NCT04540185

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,600 (estimated)
• Sponsor: Biomed Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-11-01
• Completion: 2022-12-31
• First posted: 2020-09-07
• Last updated: 2020-09-09

Locations

10 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated drug study