A Phase 3 Randomized Double Blind Efficacy and Safety Study of Oral Polio Vaccine and NA-831 for Covid-19

NCT04540185 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: OPV-NA831
• Study Type: interventional
• Target: 3,600
• Locations: 2 countries
• Sites: 10

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.

Conditions

Covid19; SARS (Severe Acute Respiratory Syndrome); SARS-CoV Infection; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831

  Number of participants infected with Covid-19 after second dose

  Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)

• Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal

  Number of participants with adverse events

  Time Frame: Up to Day 365 (1 years after second dose)

Secondary Outcomes (2)

• Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831

  Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose)

• 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

  Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose)

Study Arms (6)

Standard dose bivalent oral polio vaccine

EXPERIMENTAL

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

Biological: Biological: oral polio vaccine

Comparable Placebo- 0.10 mg/kg

PLACEBO COMPARATOR

Saline administered orally on a sugar lump

Biological: Comparable Placebo

Standard dose of NA-831

EXPERIMENTAL

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

Drug: NA-831

Comparable Placebo- 30mg

PLACEBO COMPARATOR

30 mg of placebo in a capsule administered orally

Drug: Comparable Placebo of drug

Standard dose of bivalent OPV and NA-831

EXPERIMENTAL

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

Combination Product: Combination of oral polio vaccine and NA-831

Comparable Placebo

PLACEBO COMPARATOR

Placebo of a vaccine administered orally on a sugar lump Plus 30 mg of a placebo in a capsule administered orally

Combination Product: Comparable Placebo of Oral Polio Vaccine and Placebo of drug

Interventions

Biological: oral polio vaccine BIOLOGICAL

Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump

Also known as: Oral Polio Vaccine (OPV)

Standard dose bivalent oral polio vaccine

Comparable Placebo BIOLOGICAL

Placebo of a vaccine 0.1 ml administered orally on a sugar lump

Also known as: Placebo comparator

Comparable Placebo- 0.10 mg/kg

NA-831 DRUG

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

Also known as: NA-81 is a neuroprotective drug

Standard dose of NA-831

Comparable Placebo of drug DRUG

Placebo 30 mg in a capsule administered orally

Also known as: Placebo comparator

Comparable Placebo- 30mg

Combination of oral polio vaccine and NA-831 COMBINATION_PRODUCT

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

Also known as: OPV and Drug combination

Standard dose of bivalent OPV and NA-831

Comparable Placebo of Oral Polio Vaccine and Placebo of drug COMBINATION_PRODUCT

Combination of biological placebo 0.1 ml administered orally on a sugar lump and drug placebo 30 mg in a capsule administered orally

Also known as: Placebo Comparator

Comparable Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biomed Industries, Inc.: lead

Study Sites (10)

Coronavirus Research Institute- Testing Site

Los Angeles, California, 90095, United States

Location

Coronavirus Research Institute

Orange, California, 92868, United States

Location

Coronavirus Research Institute-Testing Site

Palo Alto, California, 94304, United States

Location

Coronavirus Research Testing Site

San Francisco, California, 94110, United States

Location

Coronavirus Research Institute-Testing Site

Sunnyvale, California, 94086, United States

Location

Coronavirus Research Institute

Sunnyvale, California, 94086, United States

Location

Coronavirus Research Institute-Testing Site

Naperville, Illinois, 60540, United States

Location

Coronavirus Research Institute-Testing Site-

The Bronx, New York, 10467, United States

Location

NeuroActiva-Clinical Research Unit

Auckland, 1010, New Zealand

Location

NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd

Auckland, New Zealand

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Poliovirus Vaccine, Oral; Drug Combinations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Lloyd Tran, PhD

  Coronavirus Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 7, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 31, 2022
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 90 days after completion of the study
• Access Criteria: To be verified and determined at a later date

Locations

US (8); NZ (2)