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

NCT04442230 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: ALT-601-201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

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.

Conditions

Coronavirus Infection

Keywords

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Clinical Worsening

  Absolute 4.0% decrease from baseline in resting SpO2 on two consecutive measurements

  Day 1 to Day 14

Secondary Outcomes (2)

• Maximal Severity of COVID-19 After Treatment

  Day 1 to Day 42

• All-cause Mortality

  Day 1 to Day 42

Study Arms (2)

NasoVAX

EXPERIMENTAL

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

Biological: NasoVAX

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

NasoVAX BIOLOGICAL

NasoVAX consists of replication-deficient adenovirus vectors in suspension

NasoVAX

Placebo OTHER

Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (7)

Miami Dade Medical Research Institute

Miami, Florida, 33176, United States

Location

Infinite Clinical Trials

Morrow, Georgia, 30260, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

Next Level Urgent Care

Houston, Texas, 77057, United States

Location

Centex Studies

Houston, Texas, 77058, United States

Location

Centex Studies

McAllen, Texas, 78504, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Sarah K. Browne, MD/Senior Director, Clinical Development
• Organization: Altimmune, Inc.

sbrowne@altimmune.com

240-654-1450

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 22, 2020
• Study Start: October 10, 2020
• Primary Completion: February 15, 2021
• Study Completion: February 15, 2021
• Last Updated: April 4, 2022
• Results First Posted: April 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)