Covid19Phase 3OPV-NA831NCT04540185
A Phase 3 Randomized Double Blind Efficacy and Safety Study of Oral Polio Vaccine and NA-831 for Covid-19
A Phase 3 study testing Biological: oral polio vaccine, NA-831 and Combination of oral polio vaccine and NA-831 in people with Covid19 and SARS (Severe Acute Respiratory Syndrome), run by Biomed Industries, Inc. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS (Severe Acute Respiratory Syndrome), SARS-CoV Infection
- What is being tested?
- Biological: oral polio vaccine, NA-831 and Combination of oral polio vaccine and NA-831
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,600 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Nov 2020to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Coronavirus Research Institute- Testing Site
Los Angeles, California, 90095
Coronavirus Research Institute-Testing Site
Naperville, Illinois, 60540
Coronavirus Research Institute
Orange, California, 92868
Coronavirus Research Institute-Testing Site
Palo Alto, California, 94304
Coronavirus Research Testing Site
San Francisco, California, 94110
Coronavirus Research Institute-Testing Site
Sunnyvale, California, 94086
Coronavirus Research Institute
Sunnyvale, California, 94086
Coronavirus Research Institute-Testing Site-
The Bronx, New York, 10467
New Zealand2 sites
NeuroActiva-Clinical Research Unit
Auckland, 1010
NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd
Auckland
About this study
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
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.
Read the 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.
- Being tested
- Biological: oral polio vaccine, Comparable Placebo, NA-831, Comparable Placebo of drug, Combination of oral polio vaccine and NA-831
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: oral polio vaccineBiological
Also called Oral Polio Vaccine (OPV)
Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
Comparable PlaceboBiological
Also called Placebo comparator
Placebo of a vaccine 0.1 ml administered orally on a sugar lump
NA-831Drug
Also called NA-81 is a neuroprotective drug
Drug: NA-831 30 mg of NA-831 in a capsule administered orally
Comparable Placebo of drugDrug
Also called Placebo comparator
Placebo 30 mg in a capsule administered orally
Combination of oral polio vaccine and NA-831Combination product
Also called OPV and Drug combination
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 of Oral Polio Vaccine and Placebo of drugCombination product
Also called Placebo Comparator
Combination of biological placebo 0.1 ml administered orally on a sugar lump and drug placebo 30 mg in a capsule administered orally
| Study group | Role | What they receive |
|---|---|---|
| Standard dose bivalent oral polio vaccine | Experimental | Biological: oral polio vaccine Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump Receives: Biological: Biological: oral polio vaccine |
| Comparable Placebo- 0.10 mg/kg | Placebo comparator | Saline administered orally on a sugar lump Receives: Biological: Comparable Placebo |
| Standard dose of NA-831 | Experimental | Drug: neuroprotection NA-831 30 mg of NA-831in a capsule administered orally Receives: Drug: NA-831 |
| Comparable Placebo- 30mg | Placebo comparator | 30 mg of placebo in a capsule administered orally Receives: 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 Receives: 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 Receives: Combination Product: Comparable Placebo of Oral Polio Vaccine and Placebo of drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Clinical signs indicative of severe COVID-19 as predefined for the study.
Measured: 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
Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.
Measured: Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomed Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lloyd Tran, PhD, Study director, Coronavirus Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540185
- Sponsor's protocol ID
- OPV-NA831
- Acronym
- OPV-NA831
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the Study Protocol and other information if needed
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04540185
- Acronym / sponsor ID
- OPV-NA831 / OPV-NA831
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Biomed Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Standard dose bivalent oral polio vaccine | Experimental | Biological: Biological: oral polio vaccineBiological: oral polio vaccine Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump |
| Comparable Placebo- 0.10 mg/kg | Placebo comparator | Biological: Comparable PlaceboSaline administered orally on a sugar lump |
| Standard dose of NA-831 | Experimental | Drug: NA-831Drug: neuroprotection NA-831 30 mg of NA-831in a capsule administered orally |
| Comparable Placebo- 30mg | Placebo comparator | Drug: Comparable Placebo of drug30 mg of placebo in a capsule administered orally |
| Standard dose of bivalent OPV and NA-831 | Experimental | Combination Product: Combination of oral polio vaccine and NA-831Biological: 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 |
| Comparable Placebo | Placebo comparator | Combination Product: Comparable Placebo of Oral Polio Vaccine and Placebo of drugPlacebo of a vaccine administered orally on a sugar lump Plus 30 mg of a placebo in a capsule administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: oral polio vaccineAlso: Oral Polio Vaccine (OPV)Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump | Biological | Standard dose bivalent oral polio vaccine |
| Comparable PlaceboAlso: Placebo comparatorPlacebo of a vaccine 0.1 ml administered orally on a sugar lump | Biological | Comparable Placebo- 0.10 mg/kg |
| NA-831Also: NA-81 is a neuroprotective drugDrug: NA-831 30 mg of NA-831 in a capsule administered orally | Drug | Standard dose of NA-831 |
| Comparable Placebo of drugAlso: Placebo comparatorPlacebo 30 mg in a capsule administered orally | Drug | Comparable Placebo- 30mg |
| Combination of oral polio vaccine and NA-831Also: OPV and Drug combinationCombination 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 | Standard dose of bivalent OPV and NA-831 |
| Comparable Placebo of Oral Polio Vaccine and Placebo of drugAlso: Placebo ComparatorCombination of biological placebo 0.1 ml administered orally on a sugar lump and drug placebo 30 mg in a capsule administered orally | Combination product | Comparable Placebo |
Primary outcome
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
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
2 secondary outcomes
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Yes. We plan to share the Study Protocol and other information if needed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lloyd Tran, PhD study director
Coronavirus Research Institute
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biological: oral polio vaccine, NA-831 and Combination of oral polio vaccine and NA-831 in people with Covid19 and SARS (Severe Acute Respiratory Syndrome), run by Biomed Industries, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.