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NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04442230
Recruitment Status : Terminated (Enrollment)
First Posted : June 22, 2020
Results First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Coronavirus Infection
Interventions Biological: NasoVAX
Other: Placebo
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NasoVAX Placebo
Hide Arm/Group Description

Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).

NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension

Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).

Placebo: Normal saline
Period Title: Overall Study
Started 23 25
Completed 23 24
Not Completed 0 1
Arm/Group Title NasoVAX Placebo Total
Hide Arm/Group Description

Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).

NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension

Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).

Placebo: Normal saline

 Total of all reporting groups
Overall Number of Baseline Participants 23 25 48
Hide Baseline Analysis Population Description
Safety Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 25 participants 48 participants
41.8  (14.05) 42.6  (14.98) 42.2  (14.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
Female
9
  39.1%
9
  36.0%
18
  37.5%
Male
14
  60.9%
16
  64.0%
30
  62.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
Hispanic or Latino
21
  91.3%
22
  88.0%
43
  89.6%
Not Hispanic or Latino
2
   8.7%
3
  12.0%
5
  10.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.0%
1
   2.1%
White
23
 100.0%
24
  96.0%
47
  97.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 25 participants 48 participants
23 25 48
Risk factors for severe COVID-19  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
Risk factors present
2
   8.7%
1
   4.0%
3
   6.3%
No risk factors present
21
  91.3%
24
  96.0%
45
  93.8%
1.Primary Outcome
Title Percentage of Patients With Clinical Worsening
Hide Description Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements
Time Frame Day 1 to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title NasoVAX Placebo
Hide Arm/Group Description:

Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).

NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension

Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).

Placebo: Normal saline
Overall Number of Participants Analyzed 23 25
Measure Type: Count of Participants
Unit of Measure: Participants
3
  13.0%
2
   8.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NasoVAX, Placebo
Comments The p-values from significance tests were obtained at a one-sided significance level of 0.025.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6602
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Maximal Severity of COVID-19 After Treatment
Hide Description Percentage of patients requiring hospitalization
Time Frame Day 1 to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NasoVAX Placebo
Hide Arm/Group Description:

Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).

NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension

Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).

Placebo: Normal saline
Overall Number of Participants Analyzed 23 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title All-cause Mortality
Hide Description All-cause mortality through Day 42
Time Frame Day 1 to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NasoVAX Placebo
Hide Arm/Group Description:

Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).

NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension

Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).

Placebo: Normal saline
Overall Number of Participants Analyzed 23 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NasoVAX Placebo
Hide Arm/Group Description

Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).

NasoVAX: NasoVAX consists of replication-deficient adenovirus vectors in suspension

Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).

Placebo: Normal saline
All-Cause Mortality
NasoVAX Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
NasoVAX Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/23 (0.00%)      0/25 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
NasoVAX Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/23 (95.65%)      18/25 (72.00%)    
Gastrointestinal disorders     
Fatigue * 1  4/23 (17.39%)  4 3/25 (12.00%)  4
Diarrhoea * 1  7/23 (30.43%)  8 8/25 (32.00%)  9
Nausea * 1  5/23 (21.74%)  7 5/25 (20.00%)  5
General disorders     
Chills * 1  8/23 (34.78%)  10 2/25 (8.00%)  2
Pyrexia * 1  1/23 (4.35%)  1 0/25 (0.00%)  0
Infections and infestations     
Folliculitis * 1  0/23 (0.00%)  0 1/25 (4.00%)  1
Tracheobronchitis * 1  0/23 (0.00%)  0 1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders     
Myalgia * 1  1/23 (4.35%)  1 4/25 (16.00%)  4
Nervous system disorders     
Ageusia * 1  0/23 (0.00%)  0 1/25 (4.00%)  1
Anosmia * 1  0/23 (0.00%)  0 1/25 (4.00%)  1
Headache * 1  3/23 (13.04%)  3 3/25 (12.00%)  4
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  9/23 (39.13%)  12 5/25 (20.00%)  7
Oropharyngeal pain * 1  6/23 (26.09%)  6 4/25 (16.00%)  4
Nasal congestion * 1  5/23 (21.74%)  8 6/25 (24.00%)  8
Cough * 1  1/23 (4.35%)  1 2/25 (8.00%)  2
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sarah K. Browne, MD/Senior Director, Clinical Development
Organization: Altimmune, Inc.
Phone: 240-654-1450
EMail: sbrowne@altimmune.com
Layout table for additonal information
Responsible Party: Altimmune, Inc.
ClinicalTrials.gov Identifier: NCT04442230    
Other Study ID Numbers: ALT-601-201
First Submitted: June 17, 2020
First Posted: June 22, 2020
Results First Submitted: February 7, 2022
Results First Posted: April 4, 2022
Last Update Posted: April 4, 2022