NA-831 for Coronavirus (OPV-NA831 Trial)

Phase 3

Waitlist Available

Research Sponsored by Biomed Industries, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: day 29 (second dose) up to day 365 (1 years after second dose)

Awards & highlights

Pivotal Trial

Summary

This trial will study if oral polio vaccine is effective and safe when given with and without NA-831, compared to placebo.

Eligible Conditions

Coronavirus
SARS
COVID-19

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: day 29 (second dose) up to day 365 (1 years after second dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: day 29 (second dose) up to day 365 (1 years after second dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: day 29 (second dose) up to day 365 (1 years after second dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Standard dose of bivalent OPV and NA-831Experimental Treatment1 Intervention

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 II: Standard dose of NA-831Experimental Treatment1 Intervention

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

Group III: Standard dose bivalent oral polio vaccineExperimental Treatment1 Intervention

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

Group IV: Comparable PlaceboPlacebo Group1 Intervention

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

Group V: Comparable Placebo- 0.10 mg/kgPlacebo Group1 Intervention

Saline administered orally on a sugar lump

Group VI: Comparable Placebo- 30mgPlacebo Group1 Intervention

30 mg of placebo in a capsule administered orally

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