Trial Outcomes & Findings for Evaluation of Safety and Efficiency of Method of Exosome Inhalation in SARS-CoV-2 Associated Pneumonia. (NCT NCT04491240)
NCT ID: NCT04491240
Last Updated: 2020-11-04
Results Overview
Safety assessment such as adverse events will be registered. Adverse events will be monitored during all trial
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
30 days after clinic discharge
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
EXO-1
Participants (n=10) in this group will receive standard therapy and exosomes of the first type.
EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.
|
EXO-2
Participants (n=10) in this group will receive standard therapy and exosomes of the second type.
EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.
|
Placebo
Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.
Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EXO-1
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the first type.
EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.
|
EXO-2
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the second type.
EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.
|
Placebo
n=10 Participants
Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.
Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
47.9 years
n=10 Participants
|
52.5 years
n=10 Participants
|
53.3 years
n=10 Participants
|
51.23 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
19 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 30 days after clinic dischargeSafety assessment such as adverse events will be registered. Adverse events will be monitored during all trial
Outcome measures
| Measure |
EXO-1
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the first type.
EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.
|
EXO-2
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the second type.
EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.
|
Placebo
n=10 Participants
Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.
Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
|
|---|---|---|---|
|
Number of Participants With Non-serious and Serious Adverse Events During Trial
Number of participants with serious adverse events during trial
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious and Serious Adverse Events During Trial
Number of participants with non-serious adverse events during trial
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: after each inhalation during 10 daysSafety assessments such as adverse events during the inhalation procedures will be registered.
Outcome measures
| Measure |
EXO-1
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the first type.
EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.
|
EXO-2
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the second type.
EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.
|
Placebo
n=10 Participants
Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.
Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
|
|---|---|---|---|
|
Number of Participants With Non-serious and Serious Adverse During Inhalation Procedure
Temperature increase
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious and Serious Adverse During Inhalation Procedure
Bronchospasm
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious and Serious Adverse During Inhalation Procedure
allergic reaction in the form of swelling Quincke, rash, seizures, etc.
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Non-serious and Serious Adverse During Inhalation Procedure
Other
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from first inhalation until discharge from the clinic, up to 30 daysMeasure and compare time to clinical recovery compared to placebo. Time to clinical recovery calculated by the number of days the patient has hospitalized.
Outcome measures
| Measure |
EXO-1
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the first type.
EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.
|
EXO-2
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the second type.
EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.
|
Placebo
n=10 Participants
Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.
Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
|
|---|---|---|---|
|
Time to Clinical Recovery (TTCR)
|
13.8 days
Standard Deviation 1.55
|
14.8 days
Standard Deviation 2.35
|
14.1 days
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: 10 days during inhalationThe concentration of SpO2 by Pulse oximetry device during procedures in the groups. The measure was done before and after each inhalation (total 4 measures per day). The intraday SpO2 data of all patients in groups was calculated as Median with Inter-Quartile Range and presented in the table by days.
Outcome measures
| Measure |
EXO-1
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the first type.
EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.
|
EXO-2
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the second type.
EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.
|
Placebo
n=10 Participants
Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.
Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
|
|---|---|---|---|
|
SpO2 Concentration
Day 1
|
93.8 O2 concentration in percent
Interval 93.5 to 94.0
|
94.5 O2 concentration in percent
Interval 93.6 to 94.9
|
94 O2 concentration in percent
Interval 94.0 to 94.9
|
|
SpO2 Concentration
Day 2
|
94.8 O2 concentration in percent
Interval 94.0 to 95.0
|
95.3 O2 concentration in percent
Interval 94.1 to 95.9
|
96 O2 concentration in percent
Interval 95.6 to 96.0
|
|
SpO2 Concentration
Day 3
|
95.3 O2 concentration in percent
Interval 95.0 to 95.5
|
95.5 O2 concentration in percent
Interval 94.6 to 95.9
|
96 O2 concentration in percent
Interval 95.1 to 96.4
|
|
SpO2 Concentration
Day 4
|
95.5 O2 concentration in percent
Interval 95.1 to 95.9
|
96 O2 concentration in percent
Interval 95.6 to 96.9
|
96.5 O2 concentration in percent
Interval 96.0 to 96.9
|
|
SpO2 Concentration
Day 5
|
96 O2 concentration in percent
Interval 95.3 to 96.4
|
96.5 O2 concentration in percent
Interval 95.6 to 96.9
|
97.3 O2 concentration in percent
Interval 96.6 to 97.5
|
|
SpO2 Concentration
Day 6
|
96 O2 concentration in percent
Interval 96.0 to 96.9
|
97 O2 concentration in percent
Interval 96.3 to 97.0
|
97 O2 concentration in percent
Interval 97.0 to 97.5
|
|
SpO2 Concentration
Day 7
|
96.8 O2 concentration in percent
Interval 96.5 to 97.5
|
97.5 O2 concentration in percent
Interval 97.0 to 97.5
|
97.5 O2 concentration in percent
Interval 97.0 to 97.9
|
|
SpO2 Concentration
Day 8
|
97.3 O2 concentration in percent
Interval 97.0 to 98.0
|
97.3 O2 concentration in percent
Interval 97.0 to 97.9
|
98.3 O2 concentration in percent
Interval 97.1 to 98.9
|
|
SpO2 Concentration
Day 9
|
97.3 O2 concentration in percent
Interval 97.0 to 98.0
|
97.8 O2 concentration in percent
Interval 97.0 to 99.0
|
98.5 O2 concentration in percent
Interval 98.1 to 98.9
|
|
SpO2 Concentration
Day 10
|
97.8 O2 concentration in percent
Interval 97.1 to 98.8
|
98.5 O2 concentration in percent
Interval 97.6 to 99.0
|
98.8 O2 concentration in percent
Interval 98.0 to 99.0
|
SECONDARY outcome
Timeframe: At the begining of inhalation (day 1) and on next day of last inhalation (day 11)Blood biochemistry C reactive protein level in serum.
