Trial Outcomes & Findings for NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19) (NCT NCT04442230)
NCT ID: NCT04442230
Last Updated: 2022-04-04
Results Overview
Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Day 1 to Day 14
Results posted on
2022-04-04
Participant Flow
Participant milestones
| Measure |
NasoVAX
Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension
|
Placebo
Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).
Placebo: Normal saline
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
Baseline characteristics by cohort
| Measure |
NasoVAX
n=23 Participants
Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension
|
Placebo
n=25 Participants
Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).
Placebo: Normal saline
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 14.05 • n=93 Participants
|
42.6 years
STANDARD_DEVIATION 14.98 • n=4 Participants
|
42.2 years
STANDARD_DEVIATION 14.39 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=93 Participants
|
25 participants
n=4 Participants
|
48 participants
n=27 Participants
|
|
Risk factors for severe COVID-19
Risk factors present
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Risk factors for severe COVID-19
No risk factors present
|
21 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Modified intent-to-treat population (all randomized patients who received any amount of study drug and had a Baseline and at least one post-baseline resting SpO2 measurement)
Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements
Outcome measures
| Measure |
NasoVAX
n=23 Participants
Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension
|
Placebo
n=25 Participants
Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).
Placebo: Normal saline
|
|---|---|---|
|
Percentage of Patients With Clinical Worsening
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 42Percentage of patients requiring hospitalization
Outcome measures
| Measure |
NasoVAX
n=23 Participants
Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension
|
Placebo
n=25 Participants
Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).
Placebo: Normal saline
|
|---|---|---|
|
Maximal Severity of COVID-19 After Treatment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 42All-cause mortality through Day 42
Outcome measures
| Measure |
NasoVAX
n=23 Participants
Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension
|
Placebo
n=25 Participants
Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).
Placebo: Normal saline
|
|---|---|---|
|
All-cause Mortality
|
0 Participants
|
0 Participants
|
Adverse Events
NasoVAX
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NasoVAX
n=23 participants at risk
Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).
NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension
|
Placebo
n=25 participants at risk
Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).
Placebo: Normal saline
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
39.1%
9/23 • Number of events 12 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
20.0%
5/25 • Number of events 7 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
26.1%
6/23 • Number of events 6 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
16.0%
4/25 • Number of events 4 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
21.7%
5/23 • Number of events 8 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
24.0%
6/25 • Number of events 8 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Number of events 1 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
8.0%
2/25 • Number of events 2 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
General disorders
Chills
|
34.8%
8/23 • Number of events 10 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
8.0%
2/25 • Number of events 2 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Gastrointestinal disorders
Fatigue
|
17.4%
4/23 • Number of events 4 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
12.0%
3/25 • Number of events 4 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
General disorders
Pyrexia
|
4.3%
1/23 • Number of events 1 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
0.00%
0/25 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Gastrointestinal disorders
Diarrhoea
|
30.4%
7/23 • Number of events 8 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
32.0%
8/25 • Number of events 9 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Gastrointestinal disorders
Nausea
|
21.7%
5/23 • Number of events 7 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
20.0%
5/25 • Number of events 5 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Nervous system disorders
Ageusia
|
0.00%
0/23 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
4.0%
1/25 • Number of events 1 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Nervous system disorders
Anosmia
|
0.00%
0/23 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
4.0%
1/25 • Number of events 1 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Number of events 3 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
12.0%
3/25 • Number of events 4 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Number of events 1 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
16.0%
4/25 • Number of events 4 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Infections and infestations
Folliculitis
|
0.00%
0/23 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
4.0%
1/25 • Number of events 1 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/23 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
4.0%
1/25 • Number of events 1 • 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
|
Additional Information
Sarah K. Browne, MD/Senior Director, Clinical Development
Altimmune, Inc.
Phone: 240-654-1450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All information provided regarding the study, as well as all information collected/documented during the course of the study, will be regarded as confidential. The Investigator agrees not to disclose such information in any way without prior written permission from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER