Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04540185




Registration number
NCT04540185
Ethics application status
Date submitted
4/09/2020
Date registered
7/09/2020
Date last updated
9/09/2020

Titles & IDs
Public title
A Phase 3 Randomized Double Blind Efficacy and Safety Study of Oral Polio Vaccine and NA-831 for Covid-19
Scientific title
A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Polio Vaccine and NA-831 for Prophylaxis and Treatment of Early Onset of Covid-19
Secondary ID [1] 0 0
OPV-NA831
Universal Trial Number (UTN)
Trial acronym
OPV-NA831
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
SARS (Severe Acute Respiratory Syndrome) 0 0
SARS-CoV Infection 0 0
SARS-CoV-2 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Biological: oral polio vaccine
Other interventions - Comparable Placebo
Treatment: Drugs - NA-831
Treatment: Drugs - Comparable Placebo of drug
Combination Product - Combination of oral polio vaccine and NA-831
Combination Product - Comparable Placebo of Oral Polio Vaccine and Placebo of drug

Experimental: Standard dose bivalent oral polio vaccine - Biological: oral polio vaccine Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump

Placebo Comparator: Comparable Placebo- 0.10 mg/kg - Saline administered orally on a sugar lump

Experimental: Standard dose of NA-831 - Drug: neuroprotection NA-831 30 mg of NA-831in a capsule administered orally

Placebo Comparator: Comparable Placebo- 30mg - 30 mg of placebo in a capsule administered orally

Experimental: Standard dose of bivalent OPV and NA-831 - Biological: oral polio vaccine Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump Plus 30 mg of neuroprotection drug NA-831 in a capsule administered orally

Placebo Comparator: Comparable Placebo - Placebo of a vaccine administered orally on a sugar lump Plus 30 mg of a placebo in a capsule administered orally


Other interventions: Biological: oral polio vaccine
Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump

Other interventions: Comparable Placebo
Placebo of a vaccine 0.1 ml administered orally on a sugar lump

Treatment: Drugs: NA-831
Drug: NA-831 30 mg of NA-831 in a capsule administered orally

Treatment: Drugs: Comparable Placebo of drug
Placebo 30 mg in a capsule administered orally

Combination Product: Combination of oral polio vaccine and NA-831
Combination of biological: Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump and drug NA-831 30 mg in a capsule administered orally

Combination Product: Comparable Placebo of Oral Polio Vaccine and Placebo of drug
Combination of biological placebo 0.1 ml administered orally on a sugar lump and drug placebo 30 mg in a capsule administered orally
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831
Timepoint [1] 0 0
Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal
Timepoint [2] 0 0
Time Frame: Up to Day 365 (1 years after second dose)
Secondary outcome [1] 0 0
Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831
Timepoint [1] 0 0
Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)
Secondary outcome [2] 0 0
Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of OPV with or without NA-831 or Placebo regardless of evidence of prior SARS-CoV-2 Infection
Timepoint [2] 0 0
Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose)

Eligibility
Key inclusion criteria
- Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose
locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and
COVID-19.

- Understands and agrees to comply with the study procedures and provides written
informed consent.

- Able to comply with study procedures based on the assessment of the Investigator.

- Female participants of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as surgically sterile (history of bilateral
tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as
amenorrhea for =12 consecutive months prior to Screening without an alternative
medical cause). A follicle-stimulating hormone (FSH) level may be measured at the
discretion of the Investigator to confirm postmenopausal status.

- Female participants of childbearing potential may be enrolled in the study if the
participant fulfills all the following criteria:

- Has a negative pregnancy test at Screening and on the day of the first dose (Day
1).

- Has practiced adequate contraception or has abstained from all activities that
could result in pregnancy for at least 28 days prior to the first dose (Day 1).

- Has agreed to continue adequate contraception through 3 months following the
second dose on Day 29.

- Is not currently breastfeeding.

- Male participants engaging in activity that could result in pregnancy of sexual
partners must agree to practice adequate contraception and refrain from sperm donation
from the time of the first dose and through 3 months after the second dose.

- Healthy adults or adults with pre-existing medical conditions who are in stable
condition. A stable medical condition is defined as disease not requiring significant
change in therapy or hospitalization for worsening disease during the 3 months before
enrollment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Is acutely ill or febrile 72 hours prior to or at Screening. Fever is defined as a
body temperature =38.0°C/100.4°F. Participants meeting this criterion may be
rescheduled within the relevant window periods. Afebrile participants with minor
illnesses can be enrolled at the discretion of the Investigator.

- Is pregnant or breastfeeding.

- Known history of SARS-CoV-2 infection.

- Prior administration of an investigational coronavirus (SARS-CoV, Middle East
Respiratory Syndrome [MERS]-CoV) vaccine or current/planned simultaneous participation
in another interventional study to prevent or treat COVID-19.

- Demonstrated inability to comply with the study procedures.

- An immediate family member or household member of this study's personnel.

- History of anaphylaxis, urticaria, or other significant adverse reaction requiring
medical intervention after receipt of a vaccine.

- Bleeding disorder considered a contraindication to intramuscular injection or
phlebotomy.

- Has received or plans to receive a vaccine within 28 days prior to the first dose (Day
1) or plans to receive a non-study vaccine within 28 days prior to or after any dose
of investigational product (except for seasonal influenza vaccine).

- Has participated in an interventional clinical study within 28 days prior to the day
of enrollment.

- Immunosuppressive or immunodeficient state, including human immunodeficiency virus
(HIV) infection, asplenia, and recurrent severe infections.

- Has received systemic immunosuppressants or immune-modifying drugs for >14 days in
total within 6 months prior to Screening (for corticosteroids =20 milligram (mg)/day
of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days
prior to Screening.

- Has received systemic immunoglobulins or blood products within 3 months prior to the
day of Screening.

- Has donated =450 milliliters (mL) of blood products within 28 days prior to Screening.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
3600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
NeuroActiva, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Biomed Industries, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In this randomized double blind Phase 3 clinical trial we will study the efficacy and safety
of oral polio vaccine with and without NA-831 versus placebo.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04540185
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lloyd Tran, PhD
Address 0 0
Coronavirus Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04540185