Outcome measures
| Measure |
EXO-1
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the first type.
EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.
|
EXO-2
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the second type.
EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.
|
Placebo
n=10 Participants
Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.
Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
|
|---|---|---|---|
|
C-reactive Protein
Day 1
|
78.3 mg/L
Interval 4.3 to 299.0
|
75.4 mg/L
Interval 5.7 to 137.0
|
61.5 mg/L
Interval 11.6 to 147.0
|
|
C-reactive Protein
Day 11
|
5.04 mg/L
Interval 0.5 to 12.5
|
5.83 mg/L
Interval 0.4 to 32.1
|
8.29 mg/L
Interval 0.4 to 41.1
|
SECONDARY outcome
Timeframe: At the beginning of inhalation (day 1) and on next day of last inhalation (day 11)Lactic Acid Dehydrogenase (LDH) level in serum
Outcome measures
| Measure |
EXO-1
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the first type.
EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.
|
EXO-2
n=10 Participants
Participants (n=10) in this group will receive standard therapy and exosomes of the second type.
EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.
|
Placebo
n=10 Participants
Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.
Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
|
|---|---|---|---|
|
Lactic Acid Dehydrogenase (LDH)
at Day 11
|
441 U/L
Interval 280.0 to 740.0
|
365 U/L
Interval 30.4 to 648.0
|
430 U/L
Interval 306.0 to 686.0
|
|
Lactic Acid Dehydrogenase (LDH)
at Day 1
|
773 U/L
Interval 383.0 to 1285.0
|
732 U/L
Interval 380.0 to 1867.0
|
669 U/L
Interval 333.0 to 1260.0
|
Adverse Events
EXO-1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EXO-2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EXO-1
n=10 participants at risk
Participants (n=10) in this group will receive standard therapy and exosomes of the first type.
EXO 1 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the first type.
|
EXO-2
n=10 participants at risk
Participants (n=10) in this group will receive standard therapy and exosomes of the second type.
EXO 2 inhalation: Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10\^10 of nanoparticles (exosomes) of the second type.
|
Placebo
n=10 participants at risk
Participants (n=10) in this group will receive standard therapy and inhalation placebo solution.
Placebo inhalation: Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Temperature increase
|
0.00%
0/10 • During medical procedures and 1-month post-discharge from the clinic.
Collection of information on unwanted reactions to inhalation after each inhalation, e.g. 1) temperature increase, 2) allergic reaction in the form of Quincke's disease, rash, seizures, etc.; 3) bronchospasm for inhalation.
|
0.00%
0/10 • During medical procedures and 1-month post-discharge from the clinic.
Collection of information on unwanted reactions to inhalation after each inhalation, e.g. 1) temperature increase, 2) allergic reaction in the form of Quincke's disease, rash, seizures, etc.; 3) bronchospasm for inhalation.
|
0.00%
0/10 • During medical procedures and 1-month post-discharge from the clinic.
Collection of information on unwanted reactions to inhalation after each inhalation, e.g. 1) temperature increase, 2) allergic reaction in the form of Quincke's disease, rash, seizures, etc.; 3) bronchospasm for inhalation.
|
|
Immune system disorders
Allergic reactions
|
0.00%
0/10 • During medical procedures and 1-month post-discharge from the clinic.
Collection of information on unwanted reactions to inhalation after each inhalation, e.g. 1) temperature increase, 2) allergic reaction in the form of Quincke's disease, rash, seizures, etc.; 3) bronchospasm for inhalation.
|
0.00%
0/10 • During medical procedures and 1-month post-discharge from the clinic.
Collection of information on unwanted reactions to inhalation after each inhalation, e.g. 1) temperature increase, 2) allergic reaction in the form of Quincke's disease, rash, seizures, etc.; 3) bronchospasm for inhalation.
|
0.00%
0/10 • During medical procedures and 1-month post-discharge from the clinic.
Collection of information on unwanted reactions to inhalation after each inhalation, e.g. 1) temperature increase, 2) allergic reaction in the form of Quincke's disease, rash, seizures, etc.; 3) bronchospasm for inhalation.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/10 • During medical procedures and 1-month post-discharge from the clinic.
Collection of information on unwanted reactions to inhalation after each inhalation, e.g. 1) temperature increase, 2) allergic reaction in the form of Quincke's disease, rash, seizures, etc.; 3) bronchospasm for inhalation.
|
0.00%
0/10 • During medical procedures and 1-month post-discharge from the clinic.
Collection of information on unwanted reactions to inhalation after each inhalation, e.g. 1) temperature increase, 2) allergic reaction in the form of Quincke's disease, rash, seizures, etc.; 3) bronchospasm for inhalation.
|
0.00%
0/10 • During medical procedures and 1-month post-discharge from the clinic.
Collection of information on unwanted reactions to inhalation after each inhalation, e.g. 1) temperature increase, 2) allergic reaction in the form of Quincke's disease, rash, seizures, etc.; 3) bronchospasm for inhalation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place