NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of NasoVAX in preventing worsening of symptoms and hospitalization in patients with early COVID-19.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
After being informed about the study and potential risks, all patient volunteers that have given written informed consent will undergo screening to determine eligibility for study entry. If the patient qualifies for the study, they will be randomized in a double-blind manner in a 1:1 ratio to receive NasoVAX or placebo. On the same day of qualifying into the study, the patient will be administered the investigational drug (either NasoVAX or placebo).
The patient will return home for the remainder of the study. During this period, the patient will be monitored remotely by the study center for clinical status. The patient will also be contacted by study center personnel by telephone to ask about use of any medications and changes in health including information about any hospitalization.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: NasoVAX Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment). |
Biological: NasoVAX
NasoVAX consists of replication-deficient adenovirus vectors in suspension
|
Placebo Comparator: Placebo Participants will receive a single intranasal dose of placebo on Day 1 (enrollment). |
Other: Placebo
Normal saline
|
Outcome Measures
Primary Outcome Measures
- Percentage of Patients With Clinical Worsening [Day 1 to Day 14]
Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements
Secondary Outcome Measures
- Maximal Severity of COVID-19 After Treatment [Day 1 to Day 42]
Percentage of patients requiring hospitalization
- All-cause Mortality [Day 1 to Day 42]
All-cause mortality through Day 42
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able and willing to provide informed consent (Patients themselves must provide written informed consent before the performance of any study-related procedures, and surrogate consent by family members, designated legal representatives or caregivers will not be permitted).
-
Men and women 18 years of age and older
-
Early COVID-19, defined as one or more symptom(s) of fever (oral temperature ≥ 100.4 degrees F), cough, or shortness of breath, onset of these symptoms within 72 hours of screening, and confirmation of SARS-CoV-2 infection by a polymerase chain reaction (PCR)-based or rapid antigen diagnostic.
-
Resting SpO2 ≥ 96.0% on room air on two successive measurements
-
For women of childbearing potential (women who are not permanently sterile [documented hysterectomy, bilateral tubal ligation, salpingectomy, or oophorectomy] or postmenopausal [12 months with no menses without an alternative medical cause])
-
Negative urine pregnancy test at Screening
-
Willingness to practice a highly effective method of contraception that includes, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, licensed hormonal methods, intrauterine device, or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the last dose of study drug
-
For men with sexual partners of childbearing potential, willingness to practice a highly effective method of contraception, as defined above, for 45 days after the last dose of study drug
-
Ability and willingness to comply with all aspects of the study, including reliable internet access, through the entire study period
Exclusion Criteria:
-
Pregnant or lactating women or planning to conceive a child during the next 3 months
-
Resting respiratory rate >20 breaths/min on room air or resting pulse rate ≥ 125 beats per minute
-
A rapidly worsening course that in the opinion of the Investigator or treating medical practitioner would lead to hospitalization within the next 24-48 hours
-
Any chronic pulmonary disease, including chronic obstructive pulmonary disease and asthma, or other respiratory diseases that could exacerbate independent of COVID-19
-
The following risk factors for severe COVID-19 (Cohorts 1 and 2 only) (Centers for Disease Control 2020), which based on ongoing review of efficacy and safety data, the DMC may remove part or all of these risk factors if preliminary data show no signal for adverse or paradoxical effects:
-
Severe obesity, defined as body mass index ≥ 40 kg/m2
-
History of:
-
Severe cardiovascular disease, including but not limited to congestive heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, or pulmonary hypertension
-
Diabetes mellitus
-
Chronic or current vaping or cigarette smoking
-
Chronic kidney disease requiring dialysis
-
Chronic liver disease, including but not limited to chronic viral hepatitis, non-alcoholic steatohepatitis, or cirrhosis of any cause
-
Hemoglobin disorder, including sickle cell disease and thalassemia
-
History of Bell's Palsy
-
Nasal conditions that might affect the suitability of intranasal medication, such as a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or nasal surgery other than cosmetic rhinoplasty.
