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

NCT04540185 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3600

Last updated 2020-09-09

No results posted yet for this study

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

Interventions

BIOLOGICAL

Biological: oral polio vaccine

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

BIOLOGICAL

Comparable Placebo

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

DRUG

NA-831

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

DRUG

Comparable Placebo of drug

Placebo 30 mg 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

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

Sponsors & Collaborators

  • Biomed Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Lloyd Tran, PhD · Coronavirus Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-11-01
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04540185 on ClinicalTrials.gov