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A Phase 3 Randomized Double Blind Efficacy and Safety Study of Oral Polio Vaccine and NA-831 for Covid-19 (OPV-NA831)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540185
Recruitment Status : Enrolling by invitation
First Posted : September 7, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Biomed Industries, Inc.
Information provided by (Responsible Party):
NeuroActiva, Inc.

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.

Condition or disease Intervention/treatment Phase
Covid19 SARS (Severe Acute Respiratory Syndrome) SARS-CoV Infection SARS-CoV-2 Biological: Biological: oral polio vaccine Biological: Comparable Placebo Drug: NA-831 Drug: 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 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Standard dose bivalent oral polio vaccine
Biological: oral polio vaccine Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
Biological: Biological: oral polio vaccine
Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
Other Name: Oral Polio Vaccine (OPV)

Placebo Comparator: Comparable Placebo- 0.10 mg/kg
Saline administered orally on a sugar lump
Biological: Comparable Placebo
Placebo of a vaccine 0.1 ml administered orally on a sugar lump
Other Name: Placebo comparator

Experimental: Standard dose of NA-831
Drug: neuroprotection NA-831 30 mg of NA-831in a capsule administered orally
Drug: NA-831
Drug: NA-831 30 mg of NA-831 in a capsule administered orally
Other Name: NA-81 is a neuroprotective drug

Placebo Comparator: Comparable Placebo- 30mg
30 mg of placebo in a capsule administered orally
Drug: Comparable Placebo of drug
Placebo 30 mg in a capsule administered orally
Other Name: Placebo comparator

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
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
Other Name: OPV and Drug combination

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
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
Other Name: Placebo Comparator




Primary Outcome Measures :
  1. Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of OPV with or without NA-831 [ Time Frame: Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose) ]
    Number of participants infected with Covid-19 after second dose

  2. Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal [ Time Frame: Time Frame: Up to Day 365 (1 years after second dose) ]
    Number of participants with adverse events


Secondary Outcome Measures :
  1. 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: Time Frame: Day 29 (second dose) up to Day 365 (1 years after second dose) ]
    Clinical signs indicative of severe COVID-19 as predefined for the study.

  2. 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: Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose) ]
    Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04540185


Locations
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United States, California
Coronavirus Research Institute- Testing Site
Los Angeles, California, United States, 90095
Coronavirus Research Institute
Orange, California, United States, 92868
Coronavirus Research Institute-Testing Site
Palo Alto, California, United States, 94304
Coronavirus Research Testing Site
San Francisco, California, United States, 94110
Coronavirus Research Institute-Testing Site
Sunnyvale, California, United States, 94086
Coronavirus Research Institute
Sunnyvale, California, United States, 94086
United States, Illinois
Coronavirus Research Institute-Testing Site
Naperville, Illinois, United States, 60540
United States, New York
Coronavirus Research Institute-Testing Site-
Bronx, New York, United States, 10467
New Zealand
NeuroActiva-Clinical Research Unit
Auckland, New Zealand, 1010
NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd
Auckland, New Zealand
Sponsors and Collaborators
NeuroActiva, Inc.
Biomed Industries, Inc.
Investigators
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Study Director: Lloyd Tran, PhD Coronavirus Research Institute
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Responsible Party: NeuroActiva, Inc.
ClinicalTrials.gov Identifier: NCT04540185    
Other Study ID Numbers: OPV-NA831
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share the Study Protocol and other information if needed
Supporting Materials: Study Protocol
Time Frame: 90 days after completion of the study
Access Criteria: To be verified and determined at a later date

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Neuroprotective Agents
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Protective Agents