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

• ClinicalTrials.gov Identifier: NCT04442230
• Recruitment Status: Terminated
• First Posted: June 22, 2020
• Results First Posted: April 4, 2022
• Last Update Posted: April 4, 2022
• Sponsor: Altimmune, Inc.
• Information provided by (Responsible Party): Altimmune, Inc.

Tracking Information

• First Submitted Date: June 17, 2020
• First Posted Date: June 22, 2020
• Results First Submitted Date: February 7, 2022
• Results First Posted Date: April 4, 2022
• Last Update Posted Date: April 4, 2022
• Actual Study Start Date: October 10, 2020
• Actual Primary Completion Date: February 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 31, 2022)

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

Original Primary Outcome Measures (submitted: June 19, 2020)

Proportion of patients with clinical worsening [ Time Frame: Day 1 to Day 14 ]

Decrease from baseline in mean resting SpO2

Current Secondary Outcome Measures (submitted: March 31, 2022)

• Maximal Severity of COVID-19 After Treatment [ Time Frame: Day 1 to Day 42 ]
  Percentage of patients requiring hospitalization
• All-cause Mortality [ Time Frame: Day 1 to Day 42 ]
  All-cause mortality through Day 42

Original Secondary Outcome Measures (submitted: June 19, 2020)

• Maximal severity of COVID-19 after treatment [ Time Frame: Day 1 to Day 42 ]
  Proportion of patients requiring hospitalization
• All-cause mortality [ Time Frame: Day 1 to Day 42 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19)
• 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)
• 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.

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 Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Double-Blind

Primary Purpose: Treatment

• Condition: Coronavirus Infection

Intervention

• Biological: NasoVAX
  NasoVAX consists of replication-deficient adenovirus vectors in suspension
• Other: Placebo
  Normal saline

Study Arms

• Experimental: NasoVAX
  Participants will receive a single intranasal dose of NasoVAX on Day 1 (enrollment).
  Intervention: Biological: NasoVAX
• Placebo Comparator: Placebo
  Participants will receive a single intranasal dose of placebo on Day 1 (enrollment).
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 13, 2021): 48
• Original Estimated Enrollment (submitted: June 19, 2020): 96
• Actual Study Completion Date: February 15, 2021
• Actual Primary Completion Date: February 15, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. 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).
2. Men and women 18 years of age and older
3. 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.
4. Resting SpO2 ≥ 96.0% on room air on two successive measurements

5. 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
6. 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
7. Ability and willingness to comply with all aspects of the study, including reliable internet access, through the entire study period

Exclusion Criteria:

1. Pregnant or lactating women or planning to conceive a child during the next 3 months
2. Resting respiratory rate >20 breaths/min on room air or resting pulse rate ≥ 125 beats per minute
3. 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
4. Any chronic pulmonary disease, including chronic obstructive pulmonary disease and asthma, or other respiratory diseases that could exacerbate independent of COVID-19

5. 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:

   1. Severe obesity, defined as body mass index ≥ 40 kg/m2

   2. 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
6. History of Bell's Palsy
7. 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.
8. 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
9. 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
10. 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04442230
• Other Study ID Numbers: ALT-601-201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Altimmune, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Altimmune, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Altimmune, Inc.
• Verification Date: February 2022