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

NCT ID: NCT04540185

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 3600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

Early clinical studies showed that besides protecting against poliomyelitis, oral polio vaccine (OPV) reduced the number of other viruses that could be isolated from immunized children, compared with placebo recipients.

Both poliovirus and coronavirus are positive-strand RNA viruses; therefore, it is likely that they may induce and be affected by common innate immunity mechanisms. Recent reports indicate that COVID-19 may result in suppressed innate immune responses. Stimulation by live attenuated oral polio vaccines could increase resistance to infection by the causal virus, severe acute respiratory syndrome-SARS-CoV-2.

It has been discovered that SARS-CoV-2 viruses (Covid-19) can directly invade the nervous system of patients, instead of injuring the nervous system through the immune response. Increasing evidence suggests that infection with SARS-CoV-2 causes neurological deficits in a substantial proportion of affected patients. It was observed that patients surviving COVID-19 are at high risk for subsequent development of neurological disease and in particular Alzheimer's disease.

NA-831 is a new neuroprotective and neurogenesis drug that has been demonstrated its promising safety and efficacy in Phase 2A for the treatment of early onset ofAlzheimer's disease. NA-831 in oral formulation is well tolerated NA-831 with no adverse effects.

The Phase 3 clinical trial will evaluate the safety and efficacy of OPV with and without NA-831 versus placebo.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Standard dose bivalent oral polio vaccine

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

Group Type: EXPERIMENTAL

Biological: oral polio vaccine

Intervention Type: BIOLOGICAL

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

Comparable Placebo- 0.10 mg/kg

Saline administered orally on a sugar lump

Group Type: PLACEBO_COMPARATOR

Comparable Placebo

Intervention Type: BIOLOGICAL

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

Standard dose of NA-831

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

Group Type: EXPERIMENTAL

NA-831

Intervention Type: DRUG

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

Comparable Placebo- 30mg

30 mg of placebo in a capsule administered orally

Group Type: PLACEBO_COMPARATOR

Comparable Placebo of drug

Intervention Type: DRUG

Placebo 30 mg in a capsule administered orally

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

Group Type: EXPERIMENTAL

Combination of oral polio vaccine and NA-831

Intervention Type: 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

Comparable Placebo

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

Group Type: PLACEBO_COMPARATOR

Comparable Placebo of Oral Polio Vaccine and Placebo of drug

Intervention Type: 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

Interventions

Biological: oral polio vaccine

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

Intervention Type: BIOLOGICAL

Comparable Placebo

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

Intervention Type: BIOLOGICAL

NA-831

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

Intervention Type: DRUG

Comparable Placebo of drug

Placebo 30 mg in a capsule administered orally

Intervention Type: DRUG

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

Intervention Type: 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 Type: COMBINATION_PRODUCT

Other Intervention Names

Oral Polio Vaccine (OPV); Placebo comparator; NA-81 is a neuroprotective drug; Placebo comparator; OPV and Drug combination; Placebo Comparator

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biomed Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lloyd Tran, PhD

Role: STUDY_DIRECTOR

Coronavirus Research Institute

Locations

Coronavirus Research Institute- Testing Site

Los Angeles, California, United States

Coronavirus Research Institute

Orange, California, United States

Coronavirus Research Institute-Testing Site

Palo Alto, California, United States

Coronavirus Research Testing Site

San Francisco, California, United States

Coronavirus Research Institute-Testing Site

Sunnyvale, California, United States

Coronavirus Research Institute

Sunnyvale, California, United States

Coronavirus Research Institute-Testing Site

Naperville, Illinois, United States

Coronavirus Research Institute-Testing Site-

The Bronx, New York, United States

NeuroActiva-Clinical Research Unit

Auckland, , New Zealand

NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd

Auckland, , New Zealand

Countries

United States; New Zealand

Other Identifiers

OPV-NA831

Identifier Type: -

Identifier Source: org_study_id