deviation 12.3
|
|
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.
Percentage of Neutrophils - 7th day
|
68.4 percentage
Standard Deviation 9.3
|
71.5 percentage
Standard Deviation 13.1
|
PRIMARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Absolute neutrophil count (ANC)
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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.
ANC - 1st day
|
8.8 x 1000 cells/microL
Standard Deviation 4.5
|
7.4 x 1000 cells/microL
Standard Deviation 5.9
|
|
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.
ANC - 3rd day
|
6.8 x 1000 cells/microL
Standard Deviation 2.0
|
6.6 x 1000 cells/microL
Standard Deviation 6.1
|
|
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.
ANC - 7th day
|
6.2 x 1000 cells/microL
Standard Deviation 3.4
|
6.9 x 1000 cells/microL
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Absolute Lymphocyte Count (ALC)
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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.
ALC - 1st day
|
1.6 x 1000 cells/microL
Standard Deviation 0.6
|
1.6 x 1000 cells/microL
Standard Deviation 0.7
|
|
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.
ALC - 3rd day
|
2.1 x 1000 cells/microL
Standard Deviation 0.9
|
1.4 x 1000 cells/microL
Standard Deviation 0.5
|
|
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.
ALC - 7th day
|
1.64 x 1000 cells/microL
Standard Deviation 0.5
|
1.73 x 1000 cells/microL
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Level of lactate in the blood
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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.
Lactate - 1st day
|
5 mmol/L
Standard Deviation 1.9
|
4.11 mmol/L
Standard Deviation 1.5
|
|
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.
Lactate - 3rd day
|
4.4 mmol/L
Standard Deviation 1.4
|
4.6 mmol/L
Standard Deviation 1.7
|
|
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.
Lactate - 7th day
|
4.28 mmol/L
Standard Deviation 1.0
|
4.81 mmol/L
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Level of D-dimer in blood
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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.
D-dimer - 1st day
|
1737 ngm/mL
Standard Deviation 1172
|
1284 ngm/mL
Standard Deviation 1203
|
|
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.
D-dimer - 3rd day
|
843 ngm/mL
Standard Deviation 705
|
685 ngm/mL
Standard Deviation 579
|
|
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.
D-dimer - 7th day
|
383 ngm/mL
Standard Deviation 255
|
859 ngm/mL
Standard Deviation 693
|
SECONDARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Level of CD4+ T-cells in blood
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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
CD4 - 1st day
|
761 x 1000 cells/microL
Standard Deviation 365
|
614 x 1000 cells/microL
Standard Deviation 228
|
|
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
CD4 - 3rd day
|
1100 x 1000 cells/microL
Standard Deviation 721
|
832 x 1000 cells/microL
Standard Deviation 546
|
|
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
CD4 - 7th day
|
845 x 1000 cells/microL
Standard Deviation 447
|
718 x 1000 cells/microL
Standard Deviation 452
|
SECONDARY outcome
Timeframe: Days 1, 3 and 7 after inhalationPopulation: Level of NK-cells in blood
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.
Outcome measures
| Measure |
Patient With COVID-19 Pneumonia
n=11 Participants
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
|
Patient With COVID-19 Pneumonia Without Intervention
n=14 Participants
Blood tests at 1, 3 and 7 days.
|
|---|---|---|
|
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
NK - 1st day
|
153 x 1000 cells/microL
Standard Deviation 83
|
164 x 1000 cells/microL
Standard Deviation 72
|
|
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
NK - 3rd day
|
188 x 1000 cells/microL
Standard Deviation 83
|
149 x 1000 cells/microL
Standard Deviation 77
|
|
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
NK - 7th day
|
219 x 1000 cells/microL
Standard Deviation 92
|
181 x 1000 cells/microL
Standard Deviation 97
|
Adverse Events
Patient With COVID-19 Pneumonia
Patient With COVID-19 Pneumonia Without Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mariia Sedova, MD
P. Hertsen Moscow Oncology Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place