Coronavirus InfectionPhase 2NCT04442230
NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
A Phase 2 study testing NasoVAX in people with Coronavirus Infection, run by Altimmune, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- NasoVAX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Oct 2020to 15 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cedar Crosse Research Center
Chicago, Illinois, 60607
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28303
Next Level Urgent Care
Houston, Texas, 77057
Centex Studies
Houston, Texas, 77058
Centex Studies
McAllen, Texas, 78504
Miami Dade Medical Research Institute
Miami, Florida, 33176
Infinite Clinical Trials
Morrow, Georgia, 30260
About this study
Official title: Phase 2, Double-blind, Randomized, Placebo-controlled Study of NasoVAX in the Prevention of Clinical Worsening in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
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.
Read the 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.
- Conditions
- Coronavirus Infection
- Being tested
- NasoVAX, Placebo
- Keywords
- COVID-19, SARS-CoV-2
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NasoVAXBiological
NasoVAX consists of replication-deficient adenovirus vectors in suspension
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| NasoVAX | Experimental | Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment). Receives: Biological: NasoVAX |
| Placebo | Placebo comparator | Participants will receive a single intranasal dose of placebo on Day 1 (enrollment). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Clinical Worsening
Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements
Measured: Day 1 to Day 14
Secondary outcomes (2)
Maximal Severity of COVID-19 After Treatment
Percentage of patients requiring hospitalization
Measured: Day 1 to Day 42
All-cause Mortality
All-cause mortality through Day 42
Measured: Day 1 to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start10 Oct 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Why it stopped: Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442230
- Sponsor's protocol ID
- ALT-601-201
- Status last verified
- Feb 2022
- First submitted
- 17 Jun 2020
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Double-blind, Randomized, Placebo-controlled Study of NasoVAX in the Prevention of Clinical Worsening in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04442230
- Acronym / sponsor ID
- ALT-601-201
- Conditions
- Coronavirus Infection
- Keywords
- COVID-19, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Posted 4 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NasoVAX | Experimental | Biological: NasoVAXParticipants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment). |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single intranasal dose of placebo on Day 1 (enrollment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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])
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NasoVAXNasoVAX consists of replication-deficient adenovirus vectors in suspension | Biological | NasoVAX |
| PlaceboNormal saline | Other | Placebo |
Primary outcome
Percentage of Patients With Clinical Worsening
Time frame: Day 1 to Day 14
Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements
2 secondary outcomes
Maximal Severity of COVID-19 After Treatment
Time frame: Day 1 to Day 42
All-cause Mortality
Time frame: Day 1 to Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NasoVAX in people with Coronavirus Infection, run by Altimmune, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Clinical Worsening (time frame: Day 1 to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.