-
Use of hydroxychloroquine within the past 4 months, chloroquine with the past 9 months, or other investigational agents for COVID-19 within the past 30 days
-
History of conditions associated with immunocompromise, including but not limited to poorly controlled HIV, or treatments known to affect the immune system, including but not limited to oral or intravenous corticosteroids, alkylating drugs, antimetabolites, cytotoxic drugs, radiation, immune-modulating biologics (including interleukin [IL]-6, IL-12, Janus kinase inhibitors or antagonists), and cancer treatments, within 30 days of Screening, or anticipated use within 6 months following participation in this study
-
Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a patient's ability to give informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Miami Dade Medical Research Institute | Miami | Florida | United States | 33176 |
2 | Infinite Clinical Trials | Morrow | Georgia | United States | 30260 |
3 | Cedar Crosse Research Center | Chicago | Illinois | United States | 60607 |
4 | Carolina Institute for Clinical Research | Fayetteville | North Carolina | United States | 28303 |
5 | Next Level Urgent Care | Houston | Texas | United States | 77057 |
6 | Centex Studies | Houston | Texas | United States | 77058 |
7 | Centex Studies | McAllen | Texas | United States | 78504 |
Sponsors and Collaborators
- Altimmune, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- ALT-601-201
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | NasoVAX | Placebo |
---|---|---|
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 |
Baseline Characteristics
Arm/Group Title | NasoVAX | Placebo | Total |
---|---|---|---|
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 Participants | 23 | 25 | 48 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
41.8
(14.05)
|
42.6
(14.98)
|
42.2
(14.39)
|
Sex: Female, Male (Count of Participants) | |||
Female |
9
39.1%
|
9
36%
|
18
37.5%
|
Male |
14
60.9%
|
16
64%
|
30
62.5%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
21
91.3%
|
22
88%
|
43
89.6%
|
Not Hispanic or Latino |
2
8.7%
|
3
12%
|
5
10.4%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
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%
|
1
4%
|
1
2.1%
|
White |
23
100%
|
24
96%
|
47
97.9%
|
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] | |||
United States |
23
100%
|
25
100%
|
48
100%
|
Risk factors for severe COVID-19 (Count of Participants) | |||
Risk factors present |
2
8.7%
|
1
4%
|
3
6.3%
|
No risk factors present |
21
91.3%
|
24
96%
|
45
93.8%
|
Outcome Measures
Title | Percentage of Patients With Clinical Worsening |
---|---|
Description | Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements |
Time Frame | Day 1 to Day 14 |
Outcome Measure Data
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 |
---|---|---|
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 |
Measure Participants | 23 | 25 |
Count of Participants [Participants] |
3
13%
|
2
8%
|
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 | ||
Statistical Test of Hypothesis | p-Value | 0.6602 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Maximal Severity of COVID-19 After Treatment |
---|---|
Description | Percentage of patients requiring hospitalization |
Time Frame | Day 1 to Day 42 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | NasoVAX | Placebo |
---|---|---|
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 |
Measure Participants | 23 | 25 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | All-cause Mortality |
---|---|
Description | All-cause mortality through Day 42 |
Time Frame | Day 1 to Day 42 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | NasoVAX | Placebo |
---|---|---|
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 |
Measure Participants | 23 | 25 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Adverse Events
Time Frame | 28 days, or up to 42 days for subject hospitalized for COVID-19 at Day 28 | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | NasoVAX | Placebo | ||
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 (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/23 (0%) | 0/25 (0%) | ||
Serious Adverse Events |
||||
NasoVAX | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/23 (0%) | 0/25 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
NasoVAX | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 22/23 (95.7%) | 18/25 (72%) | ||
Gastrointestinal disorders | ||||
Fatigue | 4/23 (17.4%) | 4 | 3/25 (12%) | 4 |
Diarrhoea | 7/23 (30.4%) | 8 | 8/25 (32%) | 9 |
Nausea | 5/23 (21.7%) | 7 | 5/25 (20%) | 5 |
General disorders | ||||
Chills | 8/23 (34.8%) | 10 | 2/25 (8%) | 2 |
Pyrexia | 1/23 (4.3%) | 1 | 0/25 (0%) | 0 |
Infections and infestations | ||||
Folliculitis | 0/23 (0%) | 0 | 1/25 (4%) | 1 |
Tracheobronchitis | 0/23 (0%) | 0 | 1/25 (4%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
Myalgia | 1/23 (4.3%) | 1 | 4/25 (16%) | 4 |
Nervous system disorders | ||||
Ageusia | 0/23 (0%) | 0 | 1/25 (4%) | 1 |
Anosmia | 0/23 (0%) | 0 | 1/25 (4%) | 1 |
Headache | 3/23 (13%) | 3 | 3/25 (12%) | 4 |
Respiratory, thoracic and mediastinal disorders | ||||
Dyspnoea | 9/23 (39.1%) | 12 | 5/25 (20%) | 7 |
Oropharyngeal pain | 6/23 (26.1%) | 6 | 4/25 (16%) | 4 |
Nasal congestion | 5/23 (21.7%) | 8 | 6/25 (24%) | 8 |
Cough | 1/23 (4.3%) | 1 | 2/25 (8%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Name/Title | Sarah K. Browne, MD/Senior Director, Clinical Development |
---|---|
Organization | Altimmune, Inc. |
Phone | 240-654-1450 |
sbrowne@altimmune.com |
- ALT-601-201